Rehabilitation After Total Knee Arthroplasty (TKA) - PFC Rotating Versus Fixed Bearing
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Aarhus.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Aarhus
Collaborators:
Regionshospitalet Silkeborg
Gigtforeningen
Protesekompagniet
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01150929
First received: June 14, 2010
Last updated: February 18, 2011
Last verified: February 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 14, 2010 | ||||||||
| Last Updated Date | February 18, 2011 | ||||||||
| Start Date ICMJE | March 2007 | ||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Radio Stereometric Analysis [ Time Frame: 24 months ] [ Designated as safety issue: No ] Patients are analysed with stereo x-rays to asses implant micromigration. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01150929 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Rehabilitation After Total Knee Arthroplasty (TKA) - PFC Rotating Versus Fixed Bearing | ||||||||
| Official Title ICMJE | Rehabilitation After Total Knee Arthroplasty - Rotating Platform Versus Fixed Bearing Polyethylene | ||||||||
| Brief Summary | The purpose of this study is to determine whether patient rehabilitation is equal for patients operated with two different knee implant designs. The patients are randomized to treatment with either a simple hinge design implant (fixed bearing) or an implant with a mobile bearing polyethylene. This design difference might in principle enable the patients in the latter group to rehabilitate towards a more normal gait pattern. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
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| Condition ICMJE | Osteoarthritis | ||||||||
| Intervention ICMJE | Device: P.F.C. Sigma knee arthroplasty
Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene
Other Name: PFC Sigma from DePuy International implants used. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | July 2012 | ||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 50 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01150929 | ||||||||
| Other Study ID Numbers ICMJE | 20050031 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Michael Tjornild/MD, PhD-student, Regionshospitalet Silkeborg | ||||||||
| Study Sponsor ICMJE | University of Aarhus | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||||||
| Verification Date | February 2011 | ||||||||
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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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