Comparison of Rotating vs. Fixed Platform of the COLUMBUS Knee Prosthesis
| Tracking Information | |||||
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| First Received Date ICMJE | January 13, 2009 | ||||
| Last Updated Date | May 13, 2013 | ||||
| Start Date ICMJE | March 2004 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Knee Society Score [ Time Frame: 12 Months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00822640 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Rotating vs. Fixed Platform of the COLUMBUS Knee Prosthesis | ||||
| Official Title ICMJE | Clinical Outcome With Attention to Functional Results One Year After Fixed or Mobile Bearing Total Knee Replacement in a Randomized Controlled Trial | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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 Name: Columbus Knee Prosthesis |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00822640 | ||||
| Other Study ID Numbers ICMJE | AAG-G-H-0301 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. med. Frank Lampe, Schön Kliniken, Klinikum Eilbek | ||||
| Study Sponsor ICMJE | Aesculap AG | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Aesculap AG | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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