<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02998125</url>
  </required_header>
  <id_info>
    <org_study_id>USalford-Bsheeha</org_study_id>
    <nct_id>NCT02998125</nct_id>
  </id_info>
  <brief_title>An Exploration of Outcomes Post-total Knee Arthroplasty in Middle East</brief_title>
  <official_title>A Psychometric Analysis of the Arabic Version of Oxford Knee Score Before and After Total Knee Arthroplasty in a Middle East Population and an Exploration of Outcomes Post-total Knee Arthroplasty in the Middle East</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Salford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King Khalid University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Princess Nourah Bint Abdulrahman University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Salford</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The intention is to explore whether there are factors, which can help us to understand why&#xD;
      some patient outcomes, following total knee arthroplasty are not successful and identify&#xD;
      prediction factors for progression. Assessment of outcomes pre- and post-surgery with&#xD;
      objective tools is a way to explore prediction tools for good/poor progression and improve&#xD;
      patient selection and timing for surgery.&#xD;
&#xD;
      The first aim of this project is determine the psychometric properties of the Arabic Version&#xD;
      of Oxford Knee Score, including internal consistency, reliability and validity before and&#xD;
      post-total knee arthroplasty in both males and females in a Middle East population. The&#xD;
      second aim is to assess the reliability of the Star Excursion Balance Test for measuring the&#xD;
      dynamic balance. The final aim is explore outcomes post-total knee arthroplasty among Middle&#xD;
      East patients using the Arabic Version of Oxford Knee Score, physical activity measures and&#xD;
      performance-based measurements such as: 30 s chair-stand test, stair-climb test, timed&#xD;
      up-and-go test and a 6 m walk test while adhering to Osteoarthritis Research Society&#xD;
      International recommendations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Project objectives&#xD;
&#xD;
      To gain an understanding of recovery post-TKA in a Saudi population and explore whether there&#xD;
      are factors which can help us to understand why some patient outcomes are not successful and&#xD;
      identify prediction factors for progression. It is a prospective study measuring outcomes six&#xD;
      months post-TKA with the following objectives:&#xD;
&#xD;
        -  Examine the internal consistency, reliability and validity of the Arabic Version of&#xD;
           Oxford Knee Score before and after total knee arthroplasty in both male and female&#xD;
           Middle East patients.&#xD;
&#xD;
        -  Examine the test- re-test reliability of the Star Excursion Balance Test in both male&#xD;
           and female Middle Eastern patients.&#xD;
&#xD;
        -  Measure patient outcomes post-total knee arthroplasty using patient self-reporting&#xD;
           activity measurements and the Arabic Version of Oxford Knee Score;&#xD;
&#xD;
        -  Evaluate physical activity level improvements post-knee arthroplasty using objective&#xD;
           methods and an accelerometer: ActivPAL;&#xD;
&#xD;
        -  Assess functional recovery post-knee arthroplasty according to Osteoarthritis Research&#xD;
           Society International recommendations using performance-based measurements, such as: 30&#xD;
           s chair-stand test, stair-climb test, timed up-and-go test and a 6 m walk test alongside&#xD;
           functional balance.&#xD;
&#xD;
      The rationale which led to this project;&#xD;
&#xD;
      Knee osteoarthritis (OA) is a major cause of disability around the world; it is the most&#xD;
      common chronic condition in primary care in the UK. By 2030 it is predicted to be the&#xD;
      greatest cause of disability in the general population . An effective end-stage treatment for&#xD;
      knee OA is knee-replacement surgery, which was first done in the 1970s and 1980s.&#xD;
&#xD;
      In England and Wales, the number of knee-replacement procedures recorded by the National&#xD;
      Joint Registry in 2013 was 91,703, which represents an increase of 0.9 % over 2012. The data&#xD;
      analysis by the National Joint Registry and the Office of National Statistics suggests that,&#xD;
      by 2030, primary TKAs will increase by 117% from the 2012 level. Subsequently, TKA revision&#xD;
      surgeries are expected to increase incrementally by 332%. There is a similar estimation of&#xD;
      demand for revision TKA surgeries in the United States; by 2030, they are expected to rise by&#xD;
      601% from the 2005 level. The United States estimation of primary TKA is for growth of 673%&#xD;
      from the 2005 level, which is similar to England and Wales's upper-limit projections.&#xD;
&#xD;
      Post-TKA, 75-85% of patients report satisfaction with surgery outcomes, while the remaining&#xD;
      15-25% are dissatisfied (Klit, Jacobsen, Rosenlund, Sonne-Holm, &amp; Troelsen, 2014). Total knee&#xD;
      arthroplasty's success has traditionally been evaluated from the surgeon's perspective, e.g.&#xD;
      the presence of surgical complications or implant survival. This is gradually changing to&#xD;
      involve the patient in measuring health outcomes and decision-making processes.&#xD;
      Patient-reported outcome measures (PROMs) have evolved to explore patient perspectives by&#xD;
      monitoring the quality of care in health organizations and conducting clinical trial&#xD;
      outcomes.&#xD;
&#xD;
      PROM results cannot exclude the Research Participant Effect (RPE) or subjective&#xD;
      over/underestimation due to psychosocial effects or pain from other joints, such as hips or&#xD;
      back. Hence, objective clinical evaluation methods can minimize patients' subjective&#xD;
      over/underestimations of outcomes, though RPE can not be excluded. Objective assessment has&#xD;
      some advantages over PROMs, such as a lack of ceiling effects and more precision and&#xD;
      responsiveness, and it does not require cultural and language adaptation. Performance-based&#xD;
      Outcome Measures (PBOMs) have the advantage of being objective measures that do not overlap&#xD;
      with pain measurement. They are sensitive to detecting change, responsive, have a minimal&#xD;
      ceiling effect and are feasible.&#xD;
&#xD;
      PROMs and PBOM measurement tools assess different aspects of function post-TKA. PROMs mainly&#xD;
      assess patients' functional ability beliefs and experiences, while objective functional&#xD;
      assessment instruments and PBOM measurement tools evaluate patients' actual ability and&#xD;
      function. Therefore, to conduct comprehensive functional assessments post-TKA, PROMs,&#xD;
      objective functional assessment instruments and PBM measurement tools are recommended.&#xD;
&#xD;
      To the best of our knowledge, no study has explored the outcome post TKA using the PROMs,&#xD;
      PBOMs and functional balance measurement tools in Saudi male and female population or&#xD;
      explored possible accurate prediction factors for outcomes post-TKA. Reliable outcome&#xD;
      prediction could, however, improve patient selection for surgery, as appropriate timing for&#xD;
      surgery depends on patient symptoms and efficient patient preparation for surgery if it is to&#xD;
      be cost-effective. Accurate preoperative prediction is crucial to minimize the potential for&#xD;
      unrealistic expectations about outcomes.&#xD;
&#xD;
      This study will investigate outcomes post-total knee arthroplasty and factors that may&#xD;
      predict good/poor progression using three categories of outcome measurements in order to&#xD;
      minimize subjective over/ underestimation of surgical outcomes. Thus, the study seeks to&#xD;
      explore accurate and objective prediction factors of post-total knee arthroplasty&#xD;
      progression.&#xD;
&#xD;
      Potentially, reliable outcome predictions could improve patient selection for surgery, as&#xD;
      appropriate timing for surgery depends on patients' symptoms and efficient patient&#xD;
      preparation for surgery, if it is to be cost-effective. Accurate preoperative prediction is&#xD;
      crucial to minimize the potential for unrealistic expectations about outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">February 18, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Performance based measurements change in Thirty second chair-stand test</measure>
    <time_frame>one week before admission day and 6 months after surgery to assess the performance changes post-surgery</time_frame>
    <description>A chair of 17 inches (45cm) height is used as the starting position for patients sitting with their arms cross the chest. Patients are instructed to stand and then sit with good buttock placement and back support, their hands on arm rests and feet correctly placed, then stand again as fast and safely as they can. The assessor counts the number of complete chair stands within 30 s. The mean of two trials will be used for analysis (Gill &amp; McBurney, 2008; Unver, Kalkan, Yuksel, Kahraman, &amp; Karatosun, 2015)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance based measurements change in Stair-climb test</measure>
    <time_frame>one week before admission day and 6 months after surgery to assess the performance changes post-surgery</time_frame>
    <description>Using a stopwatch accurate to 1/100 s, an assessor will measure the time required for a patient, using a handrail if required, to ascend and descend a flight of twelve steps 18 cm high and 28 cm deep. Patients will be instructed to ascend and descend the stairs as quickly, safely and comfortably as they can. The mean of two trials will be used for analysis (Mizner et al., 2011)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance based measurements change in Timed up-and-go test</measure>
    <time_frame>one week before admission day and 6 months after surgery to assess the performance changes post-surgery</time_frame>
    <description>The test procedure will use a stopwatch accurate to 1/100 s; a chair of standard 45 cm height, with armrests, will be placed on an outdoor level footpath and a line 3 metres from the chair will be drawn. Patients will be instructed to stand up from the chair, using the arms if required, walk for 3 metres to the line, then turn round and walk to sit back down on the chair as quickly, safely and comfortably as they can. An assessor will start timing as the patient leans forward to stand up, and stop when the patient's hips make contact with the seat to sit down. An average of two repetitions will be analysed (Ko, Naylor, Harris, Crosbie, &amp; Yeo, 2013; Mizner et al., 2011; Podsiadlo &amp; Richardson, 1991).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance based measurements change in Six minute walk test</measure>
    <time_frame>one week before admission day and 6 months after surgery to assess the performance changes post-surgery</time_frame>
    <description>The test will measure how far patients can walk in 6 minutes along a level 25-metre footpath. Patients can use an assistive device if required, take a rest if necessary and have standardized encouragement after each minute. The assessor will ask the patient to stop after 6 minutes. Only one test will be performed to avoid fatigue (&quot;ATS Statement,&quot; 2002; Ko et al., 2013; Mizner et al., 2011).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Balance change</measure>
    <time_frame>one week before admission day and 6 months after surgery to assess the balance changes post-surgery</time_frame>
    <description>In the Star Excursion Balance Test, three tape measures will be fixed to the clinic floor, one oriented anteriorly to the apex and two aligned at 135° to the anterior tape in the posterolateral and posteromedial directions. (Fullam, Caulfield, Coughlan, &amp; Delahunt, 2014).&#xD;
The patient will stand in the center of the grid and be instructed to stand on the affected or operated leg while reaching out as far as possible in one of the three directions with the other lower extremity, and then return that leg to the center. The participant will be asked to perform the test barefoot, keeping the heel of the stance leg on the floor at all times and to bend the knee of the stance leg. If the participant does not carry out any of these instructions, the trial will repeated.&#xD;
The assessor will measure the reach distance in each direction in centimeters and then normalize the average of the three trials to leg length.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical activity measurements change will be assess using an activPAL activity monitor (PAL Technologies, Glasgow, UK)</measure>
    <time_frame>one week before admission day and 6 months after surgery to assess the physical activity changes post-surgery</time_frame>
    <description>an activPAL activity monitor (PAL Technologies, Glasgow, UK) as this proven accelerometer provides objective quantification of free-living physical activity without any modification (Dahlgren, Carlsson, Moorhead, Hager-Ross, &amp; McDonough, 2010; Schmalzried et al., 1998). It is suitable as it light in weight (20g), includes an inclinometer and is small in size (53 x 35 x 7 mm) Figure 3. The device is worn by patient's mid-thigh, secured by non-allergic waterproof adhesive tape under their clothes, for 7-10 days before surgery and 6 months after. Clear written and verbal instructions will be given to patients as they have to wear it all day and all night except, when bathing or swimming (they can take a shower with it on).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arabic versions of Oxford Knee Score Validity assessment</measure>
    <time_frame>one week before admission day</time_frame>
    <description>The patients will be instructed to complete the Arabic versions of Oxford Knee Score, Arabic versions of Knee injury and Osteoarthritis Outcome Score (KOOS) and visual analogue scale (VAS) before Arthroplasty as baseline data in order to assess the correlation of Arabic versions of Oxford Knee Score with the Arabic version of KOOS and VAS to determine construct validity (Arabic versions of Oxford Knee Score, Knee injury and Osteoarthritis Outcome Score and visual analogue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arabic versions of Oxford Knee Score Reliability assessment</measure>
    <time_frame>one week before admission day, admission day and 6 months after surgery and to evaluate the construct validity of the Arabic version of Oxford Knee Score</time_frame>
    <description>Patients will be asked to fill out Arabic forms independently without any interpretation to assess the Score reliability and responsiveness.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">116</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>before and after total knee arthroplasty</arm_group_label>
    <description>assess the functional outcome before and 6 months after total knee arthroplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total knee arthroplasty</intervention_name>
    <description>prospective assessments for the functional outcome before and after the total knee arthroplasty</description>
    <arm_group_label>before and after total knee arthroplasty</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The present study is a prospective six and twelve month follow-up trial to explore the&#xD;
        outcome post TKA in addition to assess the validity, reliability and responsiveness of the&#xD;
        Arabic version of Oxford Knee Score and the Star Excursion Balance Test with total knee&#xD;
        arthroplasty patients.&#xD;
&#xD;
        An information sheet will be given to all participants who agree to participate to clarify&#xD;
        the objectives of the study. Before participating, patients will need to sign a consent&#xD;
        form (Appendix 2) and they will have the right to clarify any concerns about the study with&#xD;
        the researcher. A patient's participation or otherwise will not affect the quality of&#xD;
        service, all patients will receive conventional orthopedic care and a standard level of&#xD;
        physiotherapy according to hospital protocols.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients will be asked to participate during preadmission orthopedics clinic visits to&#xD;
        King Khalid University Hospital in Riyadh if the patient;&#xD;
&#xD;
          -  Scheduled for elective primary unilateral total knee arthroplasty.&#xD;
&#xD;
          -  For end-stage knee osteoarthritis.&#xD;
&#xD;
          -  In a stable and controlled medical condition,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are scheduled for bilateral knee arthroplasty or unilateral knee revision surgery;&#xD;
&#xD;
          -  Cannot read and understand Arabic&#xD;
&#xD;
          -  Have limited function due to musculoskeletal conditions other than unilateral knee&#xD;
             osteoarthritis.&#xD;
&#xD;
          -  Have been diagnosed with uncontrolled diabetes mellitus or blood pressure.&#xD;
&#xD;
          -  Have been diagnosed with any neurologic disorders, such as stroke, Parkinson's disease&#xD;
             or multiple sclerosis.&#xD;
&#xD;
          -  Are morbidly obese and have a body mass index (BMI) greater than 40.&#xD;
&#xD;
          -  Have advance osteoporosis or some other unstable chronic disease.&#xD;
&#xD;
          -  Have been diagnosed with a peripheral vascular or uncontrolled cardiac disease.&#xD;
&#xD;
          -  Participant will further be excluded post-surgery if they develop any surgical&#xD;
             complications, such as deep vein thrombosis, uncontrolled infection or fracture.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>King Khalid University Hospital</name>
      <address>
        <city>Riyadh</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <reference>
    <citation>ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.</citation>
    <PMID>12091180</PMID>
  </reference>
  <reference>
    <citation>Bade MJ, Kohrt WM, Stevens-Lapsley JE. Outcomes before and after total knee arthroplasty compared to healthy adults. J Orthop Sports Phys Ther. 2010 Sep;40(9):559-67. doi: 10.2519/jospt.2010.3317.</citation>
    <PMID>20710093</PMID>
  </reference>
  <reference>
    <citation>Bade MJ, Wolfe P, Zeni JA, Stevens-Lapsley JE, Snyder-Mackler L. Predicting poor physical performance after total knee arthroplasty. J Orthop Res. 2012 Nov;30(11):1805-10. doi: 10.1002/jor.22140. Epub 2012 Apr 26.</citation>
    <PMID>22539338</PMID>
  </reference>
  <reference>
    <citation>Bullens PH, van Loon CJ, de Waal Malefijt MC, Laan RF, Veth RP. Patient satisfaction after total knee arthroplasty: a comparison between subjective and objective outcome assessments. J Arthroplasty. 2001 Sep;16(6):740-7. doi: 10.1054/arth.2001.23922.</citation>
    <PMID>11547372</PMID>
  </reference>
  <reference>
    <citation>Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.</citation>
    <PMID>22398175</PMID>
  </reference>
  <reference>
    <citation>Charoencholvanich K, Pongcharoen B. Oxford knee score and SF-36: translation &amp; reliability for use with total knee arthroscopy patients in Thailand. J Med Assoc Thai. 2005 Sep;88(9):1194-202.</citation>
    <PMID>16536104</PMID>
  </reference>
  <reference>
    <citation>Coughlan GF, Fullam K, Delahunt E, Gissane C, Caulfield BM. A comparison between performance on selected directions of the star excursion balance test and the Y balance test. J Athl Train. 2012 Jul-Aug;47(4):366-71. doi: 10.4085/1062-6050-47.4.03.</citation>
    <PMID>22889651</PMID>
  </reference>
  <reference>
    <citation>Dahlgren G, Carlsson D, Moorhead A, Hager-Ross C, McDonough SM. Test-retest reliability of step counts with the ActivPAL device in common daily activities. Gait Posture. 2010 Jul;32(3):386-90. doi: 10.1016/j.gaitpost.2010.06.022. Epub 2010 Jul 22.</citation>
    <PMID>20655228</PMID>
  </reference>
  <reference>
    <citation>Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.</citation>
    <PMID>23680877</PMID>
  </reference>
  <reference>
    <citation>Field, A. (2009). Discovering Statistics Using SPSS: SAGE Publications Ltd,.</citation>
  </reference>
  <reference>
    <citation>Fullam K, Caulfield B, Coughlan GF, Delahunt E. Kinematic analysis of selected reach directions of the Star Excursion Balance Test compared with the Y-Balance Test. J Sport Rehabil. 2014 Feb;23(1):27-35. doi: 10.1123/jsr.2012-0114. Epub 2013 Aug 12.</citation>
    <PMID>23945793</PMID>
  </reference>
  <reference>
    <citation>Gill S, McBurney H. Reliability of performance-based measures in people awaiting joint replacement surgery of the hip or knee. Physiother Res Int. 2008 Sep;13(3):141-52. doi: 10.1002/pri.411.</citation>
    <PMID>18697226</PMID>
  </reference>
  <reference>
    <citation>Gribble PA, Hertel J, Plisky P. Using the Star Excursion Balance Test to assess dynamic postural-control deficits and outcomes in lower extremity injury: a literature and systematic review. J Athl Train. 2012 May-Jun;47(3):339-57. doi: 10.4085/1062-6050-47.3.08.</citation>
    <PMID>22892416</PMID>
  </reference>
  <reference>
    <citation>Harris K, Dawson J, Doll H, Field RE, Murray DW, Fitzpatrick R, Jenkinson C, Price AJ, Beard DJ. Can pain and function be distinguished in the Oxford Knee Score in a meaningful way? An exploratory and confirmatory factor analysis. Qual Life Res. 2013 Nov;22(9):2561-8. doi: 10.1007/s11136-013-0393-x. Epub 2013 Mar 23.</citation>
    <PMID>23526094</PMID>
  </reference>
  <reference>
    <citation>Hertel J, Braham RA, Hale SA, Olmsted-Kramer LC. Simplifying the star excursion balance test: analyses of subjects with and without chronic ankle instability. J Orthop Sports Phys Ther. 2006 Mar;36(3):131-7. doi: 10.2519/jospt.2006.36.3.131.</citation>
    <PMID>16596889</PMID>
  </reference>
  <reference>
    <citation>Hossain FS, Konan S, Patel S, Rodriguez-Merchan EC, Haddad FS. The assessment of outcome after total knee arthroplasty: are we there yet? Bone Joint J. 2015 Jan;97-B(1):3-9. doi: 10.1302/0301-620X.97B1.34434.</citation>
    <PMID>25568406</PMID>
  </reference>
  <reference>
    <citation>Hossain FS, Patel S, Fernandez MA, Konan S, Haddad FS. A performance based patient outcome score for active patients following total knee arthroplasty. Osteoarthritis Cartilage. 2013 Jan;21(1):51-9. doi: 10.1016/j.joca.2012.09.019. Epub 2012 Oct 9.</citation>
    <PMID>23063619</PMID>
  </reference>
  <reference>
    <citation>Hyong IH, Kim JH. Test of intrarater and interrater reliability for the star excursion balance test. J Phys Ther Sci. 2014 Aug;26(8):1139-41. doi: 10.1589/jpts.26.1139. Epub 2014 Aug 30.</citation>
    <PMID>25202168</PMID>
  </reference>
  <reference>
    <citation>Impellizzeri FM, Mannion AF, Leunig M, Bizzini M, Naal FD. Comparison of the reliability, responsiveness, and construct validity of 4 different questionnaires for evaluating outcomes after total knee arthroplasty. J Arthroplasty. 2011 Sep;26(6):861-9. doi: 10.1016/j.arth.2010.07.027. Epub 2010 Nov 12.</citation>
    <PMID>21074964</PMID>
  </reference>
  <reference>
    <citation>Jagger, C., Matthews, R., Spiers, N., Brayne, C., Comas - Herrera, A., Robinson, T., . . . Croft, P. (2006). Compression or expansion of disability?: forecasting future disability levels under changing patterns of diseases: King's Fund.</citation>
  </reference>
  <reference>
    <citation>Jenny JY, Diesinger Y. Validation of a French version of the Oxford knee questionnaire. Orthop Traumatol Surg Res. 2011 May;97(3):267-71. doi: 10.1016/j.otsr.2010.07.009. Epub 2011 Jan 12.</citation>
    <PMID>21233035</PMID>
  </reference>
  <reference>
    <citation>Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord. 2005 Jan 28;6:3. doi: 10.1186/1471-2474-6-3.</citation>
    <PMID>15679884</PMID>
  </reference>
  <reference>
    <citation>Klit J, Jacobsen S, Rosenlund S, Sonne-Holm S, Troelsen A. Total knee arthroplasty in younger patients evaluated by alternative outcome measures. J Arthroplasty. 2014 May;29(5):912-7. doi: 10.1016/j.arth.2013.09.035. Epub 2013 Oct 1.</citation>
    <PMID>24269097</PMID>
  </reference>
  <reference>
    <citation>Ko V, Naylor JM, Harris IA, Crosbie J, Yeo AE. The six-minute walk test is an excellent predictor of functional ambulation after total knee arthroplasty. BMC Musculoskelet Disord. 2013 Apr 24;14:145. doi: 10.1186/1471-2474-14-145.</citation>
    <PMID>23617377</PMID>
  </reference>
  <reference>
    <citation>Lungu E, Desmeules F, Dionne CE, Belzile EL, Vendittoli PA. Prediction of poor outcomes six months following total knee arthroplasty in patients awaiting surgery. BMC Musculoskelet Disord. 2014 Sep 8;15:299. doi: 10.1186/1471-2474-15-299.</citation>
    <PMID>25201448</PMID>
  </reference>
  <reference>
    <citation>Lutzner C, Kirschner S, Lutzner J. Patient activity after TKA depends on patient-specific parameters. Clin Orthop Relat Res. 2014 Dec;472(12):3933-40. doi: 10.1007/s11999-014-3813-5. Epub 2014 Jul 23.</citation>
    <PMID>25053290</PMID>
  </reference>
  <reference>
    <citation>McCambridge J, Witton J, Elbourne DR. Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects. J Clin Epidemiol. 2014 Mar;67(3):267-77. doi: 10.1016/j.jclinepi.2013.08.015. Epub 2013 Nov 22.</citation>
    <PMID>24275499</PMID>
  </reference>
  <reference>
    <citation>Meiring RM, Frimpong E, Mokete L, Pietrzak J, Van Der Jagt D, Tikly M, McVeigh JA. Rationale, design and protocol of a longitudinal study assessing the effect of total knee arthroplasty on habitual physical activity and sedentary behavior in adults with osteoarthritis. BMC Musculoskelet Disord. 2016 Jul 13;17:281. doi: 10.1186/s12891-016-1141-5.</citation>
    <PMID>27411316</PMID>
  </reference>
  <reference>
    <citation>Mizner RL, Petterson SC, Clements KE, Zeni JA Jr, Irrgang JJ, Snyder-Mackler L. Measuring functional improvement after total knee arthroplasty requires both performance-based and patient-report assessments: a longitudinal analysis of outcomes. J Arthroplasty. 2011 Aug;26(5):728-37. doi: 10.1016/j.arth.2010.06.004. Epub 2010 Sep 20.</citation>
    <PMID>20851566</PMID>
  </reference>
  <reference>
    <citation>Naal FD, Impellizzeri FM, Sieverding M, Loibl M, von Knoch F, Mannion AF, Leunig M, Munzinger U. The 12-item Oxford Knee Score: cross-cultural adaptation into German and assessment of its psychometric properties in patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2009 Jan;17(1):49-52. doi: 10.1016/j.joca.2008.05.017. Epub 2008 Jul 7.</citation>
    <PMID>18602843</PMID>
  </reference>
  <reference>
    <citation>Palmer CR. Encyclopedia of biostatistics. BMJ. 1999 Feb 20;318(7182):542. doi: 10.1136/bmj.318.7182.542. No abstract available.</citation>
    <PMID>10024284</PMID>
  </reference>
  <reference>
    <citation>Patel A, Pavlou G, Mujica-Mota RE, Toms AD. The epidemiology of revision total knee and hip arthroplasty in England and Wales: a comparative analysis with projections for the United States. A study using the National Joint Registry dataset. Bone Joint J. 2015 Aug;97-B(8):1076-81. doi: 10.1302/0301-620X.97B8.35170.</citation>
    <PMID>26224824</PMID>
  </reference>
  <reference>
    <citation>Plichta, S., &amp; Kelvin, E. (2012). Munro's Statistical Methods for Health Care Research: Lippincott Williams &amp; Wilkins.</citation>
  </reference>
  <reference>
    <citation>Podsiadlo D, Richardson S. The timed &quot;Up &amp; Go&quot;: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.</citation>
    <PMID>1991946</PMID>
  </reference>
  <reference>
    <citation>Robinson RH, Gribble PA. Support for a reduction in the number of trials needed for the star excursion balance test. Arch Phys Med Rehabil. 2008 Feb;89(2):364-70. doi: 10.1016/j.apmr.2007.08.139.</citation>
    <PMID>18226664</PMID>
  </reference>
  <reference>
    <citation>Schmalzried TP, Szuszczewicz ES, Northfield MR, Akizuki KH, Frankel RE, Belcher G, Amstutz HC. Quantitative assessment of walking activity after total hip or knee replacement. J Bone Joint Surg Am. 1998 Jan;80(1):54-9.</citation>
    <PMID>9469309</PMID>
  </reference>
  <reference>
    <citation>Stratford PW, Kennedy DM. Performance measures were necessary to obtain a complete picture of osteoarthritic patients. J Clin Epidemiol. 2006 Feb;59(2):160-7. doi: 10.1016/j.jclinepi.2005.07.012. Epub 2005 Dec 27.</citation>
    <PMID>16426951</PMID>
  </reference>
  <reference>
    <citation>Thumboo J, Chew LH, Lewin-Koh SC. Socioeconomic and psychosocial factors influence pain or physical function in Asian patients with knee or hip osteoarthritis. Ann Rheum Dis. 2002 Nov;61(11):1017-20. doi: 10.1136/ard.61.11.1017.</citation>
    <PMID>12379527</PMID>
  </reference>
  <reference>
    <citation>Unver B, Kalkan S, Yuksel E, Kahraman T, Karatosun V. Reliability of the 50-foot walk test and 30-sec chair stand test in total knee arthroplasty. Acta Ortop Bras. 2015 Jul-Aug;23(4):184-7. doi: 10.1590/1413-78522015230401018.</citation>
    <PMID>26327798</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Salford</investigator_affiliation>
    <investigator_full_name>Bodor Bin sheeha</investigator_full_name>
    <investigator_title>PhD student at University of Salford</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02998125
org study id: USalford-Bsheeha
nct id: NCT02998125
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The intention is to explore whether there are factors, which can help us to understand why
      some patient outcomes, following total knee arthroplasty are not successful and identify
      prediction factors for progression. Assessment of outcomes pre- and post-surgery with
      objective tools is a way to explore prediction tools for good/poor progression and improve
      patient selection and timing for surgery.

      The first aim of this project is determine the psychometric properties of the Arabic Version
      of Oxford Knee Score, including internal consistency, reliability and validity before and
      post-total knee arthroplasty in both males and females in a Middle East population. The
      second aim is to assess the reliability of the Star Excursion Balance Test for measuring the
      dynamic balance. The final aim is explore outcomes post-total knee arthroplasty among Middle
      East patients using the Arabic Version of Oxford Knee Score, physical activity measures and
      performance-based measurements such as: 30 s chair-stand test, stair-climb test, timed
      up-and-go test and a 6 m walk test while adhering to Osteoarthritis Research Society
      International recommendations.
Project objectives

      To gain an understanding of recovery post-TKA in a Saudi population and explore whether there
      are factors which can help us to understand why some patient outcomes are not successful and
      identify prediction factors for progression. It is a prospective study measuring outcomes six
      months post-TKA with the following objectives:

        -  Examine the internal consistency, reliability and validity of the Arabic Version of
           Oxford Knee Score before and after total knee arthroplasty in both male and female
           Middle East patients.

        -  Examine the test- re-test reliability of the Star Excursion Balance Test in both male
           and female Middle Eastern patients.

        -  Measure patient outcomes post-total knee arthroplasty using patient self-reporting
           activity measurements and the Arabic Version of Oxford Knee Score;

        -  Evaluate physical activity level improvements post-knee arthroplasty using objective
           methods and an accelerometer: ActivPAL;

        -  Assess functional recovery post-knee arthroplasty according to Osteoarthritis Research
           Society International recommendations using performance-based measurements, such as: 30
           s chair-stand test, stair-climb test, timed up-and-go test and a 6 m walk test alongside
           functional balance.

      The rationale which led to this project;

      Knee osteoarthritis (OA) is a major cause of disability around the world; it is the most
      common chronic condition in primary care in the UK. By 2030 it is predicted to be the
      greatest cause of disability in the general population . An effective end-stage treatment for
      knee OA is knee-replacement surgery, which was first done in the 1970s and 1980s.

      In England and Wales, the number of knee-replacement procedures recorded by the National
      Joint Registry in 2013 was 91,703, which represents an increase of 0.9 % over 2012. The data
      analysis by the National Joint Registry and the Office of National Statistics suggests that,
      by 2030, primary TKAs will increase by 117% from the 2012 level. Subsequently, TKA revision
      surgeries are expected to increase incrementally by 332%. There is a similar estimation of
      demand for revision TKA surgeries in the United States; by 2030, they are expected to rise by
      601% from the 2005 level. The United States estimation of primary TKA is for growth of 673%
      from the 2005 level, which is similar to England and Wales's upper-limit projections.

      Post-TKA, 75-85% of patients report satisfaction with surgery outcomes, while the remaining
      15-25% are dissatisfied (Klit, Jacobsen, Rosenlund, Sonne-Holm, & Troelsen, 2014). Total knee
      arthroplasty's success has traditionally been evaluated from the surgeon's perspective, e.g.
      the presence of surgical complications or implant survival. This is gradually changing to
      involve the patient in measuring health outcomes and decision-making processes.
      Patient-reported outcome measures (PROMs) have evolved to explore patient perspectives by
      monitoring the quality of care in health organizations and conducting clinical trial
      outcomes.

      PROM results cannot exclude the Research Participant Effect (RPE) or subjective
      over/underestimation due to psychosocial effects or pain from other joints, such as hips or
      back. Hence, objective clinical evaluation methods can minimize patients' subjective
      over/underestimations of outcomes, though RPE can not be excluded. Objective assessment has
      some advantages over PROMs, such as a lack of ceiling effects and more precision and
      responsiveness, and it does not require cultural and language adaptation. Performance-based
      Outcome Measures (PBOMs) have the advantage of being objective measures that do not overlap
      with pain measurement. They are sensitive to detecting change, responsive, have a minimal
      ceiling effect and are feasible.

      PROMs and PBOM measurement tools assess different aspects of function post-TKA. PROMs mainly
      assess patients' functional ability beliefs and experiences, while objective functional
      assessment instruments and PBOM measurement tools evaluate patients' actual ability and
      function. Therefore, to conduct comprehensive functional assessments post-TKA, PROMs,
      objective functional assessment instruments and PBM measurement tools are recommended.

      To the best of our knowledge, no study has explored the outcome post TKA using the PROMs,
      PBOMs and functional balance measurement tools in Saudi male and female population or
      explored possible accurate prediction factors for outcomes post-TKA. Reliable outcome
      prediction could, however, improve patient selection for surgery, as appropriate timing for
      surgery depends on patient symptoms and efficient patient preparation for surgery if it is to
      be cost-effective. Accurate preoperative prediction is crucial to minimize the potential for
      unrealistic expectations about outcomes.

      This study will investigate outcomes post-total knee arthroplasty and factors that may
      predict good/poor progression using three categories of outcome measurements in order to
      minimize subjective over/ underestimation of surgical outcomes. Thus, the study seeks to
      explore accurate and objective prediction factors of post-total knee arthroplasty
      progression.

