Status:
TERMINATED
Comparison of Functional Outcomes of Three Surgical Approaches in Knee Arthroplasty
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-70 years
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 unicompar...
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 ...
Eligibility Criteria
Inclusion
- TKA subjects:
- Patients requiring primary knee arthroplasty;
- Knee osteoarthritis;
- Subject has sufficient quantity or quality of bone support;
- Subject has no previous or active infection in the affected joint or systemic infection;
- Subject judged to be available for follow-up through at least 1 year postoperative;
- All subjects in arthroplasty groups will be between 50-70 years of age
- Healthy subjects:
- Healthy subjects will have no complaints of knee pain or history of knee surgery or known arthritic knee changes.
- All subjects will have no history of prior lower extremity arthroplasty surgeries or systemic disease which could confound outcome measures.
- All healthy persons will be 40-70 years.
Exclusion
- Insufficient quantity or quality of bone support resulting from conditions such as cancer, femoral osteotomy, significant osteoporosis or metabolic disorders of calcified tissues;
- Unable to return for follow up x-rays and clinical evaluation;
- Unable to comprehending study protocol for any reason;
- Systemic inflammatory joint disease (rheumatoid arthritis), previous infection or those requiring revision knee surgery;
- 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;
- Subject has a neurologic condition that would influence the results of biomechanical analysis of whole body movement.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00983762
Start Date
June 1 2009
End Date
January 1 2020
Last Update
November 5 2009
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