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NCT Number: NCT01160835

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Orthopedic Surgery, National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

total knee arthroplastyinstruments

Procedure

Quadriceps-sparing arthrotomy with side-cutting instruments

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Jul 12, 2010
Registry last updated
Jul 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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