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

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: total knee arthroplastyinstruments

• Registration Number: NCT01160835
• Lead Sponsor: National Taiwan University Hospital

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 Timeline

• Study Start: 2005-05
• Primary Completion: 2006-02
• Study Completion: 2007-11
• Status Verified: 2010-06
• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-09
• Last Update Submitted: 2010-07-09
• Study First Posted: 2010-07-12
• Last Update Posted: 2010-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadriceps-sparing total knee arthroplasty	total knee arthroplastyinstruments	Quadriceps-sparing arthrotomy with side-cutting instruments
Medial parapatellar total knee arthroplasty	total knee arthroplastyinstruments	Medial parapatellar arthrotomy with front-cutting instruments

Primary Outcome Measures

Name	Time	Method
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	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

Secondary Outcome Measures

Name	Time	Method
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.	5 and 10 years	Postoperative parameters: VAS, range of motion, knee functional score, isokinetic studies, radiographic alignment and failure rate of knee prothesis

Trial Locations

Locations (1)

Department of Orthopedic Surgery, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan