Total Knee Arthroplasty
Conditions
Brief summary
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.
Interventions
DEVICEFixed bearing total knee arthroplasty
Fixed bearing total knee arthroplasty
DEVICERotating platform total knee arthroplasty
Rotating platform total knee arthroplasty
Sponsors
William Hopkinson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Status over time | 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. | Knee Society Clinical Rating Scale |
| Change in Osteoarthritis Status over time | 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. | 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) |
| Change in Overall Health Status over time | 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. | Medical Outcomes Study Short Form -36 Health Survey (SF-36)- A 36 item questionnaire to assess overall health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Satisfaction of Knee over time | 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. | 4-point Likert scale used to assess satisfaction with knee Scale-1. Extremely satisfied 2. Satisfied 3. Unsatisfied 4. Extremely unsatisfied |
Countries
United States
Outcome results
None listed