Clinical trial NCT00822640: Comparison of Rotating vs. Fixed Platform of the COLUMBUS Knee Prosthesis
Official title: Clinical Outcome With Attention to Functional Results One Year After Fixed or Mobile Bearing Total Knee Replacement in a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Rheumatoid Arthritis
Post-traumatic; Arthrosis
Keywords: Prosthesis Design
Range of Motion, Articular
Arthroplasty, Replacement, Knee
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Society Score
timeFrame: 12 Months
Secondary outcomes:
measure: Oxford Score
timeFrame: 12
measure: Range of Motion
timeFrame: 12 Months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Frank Lampe, MD
Study officials:
affiliation: Schön Kliniken Klinikum Eilbek
name: Frank Lampe, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Marques CJ, Daniel S, Sufi-Siavach A, Lampe F. No differences in clinical outcomes between fixed- and mobile-bearing computer-assisted total knee arthroplasties and no correlations between navigation data and clinical scores. Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1660-8. doi: 10.1007/s00167-014-3127-x. Epub 2014 Jun 15.