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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 14, 2008 | ||||
| Last Updated Date | June 4, 2009 | ||||
| Start Date ICMJE | May 2009 | ||||
| Estimated Primary Completion Date | October 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Three way randomized comparison of migration (prosthetic fixation) by Model Based RSA with three different Oxford Uni Knee prosthesis (both tibial trays and femoral components will be as-sessed) [ Time Frame: 2016 ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Three way randomized comparison of migration (prosthetic fixation) by Model Based RSA with three different Oxford Uni Knee prosthesis (both tibial trays and femoral components will be as-sessed) [ Time Frame: 2014 ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00679120 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Fluoroscopy (screening) roentgenograms for determination of RLL around the tibial component and "overhang" of the tibial trays. [ Time Frame: 2016 ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
Fluoroscopy (screening) roentgenograms for determination of RLL around the tibial component and "overhang" of the tibial trays. [ Time Frame: 2014 ] [ Designated as safety issue: Yes ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Oxford Partial Knee Replacement. A Randomized Clinical Trial of Three Implant Types | ||||
| Official Title ICMJE | Oxford Partial Knee Replacement: A Randomized Clinical Trial of Three Implant Types. | ||||
| Brief Summary | The purpose of this scientific study is to clarify whether there is a relationship between the appearance of radiolucent lines in bone-cement interphase of the tibial component of the different models of the Oxford Uni Knee prosthesis and poor prognosis of these prostheses. This will be accomplished in a se-ries of three different Oxford Uni Knees. |
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| Detailed Description | The purpose of this scientific study is to clarify whether there is a relationship between the appearance of radiolucent lines in bone-cement interphase of the tibial component of the different models of the Oxford Uni Knee prosthesis and poor prognosis of these prostheses. This will be accomplished in a se-ries of three different Oxford Uni Knees by studying:
The study would be considered a success if all designs of the prostheses are firmly fixed and remain so during the entire period of study, that is, no increasing migration is seen using RSA. It would be a suc-cess if the appearance of RLL beneath the implant in the proximal tibia is unrelated to bone loss and prosthesis migration. The hypotheses are:
The primary parameters of effect are RLL, RSA and DEXA. The secondary parameters of effect are bone-remodelling, wear analysis, Oxford Knee Score (ADL) and ROM. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Osteoarthritis, Knee | ||||
| Intervention ICMJE | Device: Oxford Uni Knee | ||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 75 | ||||
| Estimated Completion Date | October 2016 | ||||
| Estimated Primary Completion Date | October 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00679120 | ||||
| Responsible Party | Professor Kjeld Soballe, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C | ||||
| Study ID Numbers ICMJE | 20070258 | ||||
| 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 | June 2009 | ||||
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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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