Total Knee Arthroplasty Clinical Trial
Official title:
Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty
Verified date | April 2021 |
Source | Loyola University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients were randomly assigned to a fixed bearing or rotating platform of two prostheses. A subsequent study (the one retrospectively registering the original study) asked these patients a series of questions from published questionnaires to assess long term outcomes.
Status | Active, not recruiting |
Enrollment | 250 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2001 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Osteoarthritis 2. Rheumatoid or other inflammatory arthritis 3. Post-traumatic arthritis 4. Juvenile rheumatoid arthritis 5. Avascular necrosis Exclusion Criteria: 1. History of recent/active joint sepsis 2. Charcot neuropathy 3. Psycho-social disorders that would limit rehabilitation 4. Metabolic disorders of calcified tissues, such as Paget's disease 5. Joint replacement due to autoimmune disorders 6. Skeletal immaturity 7. Ligamentous laxity requiring a constrained prosthesis |
Country | Name | City | State |
---|---|---|---|
United States | Dr. William Hopkinson | Maywood | Illinois |
Lead Sponsor | Collaborator |
---|---|
William Hopkinson |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Functional Status over time | Knee Society Clinical Rating Scale | Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20. | |
Primary | Change in Osteoarthritis Status over time | Western Ontario and McMaster University Osteoarthritis Index (WOMAC)- A 24 item questionnaire to assess pain, stiffness, and physical function in patients with hip or knee osteoarthritis divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical function (17 items) | Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20. | |
Primary | Change in Overall Health Status over time | Medical Outcomes Study Short Form -36 Health Survey (SF-36)- A 36 item questionnaire to assess overall health. | Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20. | |
Secondary | Change in Satisfaction of Knee over time | 4-point Likert scale used to assess satisfaction with knee Scale-1. Extremely satisfied 2. Satisfied 3. Unsatisfied 4. Extremely unsatisfied | Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20. |
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