Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty

Not Applicable

• Conditions: Total Knee Arthroplasty
• Interventions: Device: Rotating platform total knee arthroplasty; Device: Fixed bearing total knee arthroplasty

• Registration Number: NCT03731676
• Lead Sponsor: William Hopkinson

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-12-01
• Primary Completion: 2001-12-31
• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-11-02
• Study First Posted: 2018-11-06
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-16
• Last Update Posted: 2021-04-19
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotating platform total knee arthroplasty	Rotating platform total knee arthroplasty	These patients were randomly assigned to receive a rotating platform total knee arthroplasty.
Fixed bearing total knee arthroplasty	Fixed bearing total knee arthroplasty	These patients were randomly assigned to receive a fixed bearing total knee arthroplasty.

Primary Outcome Measures

Name	Time	Method
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.
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)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dr. William Hopkinson; 🇺🇸 Maywood, Illinois, United States