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

Osteoarthritis of the Knee Clinical Trial

Official title:

Effect of Arthroscopic Partial Resection of Degenerative Meniscus Tear on Development of Knee Osteoarthritis: Which is the Chicken and the Egg?

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01052233
• Other study ID #: 9037/403/2006
• 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

Related Conditions & MeSH terms

• Arthroscopy
• Meniscal Tear
• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

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