Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear
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| ClinicalTrials.gov Identifier: NCT01052233 |
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Recruitment Status :
Enrolling by invitation
First Posted : January 20, 2010
Last Update Posted : January 21, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis of the Knee Arthroscopy Meniscal Tear | Procedure: Arthroscopic partial meniscectomy Procedure: Arthroscopy (diagnostic) | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 160 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Effect of Arthroscopic Partial Resection of Degenerative Meniscus Tear on Development of Knee Osteoarthritis: Which is the Chicken and the Egg? |
| Study Start Date : | January 2010 |
| Estimated Primary Completion Date : | January 2016 |
| Estimated Study Completion Date : | January 2024 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arthroscopic partial meniscectomy
Arthroscopic partial resection of degenerative tear of medial meniscus
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Procedure: Arthroscopic partial meniscectomy
Arthroscopic partial meniscectomy of the degenerative tear of medial meniscus |
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Sham Comparator: Arthroscopy (diagnostic)
Diagnostic arthroscopy of the knee
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Procedure: Arthroscopy (diagnostic)
Diagnostic arthroscopy of the knee |
- Radiological assessment of OA of the knee (Kellgren-Lawrence -classification) [ Time Frame: 2 and 10 years postoperatively ]
- ACR (The American College of Rheumatology) clinical criteria for Osteoarthritis of the knee [ Time Frame: 2 and 10 years postoperatively ]
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| Ages Eligible for Study: | 35 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: 35 to 65 years of age.
- A pain located on the medial joint line of the knee that has persistent at least for 3 months.
- Pain that can be provoked by palpation or compression of the joint line or a positive McMurray sign.
- Tear of the medial meniscus on MRI.
- Degenerative rupture of the medial meniscus confirmed at arthroscopy.
Exclusion Criteria:
- Acute, trauma-induced onset of symptoms.
- Locking or painful snapping of the knee joint.
- A surgical operation performed on the affected knee.
- Osteoarthritis of the medial compartment of the knee (determined by clinical criteria of the ACR).
- Osteoarthritis on knee radiographs (Kellgren-Lawrence > 1).
- Acute (within the previous year) fractures of the knee.
- Decreased range of motion of the knee.
- Instability of the knee.
- MRI assessment showing a tumor or any other complaint requiring surgical or other means of treatment.
- Arthroscopic assessment showing anything other than a degenerative tear of the medial meniscus requiring surgical intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052233
| Finland | |
| Helsinki Central Hospital | |
| Helsinki, Finland | |
| Central Finland Hospital District | |
| Jyväskylä, Finland | |
| Kuopio University Hospital | |
| Kuopio, Finland | |
| Tampere City Hospital | |
| Tampere, Finland, 33101 | |
| Turku University Hospital | |
| Turku, Finland | |
| Study Chair: | Raine Sihvonen, MD | Tampere City Hospital | |
| Principal Investigator: | Teppo Järvinen, MD, PhD | Tampere University |
| Responsible Party: | Teppo Jarvinen, Principal Investigator, Tampere University |
| ClinicalTrials.gov Identifier: | NCT01052233 |
| Other Study ID Numbers: |
9037/403/2006 |
| First Posted: | January 20, 2010 Key Record Dates |
| Last Update Posted: | January 21, 2015 |
| Last Verified: | January 2015 |
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Sham-surgery Development of osteoarthritis Randomized, double-blinded, placebo-controlled |
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Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |