Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty

April 16, 2021 updated by: William Hopkinson
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Dr. William Hopkinson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Rotating platform total knee arthroplasty
These patients were randomly assigned to receive a rotating platform total knee arthroplasty.
Device: Rotating platform total knee arthroplasty
Rotating platform total knee arthroplasty
ACTIVE_COMPARATOR: Fixed bearing total knee arthroplasty
These patients were randomly assigned to receive a fixed bearing total knee arthroplasty.
Device: Fixed bearing total knee arthroplasty
Fixed bearing total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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)
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Satisfaction of Knee 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Hopkinson

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2000

Primary Completion (ACTUAL)

December 31, 2001

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

October 16, 2018

First Submitted That Met QC Criteria

November 2, 2018

First Posted (ACTUAL)

November 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 11119 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results in a general basis via a manuscript. No individual data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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