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

NCT ID: NCT01160835

Last Updated: 2010-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-11-30

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Quadriceps-sparing total knee arthroplasty

Quadriceps-sparing arthrotomy with side-cutting instruments

Group Type EXPERIMENTAL

total knee arthroplastyinstruments

Intervention Type PROCEDURE

Quadriceps-sparing arthrotomy with side-cutting instruments

Medial parapatellar total knee arthroplasty

Medial parapatellar arthrotomy with front-cutting instruments

Group Type ACTIVE_COMPARATOR

total knee arthroplastyinstruments

Intervention Type PROCEDURE

Quadriceps-sparing arthrotomy with side-cutting instruments

Interventions

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total knee arthroplastyinstruments

Quadriceps-sparing arthrotomy with side-cutting instruments

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Orthopaedic Surgery of National Taiwan University Hospital

Principal Investigators

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Hongsen Chiang, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of orthopedic surgery of National Taiwan University Hospital

Locations

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Department of Orthopedic Surgery, National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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9561705022

Identifier Type: -

Identifier Source: org_study_id

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