<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/NCT01696552</url>
  </required_header>
  <id_info>
    <org_study_id>2011/7613</org_study_id>
    <secondary_id>2010/2056</secondary_id>
    <nct_id>NCT01696552</nct_id>
  </id_info>
  <brief_title>Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty</brief_title>
  <official_title>Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty - a Prospective Randomized Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Betanien Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sykehuset Telemark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vestre Viken Hospital Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Prospective, randomized, clinical controlled study comparing conventional knee arthroplasty&#xD;
      and the Patient-specific positioning guides (PSPG) (Signature Patient Care, Materialise)&#xD;
      using the Vanguard Total Knee System (Biomet)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Use of PSPG in TKR is a relative new technique and already widely used. PSPG,&#xD;
      based on MRI data, fit directly into the patient's anatomy and enable total knee replacement&#xD;
      without use of traditional invasive instrumentation. Data showing extra benefit of this&#xD;
      technique compared to conventional TKR technique are not widely available.&#xD;
&#xD;
      Aim: To determine the safety of this new surgical technique compared to conventional TKR and&#xD;
      whether a clinical, functional and financial benefit can be achieved.&#xD;
&#xD;
      Methods: 200 patients with primary osteoarthritis will be randomized to 2 groups. 30 patients&#xD;
      in each group will be included in the RSA section of the study. Participating hospitals UOS&#xD;
      Ullevål, Vestre Viken, Sykehuset Telemark and Betanien Hospital Skien. Inclusion started Aug.&#xD;
      2011. Clinical scoring: KSS, KOOS, EQ-5D and VAS will be examined at inclusion, after 3&#xD;
      months, and at the 1 and 2 year control. RSA before discharge on day 2, 3 months, 1 year, 2&#xD;
      years. RSA images will be sent blinded to CIRRO (Center for Implant and Radiostereometric&#xD;
      Research Oslo Orthopaedic Centre, Oslo University Hospital) for image analysis. Standing HKA:&#xD;
      preoperatively and after 3 months. X-ray will be taken pre-operatively, postoperative day 3,&#xD;
      after 3 months and after 5 and 10 years. CT Perth after 3 months for measuring alignment. A&#xD;
      cost-benefit analysis will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Actual">January 2014</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessing total knee implant positioning using PSPG compared with the conventional method in TKR</measure>
    <time_frame>3 months</time_frame>
    <description>Measurement of knee implant positioning by using the CT Perth protocol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Functional Result</measure>
    <time_frame>2 yrs</time_frame>
    <description>KOOS (Knee injury and Osteoarthritis Outcome Score), American knee society score, EQ-5D and pain score (NRS) will be registered pre-operatively, after 3 months and after 1 and 2 years. Scores of the 2 groups will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operating Time</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Component Stability</measure>
    <time_frame>2 yrs</time_frame>
    <description>RSA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost to Benefit from a Health Economic Perspective</measure>
    <time_frame>1 year</time_frame>
    <description>Cost-benefit analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>X-ray analysis</measure>
    <time_frame>10 yrs</time_frame>
    <description>Standing HKA (Hip, Knee, Ankle-long axis images): preoperatively and after 3 months. If there is a extension deficit a X-HKA will be performed 12 months postoperatively.&#xD;
X-ray front, side and patella 'sky view' will be taken pre-operatively, postoperative day 3, after 5 and 10 years. Alignment and possible osteolytic development will be recorded in both groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative Morbidity</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">109</enrollment>
  <condition>Gonarthritis</condition>
  <arm_group>
    <arm_group_label>TKR with Positioning Guides (PSPG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of PSPG (Signature, Materialise) in TKR (Vanguard Total Knee System, Biomet)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TKR with Conventional Technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TKR (Vanguard Total Knee System, Biomet), Conventional Technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TKR with Positioning Guides (PSPG)</intervention_name>
