Comparison of Rotating vs. Fixed Platform of the COLUMBUS Knee Prosthesis
NCT ID: NCT00822640
Last Updated: 2013-05-14
Study Results
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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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2004-03-31
2008-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Columbus Knee Prosthesis with rotating Platform
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.
2
Columbus Knee Prosthesis with fixed platform
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* agreement to participate in this study
* Patient age between 40 and 90 years
Exclusion Criteria
* 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
40 Years
90 Years
ALL
No
Sponsors
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Aesculap AG
INDUSTRY
Responsible Party
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Schön Kliniken, Klinikum Eilbek
Principal Investigators
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Frank Lampe, MD
Role: PRINCIPAL_INVESTIGATOR
Schön Kliniken Klinikum Eilbek
Locations
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Frank Lampe, MD
Hamburg, , Germany
Countries
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References
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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. doi: 10.1097/00003086-200107000-00008.
Buechel FF Sr. Long-term followup after mobile-bearing total knee replacement. Clin Orthop Relat Res. 2002 Nov;(404):40-50. doi: 10.1097/00003086-200211000-00008.
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. doi: 10.1097/00003086-200111000-00027.
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.
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). 2003 Jun;18(5):410-8. doi: 10.1016/s0268-0033(03)00044-5.
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. doi: 10.1177/230949900100900109.
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. doi: 10.1097/00003086-200211000-00011.
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. doi: 10.1055/s-2001-17980. German.
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. doi: 10.1097/00003086-200111000-00013.
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. doi: 10.1302/0301-620x.85b1.13233.
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. doi: 10.5435/00124635-200111000-00001.
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.
Other Identifiers
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AAG-G-H-0301
Identifier Type: -
Identifier Source: org_study_id
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