Comparison of Functional Outcomes of Three Surgical Approaches in Knee Arthroplasty

Terminated

• Conditions: Knee Osteoarthritis

• Registration Number: NCT00983762
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

A functional outcomes comparison study of three surgical techniques using minimally invasive surgery mini-incision (MIS) for total knee arthroplasty (TKA), standard para-patellar TKA and the unicompartmental knee arthroplasty performed over a 2+ year post-op period.

Detailed Description

The purpose of this research study is to compare post-operative knee function of persons who have undergone one of three types of knee arthroplasty for the treatment of knee osteoarthritis. A variety of functional performance tests will be assessed and compared using a group of evaluations including: functional activity performance tests and questionnaires; leg strength; knee range of motion; and forces at the knee during a series of activities (walking, bending, stepping etc.) via a motion analysis system. The study will compare the three surgical subject groups and one group of healthy, non-surgical subjects for a total of 100 subjects.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-23
• Study First Posted: 2009-09-24
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-04
• Last Update Posted: 2009-11-05
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• TKA subjects:

  1. Patients requiring primary knee arthroplasty;
  2. Knee osteoarthritis;
  3. Subject has sufficient quantity or quality of bone support;
  4. Subject has no previous or active infection in the affected joint or systemic infection;
  5. Subject judged to be available for follow-up through at least 1 year postoperative;
  6. All subjects in arthroplasty groups will be between 50-70 years of age

• Healthy subjects:

  1. Healthy subjects will have no complaints of knee pain or history of knee surgery or known arthritic knee changes.
  2. All subjects will have no history of prior lower extremity arthroplasty surgeries or systemic disease which could confound outcome measures.
  3. All healthy persons will be 40-70 years.

Exclusion Criteria

1. Insufficient quantity or quality of bone support resulting from conditions such as cancer, femoral osteotomy, significant osteoporosis or metabolic disorders of calcified tissues;
2. Unable to return for follow up x-rays and clinical evaluation;
3. Unable to comprehending study protocol for any reason;
4. Systemic inflammatory joint disease (rheumatoid arthritis), previous infection or those requiring revision knee surgery;
5. Subject has an immunological disorder: immunosuppressive treatment characterized by markedly inhibited ability to respond to antigenic stimuli. Examples of such conditions include Subjects who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), Subjects receiving therapy to prevent homograft rejection, Subjects who have a documented history of acquired immunodeficiency syndrome (AIDS), or auto-immune diseases;
6. Subject has a neurologic condition that would influence the results of biomechanical analysis of whole body movement.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Isokinetic and isometric quadriceps and hamstring strength	Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years

Secondary Outcome Measures

Name	Time	Method
American Academy Orthopaedic Surgeons Knee Score	Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Knee loading pattern during gait & chair rise	Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
University California Los Angeles Activity Score	Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)	Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Knee adductor moment during gait and chair rise	Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Visual Analog Pain Scale	Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Sit to Stand to Sit (STSTS) Test	Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Timed "Up & Go" Test	Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Stair Test	Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years