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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00822640

Enrollment

100

Registered

2009-01-14

Start date

2004-03-31

Completion date

2008-07-31

Last updated

2013-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Post-traumatic; Arthrosis, Rheumatoid Arthritis

Keywords

Prosthesis Design, Range of Motion, Articular, Arthroplasty, Replacement, Knee

Brief summary

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

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.

Interventions

DEVICETotal Knee Arthroplasty

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Knee Society Score	12 Months

Secondary

Measure	Time frame
Oxford Score	12
Range of Motion	12 Months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026