Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear
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ClinicalTrials.gov Identifier: NCT01052233 |
Recruitment Status :
Enrolling by invitation
First Posted : January 20, 2010
Last Update Posted : January 21, 2015
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Tracking Information | |||||||
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First Submitted Date ICMJE | January 19, 2010 | ||||||
First Posted Date ICMJE | January 20, 2010 | ||||||
Last Update Posted Date | January 21, 2015 | ||||||
Study Start Date ICMJE | January 2010 | ||||||
Estimated Primary Completion Date | January 2016 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Radiological assessment of OA of the knee (Kellgren-Lawrence -classification) [ Time Frame: 2 and 10 years postoperatively ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
ACR (The American College of Rheumatology) clinical criteria for Osteoarthritis of the knee [ Time Frame: 2 and 10 years postoperatively ] | ||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear | ||||||
Official Title ICMJE | Effect of Arthroscopic Partial Resection of Degenerative Meniscus Tear on Development of Knee Osteoarthritis: Which is the Chicken and the Egg? | ||||||
Brief Summary | It has been previously demonstrated that the risk for the development of knee osteoarthritis is increased after both meniscus tear and meniscectomy. However, it is still unclear whether this is due to the meniscus tear per se, the surgery, or whether the development of knee osteoarthritis is completely independent of the two. Accordingly, the aim of the study is to investigate the effect of arthroscopic partial meniscectomy on the development of knee osteoarthritis 2 to 10 years after the procedure. | ||||||
Detailed Description | It has been previously demonstrated that the risk for the development/progression of knee osteoarthritis is increased after both meniscus tear and meniscectomy. However, it is still unclear whether this is due to the meniscus tear per se (i.e., adverse mechanical effect on knee cartilage), the surgery (resection of the meniscus, and subsequent loss of cushion within the knee), or whether the development of knee osteoarthritis is completely independent of the two. Accordingly, the aim of the study is to investigate the effect of Arthroscopic partial meniscectomy on the development of knee osteoarthritis 2 to 10 years after the procedure. Patients included in the study will be randomized into one of two groups: arthroscopic partial meniscectomy and diagnostic arthroscopy (sham-surgery). The presence of knee osteoarthritis will be assessed preoperatively and 2, 5, and 10 years after the operation. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Intervention ICMJE |
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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 | Enrolling by invitation | ||||||
Estimated Enrollment ICMJE |
160 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | January 2024 | ||||||
Estimated Primary Completion Date | January 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Ages ICMJE | 35 Years to 65 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Finland | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01052233 | ||||||
Other Study ID Numbers ICMJE | 9037/403/2006 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Teppo Jarvinen, Tampere University | ||||||
Original Responsible Party | Teppo Jarvinen, MD, PhD, Tampere University Hospital, Tampere | ||||||
Current Study Sponsor ICMJE | Tampere University | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Tampere University | ||||||
Verification Date | January 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |