Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear
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Purpose
Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat meniscal tears. Improvements have been reported both after arthroscopy and with conservative treatment, however no direct comparison exist. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis, Knee |
Procedure: Operative (partial arthroscopy) Procedure: Conservative (diagnostic arthroscopy) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee |
- The Lysholm knee score [ Time Frame: One year ] [ Designated as safety issue: No ]
- pain at rest and activity (VAS) [ Time Frame: One year ] [ Designated as safety issue: No ]
- WOMET (Western Ontario Meniscal Tear -disease specific quality of life -assessment tool) [ Time Frame: One year ] [ Designated as safety issue: No ]
- 15-D (general quality of life -assessment tool) [ Time Frame: One year ] [ Designated as safety issue: No ]
| Enrollment: | 146 |
| Study Start Date: | October 2007 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Operative (O)
Partial resection of degenerative tear of medial meniscus
|
Procedure: Operative (partial arthroscopy)
Partial arthroscopic resection of degenerative rupture of the medial meniscus
|
|
Sham Comparator: Conservative (K)
Arthroscopy (diagnostic)
|
Procedure: Conservative (diagnostic arthroscopy)
Diagnostic arthroscopy
|
Detailed Description:
Middle-aged men and women with degenerative meniscal tears constitute a large group of patients presenting with knee pain, sometimes accompanied with swelling and loss of function. Many meniscal tears occur without a trauma in physically active individuals as well as in older people and could be a part of early osteoarthritis. Partial arthroscopic meniscectomy is the most common orthopaedic procedure and is used to treat patients with meniscal tears. Many patients report improvement after arthroscopy referring especially to reduced knee pain, better knee function and improved quality of life. However, similar results have also been obtained with conservative treatment (physical therapy) of patients with degenerative meniscal tears. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial. The outcome of arthroscopic partial meniscectomy (vs. sham surgery) is assessed using the Lysholm knee score and pain at rest and activity (VAS) at 2, 6 and 12 months after the operation. In addition, the functional outcome is assessed using the WOMET knee score (a disease-specific quality of life -knee score development on the assessment of meniscal pathology), the general quality of life score (15-D), and cost-effectiveness analysis.
Eligibility| Ages Eligible for Study: | 35 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Finland | |
| Helsinki Central Hospital | |
| Helsinki, Finland | |
| Central Finland Hospital District | |
| Jyväskylä, Finland | |
| Kuopio University Hospital | |
| Kuopio, Finland | |
| Hatanpää City Hospital | |
| Tampere, Finland, FI-33101 | |
| Turku University Hospital | |
| Turku, Finland | |
| Study Chair: | Teppo LN Jarvinen, MD, PhD | University of Tampere |
| Principal Investigator: | Raine TA Sihvonen, MD | Tampere City Hospital |
| Study Director: | Mika Paavola, MD, PhD | Helsinki University |
| Study Director: | Antti Malmivaara, MD, PhD | Helsinki University |
More Information
No publications provided
| Responsible Party: | Raine Sihvonen, Principal Investigator, University of Tampere |
| ClinicalTrials.gov Identifier: | NCT00549172 History of Changes |
| Other Study ID Numbers: | R06157 |
| Study First Received: | October 24, 2007 |
| Last Updated: | June 17, 2013 |
| Health Authority: | Finland: Ministry of Social Affairs and Health |
Keywords provided by University of Tampere:
|
Osteoarthritis, Knee Arthroscopic Surgery Menisci, Medial Placebo Effect Treatment Efficacy |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013