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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01052233
Other study ID # 9037/403/2006
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received January 19, 2010
Last updated January 20, 2015
Start date January 2010
Est. completion date January 2024

Study information

Verified date January 2015
Source University of Tampere
Contact n/a
Is FDA regulated No
Health authority Finland: Medical Study Approval Board of Tampere City
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 160
Est. completion date January 2024
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 65 Years
Eligibility 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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Procedure:
Arthroscopic partial meniscectomy
Arthroscopic partial meniscectomy of the degenerative tear of medial meniscus
Arthroscopy (diagnostic)
Diagnostic arthroscopy of the knee

Locations

Country Name City State
Finland Helsinki Central Hospital Helsinki
Finland Central Finland Hospital District Jyväskylä
Finland Kuopio University Hospital Kuopio
Finland Tampere City Hospital Tampere
Finland Turku University Hospital Turku

Sponsors (5)

Lead Sponsor Collaborator
University of Tampere Central Finland Hospital District, Helsinki University Central Hospital, Kuopio University Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiological assessment of OA of the knee (Kellgren-Lawrence -classification) 2 and 10 years postoperatively No
Secondary ACR (The American College of Rheumatology) clinical criteria for Osteoarthritis of the knee 2 and 10 years postoperatively No
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