Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty

NCT ID: NCT03731676

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-01

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rotating platform total knee arthroplasty

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

Group Type ACTIVE_COMPARATOR

Rotating platform total knee arthroplasty

Intervention Type DEVICE

Rotating platform total knee arthroplasty

Fixed bearing total knee arthroplasty

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

Group Type ACTIVE_COMPARATOR

Fixed bearing total knee arthroplasty

Intervention Type DEVICE

Fixed bearing total knee arthroplasty

Interventions

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Fixed bearing total knee arthroplasty

Fixed bearing total knee arthroplasty

Intervention Type DEVICE

Rotating platform total knee arthroplasty

Rotating platform total knee arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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William Hopkinson

OTHER

Sponsor Role lead

Responsible Party

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William Hopkinson

Professor, Vice Chairman of Orthopaedic Surgery and Rehabilitation

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Dr. William Hopkinson

Maywood, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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11119

Identifier Type: -

Identifier Source: org_study_id

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