<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/NCT04450485</url>
  </required_header>
  <id_info>
    <org_study_id>2018TIPF017</org_study_id>
    <nct_id>NCT04450485</nct_id>
  </id_info>
  <brief_title>Surgical Approach in Fast Track Knee Arthroplasty</brief_title>
  <official_title>Does Mini Mid-Vastus Approach Have An Advantageous Effect On Rapid Recovery Protocols Over Medial Parapatellar Approach In Total Knee Arthroplasty? A Prospective, Randomized, Single-Blinded Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pamukkale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pamukkale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nowadays, due to the demands to improve life and health conditions of osteoarthritis&#xD;
      patients, more effective surgical treatment methods are needed to obtain satisfactory results&#xD;
      when performing total knee arthroplasty (TKA). Fast-track surgical protocols are evidence&#xD;
      based multidisciplinary approaches targeted on multimodal patient care and primarily focused&#xD;
      on enhancing rapid functional recovery of the patients. These protocols recommend use of&#xD;
      minimal invasive approaches for TKA patients to enhance rapid recovery. Although studies in&#xD;
      the literature has been reported similar results in medial para-patellar approach (MPP) and&#xD;
      minimal invasive approaches in long terms, better surgical outcomes in short term in favor of&#xD;
      minimal invasive approaches also encouraged fast-track protocol builders to prefer minimal&#xD;
      invasive approaches. However, this recommendation is not evidence based and there is no study&#xD;
      comparing surgical outcomes between minimal invasive approaches and MPP approach in terms of&#xD;
      pain, length of hospital stays and functional recovery in fast-track TKA patients. Therefore,&#xD;
      we aimed to compare the effects of mini mid-vastus (MMV) and MPP approaches on postoperative&#xD;
      clinical results (pain, quality of life, functional outcome, and length of hospital stay) in&#xD;
      fast-track TKA patients, and to decide whether any additional achievements are obtained with&#xD;
      MMV approach in this patient group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nowadays, due to the demands to improve life and health conditions of OA patients, more&#xD;
      effective surgical treatment methods are needed to obtain satisfactory results when&#xD;
      performing total knee arthroplasty (TKA). Fast-track surgical protocols are evidence based&#xD;
      multidisciplinary approaches targeted on multimodal patient care and primarily focused on&#xD;
      enhancing rapid functional recovery of the patients. These protocols include patient&#xD;
      education to cope with anxiety and stress of surgery, nutritional planning and avoidance of&#xD;
      long hours of fasting, preemptive analgesia, avoidance of tourniquet use, rational antibiotic&#xD;
      prophylaxis, local infiltration anesthesia, and early physical therapy modalities. The&#xD;
      ultimate aims of assembling these surgical protocols are to decrease mortality and morbidity,&#xD;
      length of hospital stay, and eventually hospital costs while obtaining maximum patient&#xD;
      satisfaction.&#xD;
&#xD;
      Surgical approaches when performing TKA operations includes standard medial parapatellar&#xD;
      (MPP) approach and minimal invasive approaches such as mini midvastus (MMV) and subvastus&#xD;
      (SV) approaches. Possible advantages of not performing quadriceps tendon splitting in MV&#xD;
      surgical approach (such as less pain, earlier functional recovery, enhanced quadriceps muscle&#xD;
      strength, and better ROM) convinced surgeons to prefer minimal invasive approaches to MPP&#xD;
      approach when performing rapid recovery protocols in TKA patients. In addition, better&#xD;
      surgical outcomes with traditional protocols in short term reports in favor of minimal&#xD;
      invasive approaches also encouraged fast-track protocol builders to prefer minimal invasive&#xD;
      approaches. However, these recommendations are not evidence based and, to our knowledge,&#xD;
      there is no study comparing surgical outcomes between minimal invasive approaches and MPP&#xD;
      approach in terms of pain, length of hospital stay and functional recovery in fast-track TKA&#xD;
      patients. Therefore, we aimed to compare the effects of MMV and MPP approaches on&#xD;
      postoperative clinical results (pain, quality of life, functional outcome, and length of&#xD;
      hospital stay) in fast-track TKA patients, and to decide whether any additional achievements&#xD;
      are obtained with MMV approach in this patient group. Our secondary outcome measures were&#xD;
      length of operation time, blood loss and postoperative component alignments.&#xD;
&#xD;
      Clinical and demographic variables of the participants were recorded and patients were&#xD;
      evaluated preoperatively, at postoperative fourth and twelfth week by a blinded observer.&#xD;
      Knee range of motion was assessed with digital goniometer (HALO Medical Devices, Australia);&#xD;
      quadriceps muscle strength was measured (unit=newton(N)) with hand-held dynamometer&#xD;
      (Commander Muscle Tester, J Tech, USA); The Western Ontario and McMaster Universities&#xD;
      Arthritis Index (WOMAC) and Knee injury and Osteoarthritis Outcome Score (KOOS) was used to&#xD;
      determine patient-reported activity limitations; 30-sec chair-stand test and stair-climb test&#xD;
      were performed for performance-based activity limitations; Short Form-36 (SF-36) was used for&#xD;
      quality of life evaluations.&#xD;
&#xD;
      Alignment analysis Long leg radiographs of the patients were evaluated preoperatively and&#xD;
      postoperatively by using a digital orthopedic templating software-Materialise OrthoView&#xD;
      (OrthoView version 7, Materialise HQ, Technologielaan 15 3001 Leuven, Belgium).&#xD;
      Hip-knee-ankle angles (HKA), femorotibial angles, lateral proximal femoral angles (LPFA),&#xD;
      lateral distal femoral angles (LDFA), medial proximal tibial angles (MPTA), lateral distal&#xD;
      tibial angles (LDTA), tibial posterior slope angles were all measured and recorded by a&#xD;
      blinded observer.&#xD;
&#xD;
      Preoperative patient education classes All the patients were received preoperative&#xD;
      informative classes about TKA procedure, nutritional and nursing support, physical therapy&#xD;
      and rehabilitation applications. Booklets concerning all these classes were also handed out&#xD;
      to all patients.&#xD;
&#xD;
      Anesthesia Protocol Excluding diabetics, all the patients were received oral carbohydrate&#xD;
      (%12.5 carbohydrate liquid solution-Fantomalt, Nutricia) loading on the night before the&#xD;
      operation (between 19:00 and 23:00) and 2 hours before the operation. Solid foods were&#xD;
      allowed up to 6 hours before the operation and liquids allowed up to 2 hours preoperatively.&#xD;
      Early oral feeding was started at 4 to 6 hours postoperatively for all patients. Intravenous&#xD;
      midazolam 1-2 mg and fentanyl 50-100 μg were applied to all patients 30-45 minutes&#xD;
      preoperatively. Except 12 patients, all patients received spinal anesthesia. Seven patients&#xD;
      due to previous lumber fusion and 5 patients due to personal preference were received general&#xD;
      anesthesia.&#xD;
&#xD;
      Surgical Technique All the operations were performed by the same surgeon using the same brand&#xD;
      and type of prosthesis. MPP and MMV approaches were performed as described in the literature.&#xD;
      All the patients received posterior stabilized fixed bearing TKA (NexGen Legacy® Posterior&#xD;
      Stabilized Knee-Fixed Bearing, Zimmer-Biomet Inc., Warsaw, Indiana 46580, ABD), and high&#xD;
      viscosity polymethyl methacrylate (PMMA) bone cement (Oliga-G21 srl-Vias. Pertini, 8-41039&#xD;
      San Posidonia (MO)-Italy). All the operations were performed without using tourniquet.&#xD;
&#xD;
      Local infiltration anesthesia (LIA) (20 cc bupivacaine hydrochloride, 1 gr fentanyl, 1 gr&#xD;
      cefazolin sodium, 0.3 ml epinephrine, and dilute volume of physiologic serum (%0,9 NaCl) to&#xD;
      50 cc) to posterior capsule just before the application of permanent implants, and to&#xD;
      anterior capsule, prepatellar fat pad and peri ligamentous nociceptive receptors following&#xD;
      consolidation of bone cement was injected.&#xD;
&#xD;
      One gram of tranexamic acid was injected intravenously (iv) at least 30 minutes before the&#xD;
      incision, 1 gr diluted to 30 cc by physiologic serum (%0,9 NaCl) was given intraarticularly&#xD;
      following the closure of the wound, and another 1 gr was infused 2 hours after the operation.&#xD;
&#xD;
      Preoperative and postoperative analgesia protocol For preemptive analgesia, paracetamol 500&#xD;
      mg tablets were prescribed 3 times 2 tablets per day beginning from 3 days before the&#xD;
      operation. One gram of iv infusion of paracetamol was given just after the operation in&#xD;
      postoperative care unit and continued as 3 times 1gr iv infusion. First line rescue analgesic&#xD;
      was intramuscular 75 mg diclofenac sodium and second line analgesic was iv 100 mg tramadol&#xD;
      hydrochloride.&#xD;
&#xD;
      Antibiotic and thrombosis prophylaxis protocol One gr of cefazolin sodium iv was applied 30&#xD;
      minutes before the incision as antibiotic prophylaxis. Low molecular weight&#xD;
      heparin-enoxaparin sodium 4000 iu/0.8 ml/day was used subcutaneously as thromboembolic&#xD;
      prophylaxis starting at the 6-8 hours postoperatively and continued for 20 days.&#xD;
&#xD;
      Rehabilitation protocol and discharge criteria The patients were mobilized at the 4th hour&#xD;
      following surgery and standard physiotherapy program was scheduled during hospitalization&#xD;
      (cold-pack -once in every 2 hours for 15 minutes, ankle pump exercises, quadriceps isometric&#xD;
      exercises, active assisted heel slide exercises in bed and knee flexion exercises in sitting&#xD;
      position/3 sets×10 repeats). The patients were evaluated regularly every two hours during&#xD;
      postoperative period and those fulfilling discharge criteria were released from the hospital&#xD;
      and length of hospital stay was recorded for every patient. The standard discharge criteria&#xD;
      were as follows: VAS score at rest &lt;3, VAS score during mobilization &lt;5, able to get dressed&#xD;
      independently, able to get in and out of bed, able to sit and rise from a chair/toilet seat,&#xD;
      independence in personal care, mobilization with walker/crutches, able to walk &gt;70 meters&#xD;
      without risk of fall with walking aid, no incision problem.&#xD;
&#xD;
      The discharged patients were instructed for a standard home-based exercise program. Patients&#xD;
      were also asked to visit the ward at a biweekly interval for the update of the exercise&#xD;
      program for the first 8 weeks. 15-40 minutes of walking exercises were also prescribed for 5&#xD;
      days/week between 9th and 12th weeks.&#xD;
&#xD;
      Statistical analysis Priori power analysis concerning quadriceps muscle strength showed that&#xD;
      at an effect size of d=0.7, 52 patients are needed (26 patients for each group) to obtain 80&#xD;
      % power (1-beta=0.80) with 95 % confidence interval (alpha=0.05).&#xD;
&#xD;
      The data was analyzed using SPSS 24.0 (IBM Corp. Released 2016. IBM SPSS Statistics for&#xD;
      Windows, Version 24.0. Armonk, NY: IBM Corp.) package program. Continuous variables were&#xD;
      given as mean ± standard deviation, median (minimum and maximum) and categorical variable&#xD;
      values were presented as absolute numbers and percentages. The conformity of continuous&#xD;
      variables with normal distribution was evaluated using the Shapiro-Wilk test. Independent&#xD;
      Samples t-test for parametric test assumptions and Mann-Whitney U Test for non-parametric&#xD;
      test assumptions were used for comparison of the groups. One-way repeated-measure ANOVA was&#xD;
      used to compare the normally distributed data from the parameters repeatedly measured in the&#xD;
      inner-group analysis, and Friedman analysis of variance was performed for the remaining data&#xD;
      set. Statistical significance was set at p ≤ 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients planned for fast track protocol applied total knee arthroplasty randomized into two groups by a computer program to generate random numbers and assign participants to either to mini mid-vastus or medial para-patellar surgical approach group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Patients and outcomes assessor are blinded to the type of surgical approach.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain preoperative</measure>
    <time_frame>Baseline (preoperatively)</time_frame>
    <description>Visual Analog Scale used to assess pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain postoperative 1</measure>
    <time_frame>at postoperative fourth weeks</time_frame>
    <description>Visual Analog Scale used to assess pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain postoperative 2</measure>
    <time_frame>at postoperative twelfth weeks</time_frame>
    <description>Visual Analog Scale used to assess pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Range of Motion preoperative</measure>
    <time_frame>Baseline (preoperatively)</time_frame>
    <description>Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Range of Motion postoperative 1</measure>
    <time_frame>at postoperative fourth week</time_frame>
    <description>Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Range of Motion postoperative 2</measure>
    <time_frame>at postoperative twelfth week</time_frame>
    <description>Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quadriceps muscle strength preoperative</measure>
    <time_frame>Baseline (preoperatively)</time_frame>
    <description>Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quadriceps muscle strength postoperative 1</measure>
    <time_frame>at postoperative fourth weeks</time_frame>
    <description>Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quadriceps muscle strength postoperative 2</measure>
    <time_frame>at postoperative twelfth weeks</time_frame>
    <description>Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-reported activity limitations preoperative</measure>
    <time_frame>Baseline (preoperatively)</time_frame>
    <description>The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-reported activity limitations postoperative 1</measure>
    <time_frame>at postoperative fourth weeks</time_frame>
    <description>The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-reported activity limitations postoperative 2</measure>
    <time_frame>at postoperative twelfth weeks</time_frame>
    <description>The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance-based activity limitations-preoperative</measure>
    <time_frame>Baseline (preoperatively)</time_frame>
    <description>30-sec chair-stand test and stair-climb test are used</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance-based activity limitations- postoperative 1</measure>
    <time_frame>at postoperative fourth weeks</time_frame>
    <description>30-sec chair-stand test and stair-climb test are used</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance-based activity limitations - postoperative 2</measure>
    <time_frame>at postoperative twelfth weeks</time_frame>
    <description>30-sec chair-stand test and stair-climb test are used</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life-preoperative</measure>
    <time_frame>Baseline (preoperatively)</time_frame>
    <description>Short Form-36 (SF-36) is used</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life-preoperative- postoperative 1</measure>
    <time_frame>at postoperative fourth weeks</time_frame>
    <description>Short Form-36 (SF-36) is used</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life-preoperative- postoperative 2</measure>
    <time_frame>at postoperative twelfth weeks</time_frame>
    <description>Short Form-36 (SF-36) is used</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Length of hospital stay is measured beginning from the hospitalization of the patient and ending at discharge of the patients (unit-hours)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of operation time</measure>
    <time_frame>the surgery</time_frame>
    <description>Length of operation time is measured in minutes during the surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of blood loss</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Amount of blood loss is measured from the suction drainage (unit-milliliters)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative component alignments</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Long leg radiographs of the patients are evaluated postoperatively by using a digital orthopedic templating software-Materialise OrthoView (OrthoView version 7, Materialise HQ, Technologielaan 15 3001 Leuven, Belgium).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Knee Arthroplasty, Total</condition>
  <arm_group>
    <arm_group_label>Medial para-patellar approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fast track protocol applied total knee arthroplasty patients operated by using medial para-patellar approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mini mid-vastus approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fast track protocol applied total knee arthroplasty patients operated by using mini mid-vastus approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total knee arthroplasty</intervention_name>
    <description>Total knee arthroplasty</description>
    <arm_group_label>Medial para-patellar approach</arm_group_label>
    <arm_group_label>Mini mid-vastus approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for unilateral TKA surgery due to primary OA&#xD;
&#xD;
          -  Patients capable of understanding verbal and written instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Revision TKA surgery&#xD;
&#xD;
          -  ASA score &gt;3&#xD;
&#xD;
          -  previous major orthopedic surgery in either lower extremities&#xD;
&#xD;
          -  neurologic compromise&#xD;
&#xD;
          -  psychiatric problems&#xD;
&#xD;
          -  regular hypnotic and/or anxiolytic medication usage&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  patients participated in a particular physical activity program within the last 3&#xD;
             months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harun R Gungor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pamukkale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pamukkale University Medical Faculty</name>
      <address>
        <city>Denizli</city>
        <zip>20070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Husted H. Fast-track hip and knee arthroplasty: clinical and organizational aspects. Acta Orthop Suppl. 2012 Oct;83(346):1-39. doi: 10.3109/17453674.2012.700593.</citation>
    <PMID>23205862</PMID>
  </reference>
  <reference>
    <citation>Stowers MD, Manuopangai L, Hill AG, Gray JR, Coleman B, Munro JT. Enhanced Recovery After Surgery in elective hip and knee arthroplasty reduces length of hospital stay. ANZ J Surg. 2016 Jun;86(6):475-9. doi: 10.1111/ans.13538. Epub 2016 Mar 28.</citation>
    <PMID>27018137</PMID>
  </reference>
  <reference>
    <citation>Heekin RD, Fokin AA. Mini-midvastus versus mini-medial parapatellar approach for minimally invasive total knee arthroplasty: outcomes pendulum is at equilibrium. J Arthroplasty. 2014 Feb;29(2):339-42. doi: 10.1016/j.arth.2013.05.016. Epub 2013 Jun 19.</citation>
    <PMID>23790343</PMID>
  </reference>
  <reference>
    <citation>Karpman RR, Smith HL. Comparison of the early results of minimally invasive vs standard approaches to total knee arthroplasty: a prospective, randomized study. J Arthroplasty. 2009 Aug;24(5):681-8. doi: 10.1016/j.arth.2008.03.011. Epub 2008 Jun 6.</citation>
    <PMID>18538536</PMID>
  </reference>
  <reference>
    <citation>Chin PL, Foo LS, Yang KY, Yeo SJ, Lo NN. Randomized controlled trial comparing the radiologic outcomes of conventional and minimally invasive techniques for total knee arthroplasty. J Arthroplasty. 2007 Sep;22(6):800-6. doi: 10.1016/j.arth.2006.10.009. Epub 2007 Apr 20.</citation>
    <PMID>17826268</PMID>
  </reference>
  <reference>
    <citation>Dalury DF, Jiranek WA. A comparison of the midvastus and paramedian approaches for total knee arthroplasty. J Arthroplasty. 1999 Jan;14(1):33-7. doi: 10.1016/s0883-5403(99)90199-7.</citation>
    <PMID>9926950</PMID>
  </reference>
  <reference>
    <citation>White RE Jr, Allman JK, Trauger JA, Dales BH. Clinical comparison of the midvastus and medial parapatellar surgical approaches. Clin Orthop Relat Res. 1999 Oct;(367):117-22.</citation>
    <PMID>10546605</PMID>
  </reference>
  <reference>
    <citation>Stevens-Lapsley JE, Bade MJ, Shulman BC, Kohrt WM, Dayton MR. Minimally invasive total knee arthroplasty improves early knee strength but not functional performance: a randomized controlled trial. J Arthroplasty. 2012 Dec;27(10):1812-1819.e2. doi: 10.1016/j.arth.2012.02.016. Epub 2012 Mar 28.</citation>
    <PMID>22459124</PMID>
  </reference>
  <reference>
    <citation>Lin WP, Lin J, Horng LC, Chang SM, Jiang CC. Quadriceps-sparing, minimal-incision total knee arthroplasty: a comparative study. J Arthroplasty. 2009 Oct;24(7):1024-32. doi: 10.1016/j.arth.2008.07.005. Epub 2008 Aug 30.</citation>
    <PMID>18757172</PMID>
  </reference>
  <reference>
    <citation>Nestor BJ, Toulson CE, Backus SI, Lyman SL, Foote KL, Windsor RE. Mini-midvastus vs standard medial parapatellar approach: a prospective, randomized, double-blinded study in patients undergoing bilateral total knee arthroplasty. J Arthroplasty. 2010 Sep;25(6 Suppl):5-11, 11.e1. doi: 10.1016/j.arth.2010.04.003. Epub 2010 Jun 11.</citation>
    <PMID>20541889</PMID>
  </reference>
  <reference>
    <citation>Kazarian GS, Siow MY, Chen AF, Deirmengian CA. Comparison of Quadriceps-Sparing and Medial Parapatellar Approaches in Total Knee Arthroplasty: A Meta-Analysis of Randomized Controlled Trials. J Arthroplasty. 2018 Jan;33(1):277-283. doi: 10.1016/j.arth.2017.08.025. Epub 2017 Aug 30.</citation>
    <PMID>28947369</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pamukkale University</investigator_affiliation>
    <investigator_full_name>Harun Resit Gungor</investigator_full_name>
    <investigator_title>MD, Associated Professor</investigator_title>
  </responsible_party>
  <keyword>Total knee arthroplasty; Surgical approach; Fast track</keyword>
  <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/NCT04450485
org study id: 2018TIPF017
nct id: NCT04450485
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nowadays, due to the demands to improve life and health conditions of osteoarthritis
      patients, more effective surgical treatment methods are needed to obtain satisfactory results
      when performing total knee arthroplasty (TKA). Fast-track surgical protocols are evidence
      based multidisciplinary approaches targeted on multimodal patient care and primarily focused
      on enhancing rapid functional recovery of the patients. These protocols recommend use of
      minimal invasive approaches for TKA patients to enhance rapid recovery. Although studies in
      the literature has been reported similar results in medial para-patellar approach (MPP) and
      minimal invasive approaches in long terms, better surgical outcomes in short term in favor of
      minimal invasive approaches also encouraged fast-track protocol builders to prefer minimal
      invasive approaches. However, this recommendation is not evidence based and there is no study
      comparing surgical outcomes between minimal invasive approaches and MPP approach in terms of
      pain, length of hospital stays and functional recovery in fast-track TKA patients. Therefore,
      we aimed to compare the effects of mini mid-vastus (MMV) and MPP approaches on postoperative
      clinical results (pain, quality of life, functional outcome, and length of hospital stay) in
      fast-track TKA patients, and to decide whether any additional achievements are obtained with
      MMV approach in this patient group.
Nowadays, due to the demands to improve life and health conditions of OA patients, more
      effective surgical treatment methods are needed to obtain satisfactory results when
      performing total knee arthroplasty (TKA). Fast-track surgical protocols are evidence based
      multidisciplinary approaches targeted on multimodal patient care and primarily focused on
      enhancing rapid functional recovery of the patients. These protocols include patient
      education to cope with anxiety and stress of surgery, nutritional planning and avoidance of
      long hours of fasting, preemptive analgesia, avoidance of tourniquet use, rational antibiotic
      prophylaxis, local infiltration anesthesia, and early physical therapy modalities. The
      ultimate aims of assembling these surgical protocols are to decrease mortality and morbidity,
      length of hospital stay, and eventually hospital costs while obtaining maximum patient
      satisfaction.

      Surgical approaches when performing TKA operations includes standard medial parapatellar
      (MPP) approach and minimal invasive approaches such as mini midvastus (MMV) and subvastus
      (SV) approaches. Possible advantages of not performing quadriceps tendon splitting in MV
      surgical approach (such as less pain, earlier functional recovery, enhanced quadriceps muscle
      strength, and better ROM) convinced surgeons to prefer minimal invasive approaches to MPP
      approach when performing rapid recovery protocols in TKA patients. In addition, better
      surgical outcomes with traditional protocols in short term reports in favor of minimal
      invasive approaches also encouraged fast-track protocol builders to prefer minimal invasive
      approaches. However, these recommendations are not evidence based and, to our knowledge,
      there is no study comparing surgical outcomes between minimal invasive approaches and MPP
      approach in terms of pain, length of hospital stay and functional recovery in fast-track TKA
      patients. Therefore, we aimed to compare the effects of MMV and MPP approaches on
      postoperative clinical results (pain, quality of life, functional outcome, and length of
      hospital stay) in fast-track TKA patients, and to decide whether any additional achievements
      are obtained with MMV approach in this patient group. Our secondary outcome measures were
      length of operation time, blood loss and postoperative component alignments.

      Clinical and demographic variables of the participants were recorded and patients were
      evaluated preoperatively, at postoperative fourth and twelfth week by a blinded observer.
      Knee range of motion was assessed with digital goniometer (HALO Medical Devices, Australia);
      quadriceps muscle strength was measured (unit=newton(N)) with hand-held dynamometer
      (Commander Muscle Tester, J Tech, USA); The Western Ontario and McMaster Universities
      Arthritis Index (WOMAC) and Knee injury and Osteoarthritis Outcome Score (KOOS) was used to
      determine patient-reported activity limitations; 30-sec chair-stand test and stair-climb test
      were performed for performance-based activity limitations; Short Form-36 (SF-36) was used for
      quality of life evaluations.

      Alignment analysis Long leg radiographs of the patients were evaluated preoperatively and
      postoperatively by using a digital orthopedic templating software-Materialise OrthoView
      (OrthoView version 7, Materialise HQ, Technologielaan 15 3001 Leuven, Belgium).
      Hip-knee-ankle angles (HKA), femorotibial angles, lateral proximal femoral angles (LPFA),
      lateral distal femoral angles (LDFA), medial proximal tibial angles (MPTA), lateral distal
      tibial angles (LDTA), tibial posterior slope angles were all measured and recorded by a
      blinded observer.

      Preoperative patient education classes All the patients were received preoperative
      informative classes about TKA procedure, nutritional and nursing support, physical therapy
      and rehabilitation applications. Booklets concerning all these classes were also handed out
      to all patients.

      Anesthesia Protocol Excluding diabetics, all the patients were received oral carbohydrate
      (%12.5 carbohydrate liquid solution-Fantomalt, Nutricia) loading on the night before the
      operation (between 19:00 and 23:00) and 2 hours before the operation. Solid foods were
      allowed up to 6 hours before the operation and liquids allowed up to 2 hours preoperatively.
      Early oral feeding was started at 4 to 6 hours postoperatively for all patients. Intravenous
      midazolam 1-2 mg and fentanyl 50-100 μg were applied to all patients 30-45 minutes
      preoperatively. Except 12 patients, all patients received spinal anesthesia. Seven patients
      due to previous lumber fusion and 5 patients due to personal preference were received general
      anesthesia.

      Surgical Technique All the operations were performed by the same surgeon using the same brand
      and type of prosthesis. MPP and MMV approaches were performed as described in the literature.
      All the patients received posterior stabilized fixed bearing TKA (NexGen Legacy® Posterior
      Stabilized Knee-Fixed Bearing, Zimmer-Biomet Inc., Warsaw, Indiana 46580, ABD), and high
      viscosity polymethyl methacrylate (PMMA) bone cement (Oliga-G21 srl-Vias. Pertini, 8-41039
      San Posidonia (MO)-Italy). All the operations were performed without using tourniquet.

      Local infiltration anesthesia (LIA) (20 cc bupivacaine hydrochloride, 1 gr fentanyl, 1 gr
      cefazolin sodium, 0.3 ml epinephrine, and dilute volume of physiologic serum (%0,9 NaCl) to
      50 cc) to posterior capsule just before the application of permanent implants, and to
      anterior capsule, prepatellar fat pad and peri ligamentous nociceptive receptors following
      consolidation of bone cement was injected.

      One gram of tranexamic acid was injected intravenously (iv) at least 30 minutes before the
      incision, 1 gr diluted to 30 cc by physiologic serum (%0,9 NaCl) was given intraarticularly
      following the closure of the wound, and another 1 gr was infused 2 hours after the operation.

      Preoperative and postoperative analgesia protocol For preemptive analgesia, paracetamol 500
      mg tablets were prescribed 3 times 2 tablets per day beginning from 3 days before the
      operation. One gram of iv infusion of paracetamol was given just after the operation in
      postoperative care unit and continued as 3 times 1gr iv infusion. First line rescue analgesic
      was intramuscular 75 mg diclofenac sodium and second line analgesic was iv 100 mg tramadol
      hydrochloride.

      Antibiotic and thrombosis prophylaxis protocol One gr of cefazolin sodium iv was applied 30
      minutes before the incision as antibiotic prophylaxis. Low molecular weight
      heparin-enoxaparin sodium 4000 iu/0.8 ml/day was used subcutaneously as thromboembolic
      prophylaxis starting at the 6-8 hours postoperatively and continued for 20 days.

      Rehabilitation protocol and discharge criteria The patients were mobilized at the 4th hour
      following surgery and standard physiotherapy program was scheduled during hospitalization
      (cold-pack -once in every 2 hours for 15 minutes, ankle pump exercises, quadriceps isometric
      exercises, active assisted heel slide exercises in bed and knee flexion exercises in sitting
      position/3 sets×10 repeats). The patients were evaluated regularly every two hours during
      postoperative period and those fulfilling discharge criteria were released from the hospital
      and length of hospital stay was recorded for every patient. The standard discharge criteria
      were as follows: VAS score at rest <3, VAS score during mobilization <5, able to get dressed
      independently, able to get in and out of bed, able to sit and rise from a chair/toilet seat,
      independence in personal care, mobilization with walker/crutches, able to walk >70 meters
      without risk of fall with walking aid, no incision problem.

      The discharged patients were instructed for a standard home-based exercise program. Patients
      were also asked to visit the ward at a biweekly interval for the update of the exercise
      program for the first 8 weeks. 15-40 minutes of walking exercises were also prescribed for 5
      days/week between 9th and 12th weeks.

      Statistical analysis Priori power analysis concerning quadriceps muscle strength showed that
      at an effect size of d=0.7, 52 patients are needed (26 patients for each group) to obtain 80
      % power (1-beta=0.80) with 95 % confidence interval (alpha=0.05).

      The data was analyzed using SPSS 24.0 (IBM Corp. Released 2016. IBM SPSS Statistics for
      Windows, Version 24.0. Armonk, NY: IBM Corp.) package program. Continuous variables were
      given as mean ± standard deviation, median (minimum and maximum) and categorical variable
      values were presented as absolute numbers and percentages. The conformity of continuous
      variables with normal distribution was evaluated using the Shapiro-Wilk test. Independent
      Samples t-test for parametric test assumptions and Mann-Whitney U Test for non-parametric
      test assumptions were used for comparison of the groups. One-way repeated-measure ANOVA was
      used to compare the normally distributed data from the parameters repeatedly measured in the
      inner-group analysis, and Friedman analysis of variance was performed for the remaining data
      set. Statistical significance was set at p ≤ 0.05.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients planned for fast track protocol applied total knee arthroplasty randomized into two groups by a computer program to generate random numbers and assign participants to either to mini mid-vastus or medial para-patellar surgical approach group
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Patients and outcomes assessor are blinded to the type of surgical approach.
measure: Pain preoperative
time frame: Baseline (preoperatively)
description: Visual Analog Scale used to assess pain
measure: Pain postoperative 1
time frame: at postoperative fourth weeks
description: Visual Analog Scale used to assess pain
measure: Pain postoperative 2
time frame: at postoperative twelfth weeks
description: Visual Analog Scale used to assess pain
measure: Knee Range of Motion preoperative
time frame: Baseline (preoperatively)
description: Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion
measure: Knee Range of Motion postoperative 1
time frame: at postoperative fourth week
description: Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion
measure: Knee Range of Motion postoperative 2
time frame: at postoperative twelfth week
description: Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion
measure: Quadriceps muscle strength preoperative
time frame: Baseline (preoperatively)
description: Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA)
measure: Quadriceps muscle strength postoperative 1
time frame: at postoperative fourth weeks
description: Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA)
measure: Quadriceps muscle strength postoperative 2
time frame: at postoperative twelfth weeks
description: Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA)
measure: Patient-reported activity limitations preoperative
time frame: Baseline (preoperatively)
description: The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used
measure: Patient-reported activity limitations postoperative 1
time frame: at postoperative fourth weeks
description: The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used
measure: Patient-reported activity limitations postoperative 2
time frame: at postoperative twelfth weeks
description: The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used
measure: Performance-based activity limitations-preoperative
time frame: Baseline (preoperatively)
description: 30-sec chair-stand test and stair-climb test are used
measure: Performance-based activity limitations- postoperative 1
time frame: at postoperative fourth weeks
description: 30-sec chair-stand test and stair-climb test are used
measure: Performance-based activity limitations - postoperative 2
time frame: at postoperative twelfth weeks
description: 30-sec chair-stand test and stair-climb test are used
measure: Quality of life-preoperative
time frame: Baseline (preoperatively)
description: Short Form-36 (SF-36) is used
measure: Quality of life-preoperative- postoperative 1
time frame: at postoperative fourth weeks
description: Short Form-36 (SF-36) is used
measure: Quality of life-preoperative- postoperative 2
time frame: at postoperative twelfth weeks
description: Short Form-36 (SF-36) is used
measure: Length of hospital stay
time frame: through study completion, an average of 1 year
description: Length of hospital stay is measured beginning from the hospitalization of the patient and ending at discharge of the patients (unit-hours)
measure: Length of operation time
time frame: the surgery
description: Length of operation time is measured in minutes during the surgery
measure: Amount of blood loss
time frame: through study completion, an average of 1 year
description: Amount of blood loss is measured from the suction drainage (unit-milliliters)
measure: postoperative component alignments
time frame: through study completion, an average of 1 year
description: Long leg radiographs of the patients are evaluated postoperatively by using a digital orthopedic templating software-Materialise OrthoView (OrthoView version 7, Materialise HQ, Technologielaan 15 3001 Leuven, Belgium).
