Comparison of Rotating vs. Fixed Platform of the COLUMBUS Knee Prosthesis

Study Overview
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Brief Summary
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A population of 100 patients randomised to rotating and fixed PE inlays in the Columbus knee prosthesis received a navigated TKR. Knee Society Score as primary endpoint, Oxford Score, and postoperative ROM after one year will be compared.

Detailed Description
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Mobile bearing tibial platform designs are advocated to improve functional results of total knee replacement (TKR), and to reduce wear in the longer term. This study investigates short term functional results with two patient groups who are systematically different in the fixed or mobile tibial bearing only. Methods: 100 knees in 97 patients are stratified according to age and gender and randomized into two groups fixed bearing (FB) with 52 knees and mobile bearing (MB) with 48 knees. All receive the same posterior cruciate retaining implant but the tibial tray and bearing (B. Braun Aesculap Columbus CR and RP) by two experienced surgeons and follow an identical rehabilitation regime. Physical examinations are performed in a double-blinded manner before the operation and three, six and twelve months thereafter, using the Oxford and Knee Society scoring systems.

Official Title
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Clinical Outcome With Attention to Functional Results One Year After Fixed or Mobile Bearing Total Knee Replacement in a Randomized Controlled Trial

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Post-traumatic; Arthrosis

Intervention / Treatment
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* Device: Total Knee Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for elective TKA agreement to participate in this study Patient age between 40 and 90 years Exclusion Criteria: Malalignment of the knee to be operated of more than 20° varus or 15° valgus Former operations on the concerned knee (except diagnostic or therapeutic arthroscopy with only meniscus refixation or cartilage smoothing) Joint replacement of another joint of the same leg Infections in the operated joint during the follow-up period Thromboses during the follow-up period Preoperative classification according to ASA 4, 5 or 6

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Columbus Knee Prosthesis with rotating Platform | Device: Total Knee Arthroplasty<br>* All patients receive the same posterior cruciate retaining implant but the tibial tray and bearing (B. Braun Aesculap Columbus CR and RP) by two experienced surgeons and will follow an identical rehabilitation regime.<br>* Other names: Columbus Knee Prosthesis;|
| Active Comparator: 2<br>Columbus Knee Prosthesis with fixed platform | Device: Total Knee Arthroplasty<br>* All patients receive the same posterior cruciate retaining implant but the tibial tray and bearing (B. Braun Aesculap Columbus CR and RP) by two experienced surgeons and will follow an identical rehabilitation regime.<br>* Other names: Columbus Knee Prosthesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Score |  | 12 | 
| Range of Motion |  | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prosthesis Design, Range of Motion, Articular, Arthroplasty, Replacement, Knee