Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear

Phase 4

• Conditions: Osteoarthritis of the Knee; Meniscal Tear; Arthroscopy
• Interventions: Procedure: Arthroscopic partial meniscectomy; Procedure: Arthroscopy (diagnostic)

• Registration Number: NCT01052233
• Lead Sponsor: Tampere University

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-20
• Last Update Posted: 2015-01-21
• Primary Completion: 2016-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Age: 35 to 65 years of age.
2. A pain located on the medial joint line of the knee that has persistent at least for 3 months.
3. Pain that can be provoked by palpation or compression of the joint line or a positive McMurray sign.
4. Tear of the medial meniscus on MRI.
5. Degenerative rupture of the medial meniscus confirmed at arthroscopy.

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Exclusion Criteria

1. Acute, trauma-induced onset of symptoms.
2. Locking or painful snapping of the knee joint.
3. A surgical operation performed on the affected knee.
4. Osteoarthritis of the medial compartment of the knee (determined by clinical criteria of the ACR).
5. Osteoarthritis on knee radiographs (Kellgren-Lawrence > 1).
6. Acute (within the previous year) fractures of the knee.
7. Decreased range of motion of the knee.
8. Instability of the knee.
9. MRI assessment showing a tumor or any other complaint requiring surgical or other means of treatment.
10. Arthroscopic assessment showing anything other than a degenerative tear of the medial meniscus requiring surgical intervention.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthroscopic partial meniscectomy	Arthroscopic partial meniscectomy	Arthroscopic partial resection of degenerative tear of medial meniscus
Arthroscopy (diagnostic)	Arthroscopy (diagnostic)	Diagnostic arthroscopy of the knee

Primary Outcome Measures

Name	Time	Method
Radiological assessment of OA of the knee (Kellgren-Lawrence -classification)	2 and 10 years postoperatively

Secondary Outcome Measures

Name	Time	Method
ACR (The American College of Rheumatology) clinical criteria for Osteoarthritis of the knee	2 and 10 years postoperatively

Trial Locations

Locations (5)

Turku University Hospital; 🇫🇮 Turku, Finland

Helsinki Central Hospital; 🇫🇮 Helsinki, Finland

Central Finland Hospital District; 🇫🇮 Jyväskylä, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Tampere City Hospital; 🇫🇮 Tampere, Finland