Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis of the Knee Arthroscopy Meniscal Tear |
Procedure: Arthroscopic partial meniscectomy Procedure: Arthroscopy (diagnostic) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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? |
- Radiological assessment of OA of the knee (Kellgren-Lawrence -classification) [ Time Frame: 2 and 10 years postoperatively ] [ Designated as safety issue: No ]
- ACR (The American College of Rheumatology) clinical criteria for Osteoarthritis of the knee [ Time Frame: 2 and 10 years postoperatively ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2024 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arthroscopic partial meniscectomy
Arthroscopic partial resection of degenerative tear of medial meniscus
|
Procedure: Arthroscopic partial meniscectomy
Arthroscopic partial meniscectomy of the degenerative tear of medial meniscus
|
|
Sham Comparator: Arthroscopy (diagnostic)
Diagnostic arthroscopy of the knee
|
Procedure: Arthroscopy (diagnostic)
Diagnostic arthroscopy of the knee
|
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.
Eligibility| Ages Eligible for Study: | 35 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| Contact: Raine Sihvonen, MD | +358407351674 | raine.sihvonen@fimnet.fi |
| Contact: Pirjo Toivonen, Pt | +358356572827 | pirjo.h.toivonen@tampere.fi |
| Finland | |
| Helsinki Central Hospital | Recruiting |
| Helsinki, Finland | |
| Principal Investigator: Juha Kalske, MD | |
| Central Finland Hospital District | Recruiting |
| Jyväskylä, Finland | |
| Principal Investigator: Heikki Nurmi, MD | |
| Kuopio University Hospital | Recruiting |
| Kuopio, Finland | |
| Principal Investigator: Antti Joukainen, MD, PhD | |
| Tampere City Hospital | Recruiting |
| Tampere, Finland, 33101 | |
| Principal Investigator: Raine Sihvonen, MD | |
| Turku University Hospital | Recruiting |
| Turku, Finland | |
| Principal Investigator: Ari Itälä, MD, PhD | |
| Study Chair: | Raine Sihvonen, MD | Tampere City Hospital |
| Principal Investigator: | Teppo Järvinen, MD, PhD | University of Tampere |
More Information
No publications provided
| Responsible Party: | Teppo Jarvinen, Principal Investigator, University of Tampere |
| ClinicalTrials.gov Identifier: | NCT01052233 History of Changes |
| Other Study ID Numbers: | 9037/403/2006 |
| Study First Received: | January 19, 2010 |
| Last Updated: | January 30, 2012 |
| Health Authority: | Finland: Medical Study Approval Board of Tampere City |
Keywords provided by University of Tampere:
|
Sham-surgery Development of osteoarthritis Randomized, double-blinded, placebo-controlled |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013