Comparison of Functional Outcomes of Three Surgical Approaches in Knee Arthroplasty

NCT ID: NCT00983762

Last Updated: 2009-11-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2020-01-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

MIS knee arthroplasty

Persons scheduled for Minimally Invasive Surgery Mini-Incision (MIS) Total Knee Arthroplasty (TKA)

No interventions assigned to this group

Unicompartmental knee arthroplasty

Persons scheduled for Unicompartmental knee arthroplasty

No interventions assigned to this group

Standard knee arthroplasty

Persons scheduled for Standard Para-patellar surgery TKA

No interventions assigned to this group

Heathly knee subjects

Persons with healthy knees

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Massachusetts General Hospital

Principal Investigators

Henrik Malchau, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Other Identifiers

2007P001220

Identifier Type: -

Identifier Source: org_study_id