    <description>TKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique</description>
    <arm_group_label>TKR with Positioning Guides (PSPG)</arm_group_label>
    <other_name>Vanguard Total Knee System, Biomet</other_name>
    <other_name>Signature, Materialise</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TKR with Conventional Technique</intervention_name>
    <description>TKR (Vanguard Total Knee System, Biomet) with Conventional Technique</description>
    <arm_group_label>TKR with Conventional Technique</arm_group_label>
    <other_name>Vanguard Total Knee System, Biomet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Man and women elder than 18 years old with knee osteoarthritis&#xD;
&#xD;
          2. Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active infection.&#xD;
&#xD;
          2. Under 50 years.&#xD;
&#xD;
          3. Revision arthroplasty.&#xD;
&#xD;
          4. Marked bone loss which could preclude adequate fixation of the device.&#xD;
&#xD;
          5. Non-cooperative subjects.&#xD;
&#xD;
          6. Parkinson's Disease or other neurologic and muscular disorders&#xD;
&#xD;
          7. Severe vascular insufficiency of the affected limb.&#xD;
&#xD;
          8. Severe instability or deformity of the ligaments and / or surrounding soft tissue&#xD;
             which may preclude stability of the device.&#xD;
&#xD;
          9. Paget's disease&#xD;
&#xD;
         10. Rheumatoid Arthritis and other systemic diseases&#xD;
&#xD;
         11. Patients with rigid hip joints&#xD;
&#xD;
         12. Known metal allergy&#xD;
&#xD;
         13. Patients can only join the study with 1 operated knee arthroplasty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephan M Röhrl, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo Univerity Hospital, Oslo, Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Justin van Leeuwen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Betanien Hospital Skien, Skien, Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bjarne Grøgaard, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital, Oslo, Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Finnur Snorrason, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vestre Viken HF, Drammen Hospital, Drammen, Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hilde Apold, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sykehuset Telemark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vestre Viken HF</name>
      <address>
        <city>Drammen</city>
        <state>Buskerud</state>
        <zip>3004</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Implant and Radiostereometric Research Oslo, Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <state>Olso</state>
        <zip>0407</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehuset Telemark</name>
      <address>
        <city>Skien</city>
        <state>Telemark</state>
        <zip>3710</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Betanien Hospital Skien</name>
      <address>
        <city>Skien</city>
        <state>Telemark</state>
        <zip>3722</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>http://ous-research.no/cirro/?k=cirro%2FKnee+projects&amp;aid=12521</url>
    <description>Study description on website: Center for Implant and Radiostereometric Research Oslo - Oslo University Hospital</description>
  </link>
  <reference>
    <citation>Valstar ER, Gill R, Ryd L, Flivik G, Borlin N, Karrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005 Aug;76(4):563-72. doi: 10.1080/17453670510041574.</citation>
    <PMID>16195075</PMID>
  </reference>
  <reference>
    <citation>Ritter MA, Faris PM, Keating EM, Meding JB. Postoperative alignment of total knee replacement. Its effect on survival. Clin Orthop Relat Res. 1994 Feb;(299):153-6.</citation>
    <PMID>8119010</PMID>
  </reference>
  <reference>
    <citation>Chauhan SK, Clark GW, Lloyd S, Scott RG, Breidahl W, Sikorski JM. Computer-assisted total knee replacement. A controlled cadaver study using a multi-parameter quantitative CT assessment of alignment (the Perth CT Protocol). J Bone Joint Surg Br. 2004 Aug;86(6):818-23. doi: 10.1302/0301-620x.86b6.15456.</citation>
    <PMID>15330021</PMID>
  </reference>
  <reference>
    <citation>Klatt BA, Goyal N, Austin MS, Hozack WJ. Custom-fit total knee arthroplasty (OtisKnee) results in malalignment. J Arthroplasty. 2008 Jan;23(1):26-9. doi: 10.1016/j.arth.2007.10.001.</citation>
    <PMID>18165024</PMID>
  </reference>
  <reference>
    <citation>Fehring TK, Odum S, Griffin WL, Mason JB, Nadaud M. Early failures in total knee arthroplasty. Clin Orthop Relat Res. 2001 Nov;(392):315-8. doi: 10.1097/00003086-200111000-00041.</citation>
    <PMID>11716402</PMID>
  </reference>
  <reference>
    <citation>Ng VY, DeClaire JH, Berend KR, Gulick BC, Lombardi AV Jr. Improved accuracy of alignment with patient-specific positioning guides compared with manual instrumentation in TKA. Clin Orthop Relat Res. 2012 Jan;470(1):99-107. doi: 10.1007/s11999-011-1996-6.</citation>
    <PMID>21809150</PMID>
  </reference>
  <reference>
    <citation>Karrholm J, Borssen B, Lowenhielm G, Snorrason F. Does early micromotion of femoral stem prostheses matter? 4-7-year stereoradiographic follow-up of 84 cemented prostheses. J Bone Joint Surg Br. 1994 Nov;76(6):912-7.</citation>
    <PMID>7983118</PMID>
  </reference>
  <reference>
    <citation>Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br. 1995 May;77(3):377-83.</citation>
    <PMID>7744919</PMID>
  </reference>
  <reference>
    <citation>Matziolis G, Krocker D, Weiss U, Tohtz S, Perka C. A prospective, randomized study of computer-assisted and conventional total knee arthroplasty. Three-dimensional evaluation of implant alignment and rotation. J Bone Joint Surg Am. 2007 Feb;89(2):236-43. doi: 10.2106/JBJS.F.00386.</citation>
    <PMID>17272435</PMID>
  </reference>
  <reference>
    <citation>Siston RA, Patel JJ, Goodman SB, Delp SL, Giori NJ. The variability of femoral rotational alignment in total knee arthroplasty. J Bone Joint Surg Am. 2005 Oct;87(10):2276-80. doi: 10.2106/JBJS.D.02945.</citation>
    <PMID>16203894</PMID>
  </reference>
  <reference>
    <citation>Lutzner J, Krummenauer F, Wolf C, Gunther KP, Kirschner S. Computer-assisted and conventional total knee replacement: a comparative, prospective, randomised study with radiological and CT evaluation. J Bone Joint Surg Br. 2008 Aug;90(8):1039-44. doi: 10.1302/0301-620X.90B8.20553.</citation>
    <PMID>18669959</PMID>
  </reference>
  <reference>
    <citation>Weinrauch P, Myers N, Wilkinson M, Dodsworth J, Fitzpatrick P, Whitehouse S. Comparison of early postoperative rehabilitation outcome following total knee arthroplasty using different surgical approaches and instrumentation. J Orthop Surg (Hong Kong). 2006 Apr;14(1):47-52. doi: 10.1177/230949900601400111.</citation>
    <PMID>16598087</PMID>
  </reference>
  <reference>
    <citation>Kalairajah Y, Simpson D, Cossey AJ, Verrall GM, Spriggins AJ. Blood loss after total knee replacement: effects of computer-assisted surgery. J Bone Joint Surg Br. 2005 Nov;87(11):1480-2. doi: 10.1302/0301-620X.87B11.16474.</citation>
    <PMID>16260662</PMID>
  </reference>
  <reference>
    <citation>Victor J, Van Doninck D, Labey L, Innocenti B, Parizel PM, Bellemans J. How precise can bony landmarks be determined on a CT scan of the knee? Knee. 2009 Oct;16(5):358-65. doi: 10.1016/j.knee.2009.01.001. Epub 2009 Feb 5.</citation>
    <PMID>19195896</PMID>
  </reference>
  <reference>
    <citation>Henckel J, Richards R, Lozhkin K, Harris S, Rodriguez y Baena FM, Barrett AR, Cobb JP. Very low-dose computed tomography for planning and outcome measurement in knee replacement. The imperial knee protocol. J Bone Joint Surg Br. 2006 Nov;88(11):1513-8. doi: 10.1302/0301-620X.88B11.17986.</citation>
    <PMID>17075100</PMID>
  </reference>
  <reference>
    <citation>Kim S. Changes in surgical loads and economic burden of hip and knee replacements in the US: 1997-2004. Arthritis Rheum. 2008 Apr 15;59(4):481-8. doi: 10.1002/art.23525.</citation>
    <PMID>18383407</PMID>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>March 27, 2017</last_update_submitted>
  <last_update_submitted_qc>March 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Stephan M Rohrl</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Gonarthritis</keyword>
  <keyword>TKR</keyword>
  <keyword>Conventional</keyword>
  <keyword>Positioning Guides</keyword>
  <keyword>PSPG</keyword>
  <keyword>CT Perth</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cimetidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT01696552
org study id: 2011/7613
secondary id: 2010/2056
nct id: NCT01696552
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
A Prospective, randomized, clinical controlled study comparing conventional knee arthroplasty
      and the Patient-specific positioning guides (PSPG) (Signature Patient Care, Materialise)
      using the Vanguard Total Knee System (Biomet)
Background: Use of PSPG in TKR is a relative new technique and already widely used. PSPG,
      based on MRI data, fit directly into the patient's anatomy and enable total knee replacement
      without use of traditional invasive instrumentation. Data showing extra benefit of this
      technique compared to conventional TKR technique are not widely available.

      Aim: To determine the safety of this new surgical technique compared to conventional TKR and
      whether a clinical, functional and financial benefit can be achieved.

      Methods: 200 patients with primary osteoarthritis will be randomized to 2 groups. 30 patients
      in each group will be included in the RSA section of the study. Participating hospitals UOS
      Ullevål, Vestre Viken, Sykehuset Telemark and Betanien Hospital Skien. Inclusion started Aug.
      2011. Clinical scoring: KSS, KOOS, EQ-5D and VAS will be examined at inclusion, after 3
      months, and at the 1 and 2 year control. RSA before discharge on day 2, 3 months, 1 year, 2
      years. RSA images will be sent blinded to CIRRO (Center for Implant and Radiostereometric
      Research Oslo Orthopaedic Centre, Oslo University Hospital) for image analysis. Standing HKA:
      preoperatively and after 3 months. X-ray will be taken pre-operatively, postoperative day 3,
      after 3 months and after 5 and 10 years. CT Perth after 3 months for measuring alignment. A
      cost-benefit analysis will be performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Assessing total knee implant positioning using PSPG compared with the conventional method in TKR
time frame: 3 months
description: Measurement of knee implant positioning by using the CT Perth protocol
measure: Clinical Functional Result
time frame: 2 yrs
description: KOOS (Knee injury and Osteoarthritis Outcome Score), American knee society score, EQ-5D and pain score (NRS) will be registered pre-operatively, after 3 months and after 1 and 2 years. Scores of the 2 groups will be compared.
measure: Operating Time
time frame: 1 day
measure: Component Stability
time frame: 2 yrs
description: RSA
measure: Cost to Benefit from a Health Economic Perspective
time frame: 1 year
description: Cost-benefit analysis
measure: X-ray analysis
time frame: 10 yrs
description: Standing HKA (Hip, Knee, Ankle-long axis images): preoperatively and after 3 months. If there is a extension deficit a X-HKA will be performed 12 months postoperatively.
X-ray front, side and patella 'sky view' will be taken pre-operatively, postoperative day 3, after 5 and 10 years. Alignment and possible osteolytic development will be recorded in both groups.
measure: Perioperative Morbidity
time frame: 1 week
arm group label: TKR with Positioning Guides (PSPG)
arm group type: Active Comparator
description: Use of PSPG (Signature, Materialise) in TKR (Vanguard Total Knee System, Biomet)
arm group label: TKR with Conventional Technique
arm group type: Active Comparator
description: TKR (Vanguard Total Knee System, Biomet), Conventional Technique
intervention type: Procedure
intervention name: TKR with Positioning Guides (PSPG)
description: TKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique
arm group label: TKR with Positioning Guides (PSPG)
other name: Vanguard Total Knee System, Biomet
other name: Signature, Materialise
intervention type: Procedure
intervention name: TKR with Conventional Technique
description: TKR (Vanguard Total Knee System, Biomet) with Conventional Technique
arm group label: TKR with Conventional Technique
other name: Vanguard Total Knee System, Biomet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephan M Röhrl, MD, PhD
role: Principal Investigator
affiliation: Oslo Univerity Hospital, Oslo, Norway
last name: Justin van Leeuwen, MD
role: Principal Investigator
affiliation: Betanien Hospital Skien, Skien, Norway
last name: Bjarne Grøgaard, MD, PhD
role: Principal Investigator
affiliation: Oslo University Hospital, Oslo, Norway
last name: Finnur Snorrason, MD, PhD
role: Principal Investigator
affiliation: Vestre Viken HF, Drammen Hospital, Drammen, Norway
last name: Hilde Apold, MD, PhD
role: Principal Investigator
affiliation: Sykehuset Telemark
facility: 
facility: 
facility: 
facility: 
country: Norway
url: http://ous-research.no/cirro/?k=cirro%2FKnee+projects&aid=12521
description: Study description on website: Center for Implant and Radiostereometric Research Oslo - Oslo University Hospital
citation: Valstar ER, Gill R, Ryd L, Flivik G, Borlin N, Karrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005 Aug;76(4):563-72. doi: 10.1080/17453670510041574.
