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Comparison of Quadriceps-sparing Minimally Invasive and Medial Parapatellar Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT01160835
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : July 12, 2010
Sponsor:
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE July 1, 2010
First Posted Date  ICMJE July 12, 2010
Last Update Posted Date July 12, 2010
Study Start Date  ICMJE May 2005
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2010)
To compare the clinic and functional outcomes of total knee arthroplasty (TKA) respectively through a quadriceps-sparing (QS) approach and a MIS medial parapatellar (MP) approach [ Time Frame: 2 years ]
Perioperative parameters: operative time, blood loss, Doses of narcotics for pain control, peri-operative complications Postoperative parameters: VAS, range of motion, knee functional score, isokinetic studies, radiographic alignment, complications
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2010)
To compare the survival and functional outcomes of total knee arthroplasty (TKA) respectively through a quadriceps-sparing (QS) approach and a MIS medial parapatellar (MP) approach at 2-year follow-up. [ Time Frame: 5 and 10 years ]
Postoperative parameters: VAS, range of motion, knee functional score, isokinetic studies, radiographic alignment and failure rate of knee prothesis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Quadriceps-sparing Minimally Invasive and Medial Parapatellar Total Knee Arthroplasty
Official Title  ICMJE Comparison of Quadriceps-sparing Minimally Invasive and Medial Parapatellar Total Knee Arthroplasty
Brief Summary

Quadriceps-sparing minimally invasive total knee arthroplasty (TKA) with side-cutting instruments has been proposed to limit surgical dissection without compromising the surgical outcome. We conducted a prospective, randomized study to compare the outcomes of quadriceps-sparing TKA with conventional medial parapatellar TKA, with two-year follow-up.

We hypothesize that the quadriceps-sparing arthrotomy would not outperform the conventional medial parapatellar arthrotomy in TKA, in terms of postoperative recovery of quadriceps muscle strength, alignment of the prosthetic knee, and clinical outcome.

Detailed Description Eighty primary TKAs in sixty patients of osteoarthritis constituted this study. Patients were randomly assigned to either quadriceps-sparing (QS, 40 knees) or medial parapatellar (MP, 40 knees) group. All surgeries were designed to set the prosthesis with thefemoral component alignment of 7º valgus and the tibial component alignment perpendicular to tibial shaft. Outcome variables included knee function defined by Hospital for Special Surgery knee score, quadriceps muscle strength measured by isokinetic dynamometer, pain indicated on visual analogue scale, range of motion, and post-operative alignment measured on plain radiograph.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE Procedure: total knee arthroplastyinstruments
Quadriceps-sparing arthrotomy with side-cutting instruments
Study Arms  ICMJE
  • Experimental: Quadriceps-sparing total knee arthroplasty
    Quadriceps-sparing arthrotomy with side-cutting instruments
    Intervention: Procedure: total knee arthroplastyinstruments
  • Active Comparator: Medial parapatellar total knee arthroplasty
    Medial parapatellar arthrotomy with front-cutting instruments
    Intervention: Procedure: total knee arthroplastyinstruments
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2010)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • advanced osteoarthritis with radiograph-evident narrowing of joint gap,
  • with persistent symptoms after conservative treatment for at least 6 months, and
  • patients' intention to receive the prosthetic TKA.

Exclusion Criteria:

  • the knees with excessive deformity of femorotibial angle exceeding 15° varus or 10° valgus,
  • flexion contracture exceeding 15°,
  • active infection involving the knees, or
  • knees received previous surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01160835
Other Study ID Numbers  ICMJE 9561705022
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ching-Chuan Jiang, Professor, Department of Orthopaedic Surgery of National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hongsen Chiang, M.D., Ph.D Department of orthopedic surgery of National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP