Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty

NCT03731676 | Unknown FDA Device

• 1 other identifier: 11119
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (1)

• 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 Arms (2)

Rotating platform total knee arthroplasty

ACTIVE COMPARATOR

These patients were randomly assigned to receive a rotating platform total knee arthroplasty.

Device: Rotating platform total knee arthroplasty

Fixed bearing total knee arthroplasty

ACTIVE COMPARATOR

These patients were randomly assigned to receive a fixed bearing total knee arthroplasty.

Device: Fixed bearing total knee arthroplasty

Interventions

Fixed bearing total knee arthroplasty DEVICE

Fixed bearing total knee arthroplasty

Fixed bearing total knee arthroplasty

Rotating platform total knee arthroplasty DEVICE

Rotating platform total knee arthroplasty

Rotating platform total knee arthroplasty

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• William Hopkinson: lead

Study Sites (1)

Dr. William Hopkinson

Maywood, Illinois, 60153, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Vice Chairman of Orthopaedic Surgery and Rehabilitation

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: November 6, 2018
• Study Start: December 1, 2000
• Primary Completion: December 31, 2001
• Study Completion: December 31, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)