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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01160835
First received: July 1, 2010
Last updated: July 9, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Procedure: total knee arthroplastyinstruments
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Quadriceps-sparing Minimally Invasive and Medial Parapatellar Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Postoperative parameters: VAS, range of motion, knee functional score, isokinetic studies, radiographic alignment and failure rate of knee prothesis


Enrollment: 80
Study Start Date: May 2005
Study Completion Date: November 2007
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quadriceps-sparing total knee arthroplasty
Quadriceps-sparing arthrotomy with side-cutting instruments
Procedure: total knee arthroplastyinstruments
Quadriceps-sparing arthrotomy with side-cutting instruments
Active Comparator: Medial parapatellar total knee arthroplasty
Medial parapatellar arthrotomy with front-cutting instruments
Procedure: total knee arthroplastyinstruments
Quadriceps-sparing arthrotomy with side-cutting instruments

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.

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160835

Locations
Taiwan
Department of Orthopedic Surgery, National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Hongsen Chiang, M.D., Ph.D Department of orthopedic surgery of National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Ching-Chuan Jiang, Professor, Department of Orthopaedic Surgery of National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01160835     History of Changes
Other Study ID Numbers: 9561705022
Study First Received: July 1, 2010
Last Updated: July 9, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
total knee arthroplasty
minimally invasive
quadriceps-sparing
Quadriceps-sparing total knee arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014