arm group label: Medial para-patellar approach
arm group type: Active Comparator
description: Fast track protocol applied total knee arthroplasty patients operated by using medial para-patellar approach
arm group label: Mini mid-vastus approach
arm group type: Active Comparator
description: Fast track protocol applied total knee arthroplasty patients operated by using mini mid-vastus approach
intervention type: Procedure
intervention name: Total knee arthroplasty
description: Total knee arthroplasty
arm group label: Medial para-patellar approach
arm group label: Mini mid-vastus approach
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Harun R Gungor, MD
role: Principal Investigator
affiliation: Pamukkale University
facility: 
country: Turkey
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PMID: 23205862
citation: Stowers MD, Manuopangai L, Hill AG, Gray JR, Coleman B, Munro JT. Enhanced Recovery After Surgery in elective hip and knee arthroplasty reduces length of hospital stay. ANZ J Surg. 2016 Jun;86(6):475-9. doi: 10.1111/ans.13538. Epub 2016 Mar 28.
PMID: 27018137
citation: Heekin RD, Fokin AA. Mini-midvastus versus mini-medial parapatellar approach for minimally invasive total knee arthroplasty: outcomes pendulum is at equilibrium. J Arthroplasty. 2014 Feb;29(2):339-42. doi: 10.1016/j.arth.2013.05.016. Epub 2013 Jun 19.
PMID: 23790343
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PMID: 18538536
citation: Chin PL, Foo LS, Yang KY, Yeo SJ, Lo NN. Randomized controlled trial comparing the radiologic outcomes of conventional and minimally invasive techniques for total knee arthroplasty. J Arthroplasty. 2007 Sep;22(6):800-6. doi: 10.1016/j.arth.2006.10.009. Epub 2007 Apr 20.
PMID: 17826268
citation: Dalury DF, Jiranek WA. A comparison of the midvastus and paramedian approaches for total knee arthroplasty. J Arthroplasty. 1999 Jan;14(1):33-7. doi: 10.1016/s0883-5403(99)90199-7.
PMID: 9926950
citation: White RE Jr, Allman JK, Trauger JA, Dales BH. Clinical comparison of the midvastus and medial parapatellar surgical approaches. Clin Orthop Relat Res. 1999 Oct;(367):117-22.
PMID: 10546605
citation: Stevens-Lapsley JE, Bade MJ, Shulman BC, Kohrt WM, Dayton MR. Minimally invasive total knee arthroplasty improves early knee strength but not functional performance: a randomized controlled trial. J Arthroplasty. 2012 Dec;27(10):1812-1819.e2. doi: 10.1016/j.arth.2012.02.016. Epub 2012 Mar 28.
PMID: 22459124
citation: Lin WP, Lin J, Horng LC, Chang SM, Jiang CC. Quadriceps-sparing, minimal-incision total knee arthroplasty: a comparative study. J Arthroplasty. 2009 Oct;24(7):1024-32. doi: 10.1016/j.arth.2008.07.005. Epub 2008 Aug 30.
PMID: 18757172
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PMID: 20541889
citation: Kazarian GS, Siow MY, Chen AF, Deirmengian CA. Comparison of Quadriceps-Sparing and Medial Parapatellar Approaches in Total Knee Arthroplasty: A Meta-Analysis of Randomized Controlled Trials. J Arthroplasty. 2018 Jan;33(1):277-283. doi: 10.1016/j.arth.2017.08.025. Epub 2017 Aug 30.
PMID: 28947369
responsible party type: Principal Investigator
investigator affiliation: Pamukkale University
investigator full name: Harun Resit Gungor
investigator title: MD, Associated Professor
sharing ipd: No