PMID: 16195075
citation: Ritter MA, Faris PM, Keating EM, Meding JB. Postoperative alignment of total knee replacement. Its effect on survival. Clin Orthop Relat Res. 1994 Feb;(299):153-6.
PMID: 8119010
citation: Chauhan SK, Clark GW, Lloyd S, Scott RG, Breidahl W, Sikorski JM. Computer-assisted total knee replacement. A controlled cadaver study using a multi-parameter quantitative CT assessment of alignment (the Perth CT Protocol). J Bone Joint Surg Br. 2004 Aug;86(6):818-23. doi: 10.1302/0301-620x.86b6.15456.
PMID: 15330021
citation: Klatt BA, Goyal N, Austin MS, Hozack WJ. Custom-fit total knee arthroplasty (OtisKnee) results in malalignment. J Arthroplasty. 2008 Jan;23(1):26-9. doi: 10.1016/j.arth.2007.10.001.
PMID: 18165024
citation: Fehring TK, Odum S, Griffin WL, Mason JB, Nadaud M. Early failures in total knee arthroplasty. Clin Orthop Relat Res. 2001 Nov;(392):315-8. doi: 10.1097/00003086-200111000-00041.
PMID: 11716402
citation: Ng VY, DeClaire JH, Berend KR, Gulick BC, Lombardi AV Jr. Improved accuracy of alignment with patient-specific positioning guides compared with manual instrumentation in TKA. Clin Orthop Relat Res. 2012 Jan;470(1):99-107. doi: 10.1007/s11999-011-1996-6.
PMID: 21809150
citation: Karrholm J, Borssen B, Lowenhielm G, Snorrason F. Does early micromotion of femoral stem prostheses matter? 4-7-year stereoradiographic follow-up of 84 cemented prostheses. J Bone Joint Surg Br. 1994 Nov;76(6):912-7.
PMID: 7983118
citation: Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br. 1995 May;77(3):377-83.
PMID: 7744919
citation: Matziolis G, Krocker D, Weiss U, Tohtz S, Perka C. A prospective, randomized study of computer-assisted and conventional total knee arthroplasty. Three-dimensional evaluation of implant alignment and rotation. J Bone Joint Surg Am. 2007 Feb;89(2):236-43. doi: 10.2106/JBJS.F.00386.
PMID: 17272435
citation: Siston RA, Patel JJ, Goodman SB, Delp SL, Giori NJ. The variability of femoral rotational alignment in total knee arthroplasty. J Bone Joint Surg Am. 2005 Oct;87(10):2276-80. doi: 10.2106/JBJS.D.02945.
PMID: 16203894
citation: Lutzner J, Krummenauer F, Wolf C, Gunther KP, Kirschner S. Computer-assisted and conventional total knee replacement: a comparative, prospective, randomised study with radiological and CT evaluation. J Bone Joint Surg Br. 2008 Aug;90(8):1039-44. doi: 10.1302/0301-620X.90B8.20553.
PMID: 18669959
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responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Stephan M Rohrl
investigator title: Principal Investigator
mesh term: Cimetidine
sharing ipd: Undecided