Text Size

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

This study is currently recruiting participants.
Verified January 2012 by University of Tampere
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: January 30, 2012
Last verified: January 2012
History of Changes

January 19, 2010
January 30, 2012
January 2010
January 2014   (final data collection date for primary outcome measure)
Radiological assessment of OA of the knee (Kellgren-Lawrence -classification) [ Time Frame: 2 and 10 years postoperatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01052233 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear
Effect of Arthroscopic Partial Resection of Degenerative Meniscus Tear on Development of Knee Osteoarthritis: Which is the Chicken and the Egg?

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Osteoarthritis of the Knee
  • Arthroscopy
  • Meniscal Tear
  • Procedure: Arthroscopic partial meniscectomy
    Arthroscopic partial meniscectomy of the degenerative tear of medial meniscus
  • Procedure: Arthroscopy (diagnostic)
    Diagnostic arthroscopy of the knee
  • Active Comparator: Arthroscopic partial meniscectomy
    Arthroscopic partial resection of degenerative tear of medial meniscus
    Intervention: Procedure: Arthroscopic partial meniscectomy
  • Sham Comparator: Arthroscopy (diagnostic)
    Diagnostic arthroscopy of the knee
    Intervention: Procedure: Arthroscopy (diagnostic)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
January 2024
January 2014   (final data collection date for primary outcome measure)

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.
Both
35 Years to 65 Years
No
Contact: Raine Sihvonen, MD +358407351674 raine.sihvonen@fimnet.fi
Contact: Pirjo Toivonen, Pt +358356572827 pirjo.h.toivonen@tampere.fi
Finland
 
NCT01052233
9037/403/2006
Yes
Teppo Jarvinen, University of Tampere
University of Tampere
  • Helsinki University Central Hospital
  • Turku University Hospital
  • Kuopio University Hospital
  • Central Finland Hospital District
Study Chair: Raine Sihvonen, MD Tampere City Hospital
Principal Investigator: Teppo Järvinen, MD, PhD University of Tampere
University of Tampere
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP