Clinical trial NCT01160835: Comparison of Quadriceps-sparing Minimally Invasive and Medial Parapatellar Total Knee Arthroplasty
Official title: Comparison of Quadriceps-sparing Minimally Invasive and Medial Parapatellar Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: total knee arthroplasty
minimally invasive
quadriceps-sparing
Quadriceps-sparing total knee arthroplasty
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-07-12
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 5 and 10 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Orthopedic Surgery, National Taiwan University Hospital
Study officials:
affiliation: Department of orthopedic surgery of National Taiwan University Hospital
name: Hongsen Chiang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: