Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR
This study is ongoing, but not recruiting participants.
Sponsor:
Martina Hansen's Hospital
Information provided by:
Martina Hansen's Hospital
ClinicalTrials.gov Identifier:
NCT01030848
First received: December 11, 2009
Last updated: December 14, 2009
Last verified: December 2009
| Tracking Information | |||||
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| First Received Date ICMJE | December 11, 2009 | ||||
| Last Updated Date | December 14, 2009 | ||||
| Start Date ICMJE | February 2003 | ||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Knee injury and Osteoarthritis Outcome Score [ Time Frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01030848 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 | Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR | ||||
| Official Title ICMJE | Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR - A Prospective Longitudinal Study With Repetitive Measures of KOOS | ||||
| Brief Summary | The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first four years following TKR using the LCS rotating platform prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Consecutive patients operated with total knee arthroplasty at Martina Hansens Hospital |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Total Knee Replacement (LCS rotating platform)
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| Study Group/Cohort (s) | Patients with knee osteoarthritis
Intervention: Device: Total Knee Replacement (LCS rotating platform) |
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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 | Active, not recruiting | ||||
| Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | September 2013 | ||||
| Primary Completion Date | September 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 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01030848 | ||||
| Other Study ID Numbers ICMJE | TKN-001, 19039 (NSD) | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Tor Kjetil Nerhus/ Consultant orthopaedic surgeon, Martina Hansens Hospital | ||||
| Study Sponsor ICMJE | Martina Hansen's Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Martina Hansen's Hospital | ||||
| Verification Date | December 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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