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Clinical Trials/NCT03731676
NCT03731676
Unknown
Not Applicable

Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty

William Hopkinson1 site in 1 country250 target enrollmentDecember 1, 2000

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Knee Arthroplasty
Sponsor
William Hopkinson
Enrollment
250
Locations
1
Primary Endpoint
Change in Overall Health Status over time
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2000
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
William Hopkinson
Responsible Party
Sponsor Investigator
Principal Investigator

William Hopkinson

Professor, Vice Chairman of Orthopaedic Surgery and Rehabilitation

Loyola University

Eligibility Criteria

Inclusion Criteria

  • Osteoarthritis
  • Rheumatoid or other inflammatory arthritis
  • Post-traumatic arthritis
  • Juvenile rheumatoid arthritis
  • Avascular necrosis

Exclusion Criteria

  • History of recent/active joint sepsis
  • Charcot neuropathy
  • Psycho-social disorders that would limit rehabilitation
  • Metabolic disorders of calcified tissues, such as Paget's disease
  • Joint replacement due to autoimmune disorders
  • Skeletal immaturity
  • Ligamentous laxity requiring a constrained prosthesis

Outcomes

Primary Outcomes

Change in Overall Health Status over time

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • 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.)

Study Sites (1)

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