      Potentially, reliable outcome predictions could improve patient selection for surgery, as
      appropriate timing for surgery depends on patients' symptoms and efficient patient
      preparation for surgery, if it is to be cost-effective. Accurate preoperative prediction is
      crucial to minimize the potential for unrealistic expectations about outcomes.
observational model: Cohort
time perspective: Prospective
measure: Performance based measurements change in Thirty second chair-stand test
time frame: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
description: A chair of 17 inches (45cm) height is used as the starting position for patients sitting with their arms cross the chest. Patients are instructed to stand and then sit with good buttock placement and back support, their hands on arm rests and feet correctly placed, then stand again as fast and safely as they can. The assessor counts the number of complete chair stands within 30 s. The mean of two trials will be used for analysis (Gill & McBurney, 2008; Unver, Kalkan, Yuksel, Kahraman, & Karatosun, 2015)
measure: Performance based measurements change in Stair-climb test
time frame: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
description: Using a stopwatch accurate to 1/100 s, an assessor will measure the time required for a patient, using a handrail if required, to ascend and descend a flight of twelve steps 18 cm high and 28 cm deep. Patients will be instructed to ascend and descend the stairs as quickly, safely and comfortably as they can. The mean of two trials will be used for analysis (Mizner et al., 2011)
measure: Performance based measurements change in Timed up-and-go test
time frame: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
description: The test procedure will use a stopwatch accurate to 1/100 s; a chair of standard 45 cm height, with armrests, will be placed on an outdoor level footpath and a line 3 metres from the chair will be drawn. Patients will be instructed to stand up from the chair, using the arms if required, walk for 3 metres to the line, then turn round and walk to sit back down on the chair as quickly, safely and comfortably as they can. An assessor will start timing as the patient leans forward to stand up, and stop when the patient's hips make contact with the seat to sit down. An average of two repetitions will be analysed (Ko, Naylor, Harris, Crosbie, & Yeo, 2013; Mizner et al., 2011; Podsiadlo & Richardson, 1991).
measure: Performance based measurements change in Six minute walk test
time frame: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
description: The test will measure how far patients can walk in 6 minutes along a level 25-metre footpath. Patients can use an assistive device if required, take a rest if necessary and have standardized encouragement after each minute. The assessor will ask the patient to stop after 6 minutes. Only one test will be performed to avoid fatigue ("ATS Statement," 2002; Ko et al., 2013; Mizner et al., 2011).
measure: Balance change
time frame: one week before admission day and 6 months after surgery to assess the balance changes post-surgery
description: In the Star Excursion Balance Test, three tape measures will be fixed to the clinic floor, one oriented anteriorly to the apex and two aligned at 135° to the anterior tape in the posterolateral and posteromedial directions. (Fullam, Caulfield, Coughlan, & Delahunt, 2014).
The patient will stand in the center of the grid and be instructed to stand on the affected or operated leg while reaching out as far as possible in one of the three directions with the other lower extremity, and then return that leg to the center. The participant will be asked to perform the test barefoot, keeping the heel of the stance leg on the floor at all times and to bend the knee of the stance leg. If the participant does not carry out any of these instructions, the trial will repeated.
The assessor will measure the reach distance in each direction in centimeters and then normalize the average of the three trials to leg length.
measure: Physical activity measurements change will be assess using an activPAL activity monitor (PAL Technologies, Glasgow, UK)
time frame: one week before admission day and 6 months after surgery to assess the physical activity changes post-surgery
description: an activPAL activity monitor (PAL Technologies, Glasgow, UK) as this proven accelerometer provides objective quantification of free-living physical activity without any modification (Dahlgren, Carlsson, Moorhead, Hager-Ross, & McDonough, 2010; Schmalzried et al., 1998). It is suitable as it light in weight (20g), includes an inclinometer and is small in size (53 x 35 x 7 mm) Figure 3. The device is worn by patient's mid-thigh, secured by non-allergic waterproof adhesive tape under their clothes, for 7-10 days before surgery and 6 months after. Clear written and verbal instructions will be given to patients as they have to wear it all day and all night except, when bathing or swimming (they can take a shower with it on).
measure: Arabic versions of Oxford Knee Score Validity assessment
time frame: one week before admission day
description: The patients will be instructed to complete the Arabic versions of Oxford Knee Score, Arabic versions of Knee injury and Osteoarthritis Outcome Score (KOOS) and visual analogue scale (VAS) before Arthroplasty as baseline data in order to assess the correlation of Arabic versions of Oxford Knee Score with the Arabic version of KOOS and VAS to determine construct validity (Arabic versions of Oxford Knee Score, Knee injury and Osteoarthritis Outcome Score and visual analogue scale
measure: Arabic versions of Oxford Knee Score Reliability assessment
time frame: one week before admission day, admission day and 6 months after surgery and to evaluate the construct validity of the Arabic version of Oxford Knee Score
description: Patients will be asked to fill out Arabic forms independently without any interpretation to assess the Score reliability and responsiveness.
arm group label: before and after total knee arthroplasty
description: assess the functional outcome before and 6 months after total knee arthroplasty
intervention type: Procedure
intervention name: Total knee arthroplasty
description: prospective assessments for the functional outcome before and after the total knee arthroplasty
arm group label: before and after total knee arthroplasty
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Saudi Arabia
citation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
PMID: 12091180
citation: Bade MJ, Kohrt WM, Stevens-Lapsley JE. Outcomes before and after total knee arthroplasty compared to healthy adults. J Orthop Sports Phys Ther. 2010 Sep;40(9):559-67. doi: 10.2519/jospt.2010.3317.
PMID: 20710093
citation: Bade MJ, Wolfe P, Zeni JA, Stevens-Lapsley JE, Snyder-Mackler L. Predicting poor physical performance after total knee arthroplasty. J Orthop Res. 2012 Nov;30(11):1805-10. doi: 10.1002/jor.22140. Epub 2012 Apr 26.
PMID: 22539338
citation: Bullens PH, van Loon CJ, de Waal Malefijt MC, Laan RF, Veth RP. Patient satisfaction after total knee arthroplasty: a comparison between subjective and objective outcome assessments. J Arthroplasty. 2001 Sep;16(6):740-7. doi: 10.1054/arth.2001.23922.
PMID: 11547372
citation: Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.
PMID: 22398175
citation: Charoencholvanich K, Pongcharoen B. Oxford knee score and SF-36: translation & reliability for use with total knee arthroscopy patients in Thailand. J Med Assoc Thai. 2005 Sep;88(9):1194-202.
PMID: 16536104
citation: Coughlan GF, Fullam K, Delahunt E, Gissane C, Caulfield BM. A comparison between performance on selected directions of the star excursion balance test and the Y balance test. J Athl Train. 2012 Jul-Aug;47(4):366-71. doi: 10.4085/1062-6050-47.4.03.
PMID: 22889651
citation: Dahlgren G, Carlsson D, Moorhead A, Hager-Ross C, McDonough SM. Test-retest reliability of step counts with the ActivPAL device in common daily activities. Gait Posture. 2010 Jul;32(3):386-90. doi: 10.1016/j.gaitpost.2010.06.022. Epub 2010 Jul 22.
PMID: 20655228
citation: Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.
PMID: 23680877
citation: Field, A. (2009). Discovering Statistics Using SPSS: SAGE Publications Ltd,.
citation: Fullam K, Caulfield B, Coughlan GF, Delahunt E. Kinematic analysis of selected reach directions of the Star Excursion Balance Test compared with the Y-Balance Test. J Sport Rehabil. 2014 Feb;23(1):27-35. doi: 10.1123/jsr.2012-0114. Epub 2013 Aug 12.
PMID: 23945793
citation: Gill S, McBurney H. Reliability of performance-based measures in people awaiting joint replacement surgery of the hip or knee. Physiother Res Int. 2008 Sep;13(3):141-52. doi: 10.1002/pri.411.
PMID: 18697226
citation: Gribble PA, Hertel J, Plisky P. Using the Star Excursion Balance Test to assess dynamic postural-control deficits and outcomes in lower extremity injury: a literature and systematic review. J Athl Train. 2012 May-Jun;47(3):339-57. doi: 10.4085/1062-6050-47.3.08.
PMID: 22892416
citation: Harris K, Dawson J, Doll H, Field RE, Murray DW, Fitzpatrick R, Jenkinson C, Price AJ, Beard DJ. Can pain and function be distinguished in the Oxford Knee Score in a meaningful way? An exploratory and confirmatory factor analysis. Qual Life Res. 2013 Nov;22(9):2561-8. doi: 10.1007/s11136-013-0393-x. Epub 2013 Mar 23.
PMID: 23526094
citation: Hertel J, Braham RA, Hale SA, Olmsted-Kramer LC. Simplifying the star excursion balance test: analyses of subjects with and without chronic ankle instability. J Orthop Sports Phys Ther. 2006 Mar;36(3):131-7. doi: 10.2519/jospt.2006.36.3.131.
PMID: 16596889
citation: Hossain FS, Konan S, Patel S, Rodriguez-Merchan EC, Haddad FS. The assessment of outcome after total knee arthroplasty: are we there yet? Bone Joint J. 2015 Jan;97-B(1):3-9. doi: 10.1302/0301-620X.97B1.34434.
PMID: 25568406
citation: Hossain FS, Patel S, Fernandez MA, Konan S, Haddad FS. A performance based patient outcome score for active patients following total knee arthroplasty. Osteoarthritis Cartilage. 2013 Jan;21(1):51-9. doi: 10.1016/j.joca.2012.09.019. Epub 2012 Oct 9.
PMID: 23063619
citation: Hyong IH, Kim JH. Test of intrarater and interrater reliability for the star excursion balance test. J Phys Ther Sci. 2014 Aug;26(8):1139-41. doi: 10.1589/jpts.26.1139. Epub 2014 Aug 30.
PMID: 25202168
citation: Impellizzeri FM, Mannion AF, Leunig M, Bizzini M, Naal FD. Comparison of the reliability, responsiveness, and construct validity of 4 different questionnaires for evaluating outcomes after total knee arthroplasty. J Arthroplasty. 2011 Sep;26(6):861-9. doi: 10.1016/j.arth.2010.07.027. Epub 2010 Nov 12.
PMID: 21074964
citation: Jagger, C., Matthews, R., Spiers, N., Brayne, C., Comas - Herrera, A., Robinson, T., . . . Croft, P. (2006). Compression or expansion of disability?: forecasting future disability levels under changing patterns of diseases: King's Fund.
citation: Jenny JY, Diesinger Y. Validation of a French version of the Oxford knee questionnaire. Orthop Traumatol Surg Res. 2011 May;97(3):267-71. doi: 10.1016/j.otsr.2010.07.009. Epub 2011 Jan 12.
PMID: 21233035
citation: Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord. 2005 Jan 28;6:3. doi: 10.1186/1471-2474-6-3.
PMID: 15679884
citation: Klit J, Jacobsen S, Rosenlund S, Sonne-Holm S, Troelsen A. Total knee arthroplasty in younger patients evaluated by alternative outcome measures. J Arthroplasty. 2014 May;29(5):912-7. doi: 10.1016/j.arth.2013.09.035. Epub 2013 Oct 1.
PMID: 24269097
citation: Ko V, Naylor JM, Harris IA, Crosbie J, Yeo AE. The six-minute walk test is an excellent predictor of functional ambulation after total knee arthroplasty. BMC Musculoskelet Disord. 2013 Apr 24;14:145. doi: 10.1186/1471-2474-14-145.
PMID: 23617377
citation: Lungu E, Desmeules F, Dionne CE, Belzile EL, Vendittoli PA. Prediction of poor outcomes six months following total knee arthroplasty in patients awaiting surgery. BMC Musculoskelet Disord. 2014 Sep 8;15:299. doi: 10.1186/1471-2474-15-299.
PMID: 25201448
citation: Lutzner C, Kirschner S, Lutzner J. Patient activity after TKA depends on patient-specific parameters. Clin Orthop Relat Res. 2014 Dec;472(12):3933-40. doi: 10.1007/s11999-014-3813-5. Epub 2014 Jul 23.
PMID: 25053290
citation: McCambridge J, Witton J, Elbourne DR. Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects. J Clin Epidemiol. 2014 Mar;67(3):267-77. doi: 10.1016/j.jclinepi.2013.08.015. Epub 2013 Nov 22.
PMID: 24275499
citation: Meiring RM, Frimpong E, Mokete L, Pietrzak J, Van Der Jagt D, Tikly M, McVeigh JA. Rationale, design and protocol of a longitudinal study assessing the effect of total knee arthroplasty on habitual physical activity and sedentary behavior in adults with osteoarthritis. BMC Musculoskelet Disord. 2016 Jul 13;17:281. doi: 10.1186/s12891-016-1141-5.
PMID: 27411316
citation: Mizner RL, Petterson SC, Clements KE, Zeni JA Jr, Irrgang JJ, Snyder-Mackler L. Measuring functional improvement after total knee arthroplasty requires both performance-based and patient-report assessments: a longitudinal analysis of outcomes. J Arthroplasty. 2011 Aug;26(5):728-37. doi: 10.1016/j.arth.2010.06.004. Epub 2010 Sep 20.
PMID: 20851566
citation: Naal FD, Impellizzeri FM, Sieverding M, Loibl M, von Knoch F, Mannion AF, Leunig M, Munzinger U. The 12-item Oxford Knee Score: cross-cultural adaptation into German and assessment of its psychometric properties in patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2009 Jan;17(1):49-52. doi: 10.1016/j.joca.2008.05.017. Epub 2008 Jul 7.
PMID: 18602843
citation: Palmer CR. Encyclopedia of biostatistics. BMJ. 1999 Feb 20;318(7182):542. doi: 10.1136/bmj.318.7182.542. No abstract available.
PMID: 10024284
citation: Patel A, Pavlou G, Mujica-Mota RE, Toms AD. The epidemiology of revision total knee and hip arthroplasty in England and Wales: a comparative analysis with projections for the United States. A study using the National Joint Registry dataset. Bone Joint J. 2015 Aug;97-B(8):1076-81. doi: 10.1302/0301-620X.97B8.35170.
PMID: 26224824
citation: Plichta, S., & Kelvin, E. (2012). Munro's Statistical Methods for Health Care Research: Lippincott Williams & Wilkins.
citation: Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
PMID: 1991946
citation: Robinson RH, Gribble PA. Support for a reduction in the number of trials needed for the star excursion balance test. Arch Phys Med Rehabil. 2008 Feb;89(2):364-70. doi: 10.1016/j.apmr.2007.08.139.
PMID: 18226664
citation: Schmalzried TP, Szuszczewicz ES, Northfield MR, Akizuki KH, Frankel RE, Belcher G, Amstutz HC. Quantitative assessment of walking activity after total hip or knee replacement. J Bone Joint Surg Am. 1998 Jan;80(1):54-9.
PMID: 9469309
citation: Stratford PW, Kennedy DM. Performance measures were necessary to obtain a complete picture of osteoarthritic patients. J Clin Epidemiol. 2006 Feb;59(2):160-7. doi: 10.1016/j.jclinepi.2005.07.012. Epub 2005 Dec 27.
PMID: 16426951
citation: Thumboo J, Chew LH, Lewin-Koh SC. Socioeconomic and psychosocial factors influence pain or physical function in Asian patients with knee or hip osteoarthritis. Ann Rheum Dis. 2002 Nov;61(11):1017-20. doi: 10.1136/ard.61.11.1017.
PMID: 12379527
citation: Unver B, Kalkan S, Yuksel E, Kahraman T, Karatosun V. Reliability of the 50-foot walk test and 30-sec chair stand test in total knee arthroplasty. Acta Ortop Bras. 2015 Jul-Aug;23(4):184-7. doi: 10.1590/1413-78522015230401018.
PMID: 26327798
responsible party type: Principal Investigator
investigator affiliation: University of Salford
investigator full name: Bodor Bin sheeha
investigator title: PhD student at University of Salford
sharing ipd: No