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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Helsinki University Central Hospital
Turku University Hospital
Kuopio University Hospital
Central Finland Hospital District
Information provided by (Responsible Party):
Teppo Jarvinen, University of Tampere
ClinicalTrials.gov Identifier:
NCT01052233
First received: January 19, 2010
Last updated: June 17, 2013
Last verified: June 2013
  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?

Resource links provided by NLM:


Further study details as provided by University of Tampere:

Primary Outcome Measures:
  • Radiological assessment of OA of the knee (Kellgren-Lawrence -classification) [ Time Frame: 2 and 10 years postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052233

Locations
Finland
Helsinki Central Hospital
Helsinki, Finland
Central Finland Hospital District
Jyväskylä, Finland
Kuopio University Hospital
Kuopio, Finland
Tampere City Hospital
Tampere, Finland, 33101
Turku University Hospital
Turku, Finland
Sponsors and Collaborators
University of Tampere
Helsinki University Central Hospital
Turku University Hospital
Kuopio University Hospital
Central Finland Hospital District
Investigators
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: June 17, 2013
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 September 18, 2014