Comparison of Rotating vs. Fixed Platform of the COLUMBUS Knee Prosthesis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Columbus Knee Prosthesis with rotating Platform |
Device: Total 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.
Other Names:
|
| Active Comparator: 2 Columbus Knee Prosthesis with fixed platform |
Device: Total 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Knee Society Score [12 Months]
Secondary Outcome Measures
- Oxford Score [12]
- Range of Motion [12 Months]
Eligibility Criteria
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)
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Joint replacement of another joint of the same leg
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Infections in the operated joint during the follow-up period
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Thromboses during the follow-up period
-
Preoperative classification according to ASA 4, 5 or 6
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Frank Lampe, MD | Hamburg | Germany | 22081 |
Sponsors and Collaborators
- Aesculap AG
Investigators
- Principal Investigator: Frank Lampe, MD, Schön Kliniken Klinikum Eilbek
Study Documents (Full-Text)
None provided.More Information
Publications
- Buechel FF Sr, Buechel FF Jr, Pappas MJ, D'Alessio J. Twenty-year evaluation of meniscal bearing and rotating platform knee replacements. Clin Orthop Relat Res. 2001 Jul;(388):41-50.
- Buechel FF Sr. Long-term followup after mobile-bearing total knee replacement. Clin Orthop Relat Res. 2002 Nov;(404):40-50.
- Callaghan JJ, Insall JN, Greenwald AS, Dennis DA, Komistek RD, Murray DW, Bourne RB, Rorabeck CH, Dorr LD. Mobile-bearing knee replacement: concepts and results. Instr Course Lect. 2001;50:431-49. Review.
- Callaghan JJ, Squire MW, Goetz DD, Sullivan PM, Johnston RC. Cemented rotating-platform total knee replacement. A nine to twelve-year follow-up study. J Bone Joint Surg Am. 2000 May;82(5):705-11.
- Callaghan JJ. Mobile-bearing knee replacement: clinical results: a review of the literature. Clin Orthop Relat Res. 2001 Nov;(392):221-5. Review.
- Catani F, Benedetti MG, De Felice R, Buzzi R, Giannini S, Aglietti P. Mobile and fixed bearing total knee prosthesis functional comparison during stair climbing. Clin Biomech (Bristol, Avon). 2003 Jun;18(5):410-8.
- Chiu KY, Ng TP, Tang WM, Lam P. Bilateral total knee arthroplasty: One mobile-bearing and one fixed-bearing. J Orthop Surg (Hong Kong). 2001 Jun;9(1):45-50.
- Emerson RH Jr, Hansborough T, Reitman RD, Rosenfeldt W, Higgins LL. Comparison of a mobile with a fixed-bearing unicompartmental knee implant. Clin Orthop Relat Res. 2002 Nov;(404):62-70.
- Grodzki T, Haak H, Behrendt R, Merk H, Krauspe R. [Prospective randomized comparative study of early functional outcome of 2 knee joint endoprosthesis systems--rotation plateau versus fixed polyethylene inlay]. Z Orthop Ihre Grenzgeb. 2001 Sep-Oct;139(5):393-6. German. Erratum in: Z Orthop Ihre Grenzgeb 2002 Jul-Aug;140(4):460. Behrent R [corrected to Behrendt R].
- Kim YH, Kook HK, Kim JS. Comparison of fixed-bearing and mobile-bearing total knee arthroplasties. Clin Orthop Relat Res. 2001 Nov;(392):101-15.
- Price AJ, Rees JL, Beard D, Juszczak E, Carter S, White S, de Steiger R, Dodd CA, Gibbons M, McLardy-Smith P, Goodfellow JW, Murray DW. A mobile-bearing total knee prosthesis compared with a fixed-bearing prosthesis. A multicentre single-blind randomised controlled trial. J Bone Joint Surg Br. 2003 Jan;85(1):62-7.
- Vertullo CJ, Easley ME, Scott WN, Insall JN. Mobile bearings in primary knee arthroplasty. J Am Acad Orthop Surg. 2001 Nov-Dec;9(6):355-64. Review.
- AAG-G-H-0301