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

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ClinicalTrials.gov Identifier: NCT01052233
Recruitment Status : Enrolling by invitation
First Posted : January 20, 2010
Last Update Posted : January 21, 2015
Sponsor:
Collaborators:
Helsinki University Central Hospital
Turku University Hospital
Kuopio University Hospital
Central Finland Hospital District
Information provided by (Responsible Party):
Teppo Jarvinen, Tampere University

Tracking Information
First Submitted Date  ICMJE January 19, 2010
First Posted Date  ICMJE January 20, 2010
Last Update Posted Date January 21, 2015
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2010)
Radiological assessment of OA of the knee (Kellgren-Lawrence -classification) [ Time Frame: 2 and 10 years postoperatively ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2010)
ACR (The American College of Rheumatology) clinical criteria for Osteoarthritis of the knee [ Time Frame: 2 and 10 years postoperatively ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear
Official Title  ICMJE Effect of Arthroscopic Partial Resection of Degenerative Meniscus Tear on Development of Knee Osteoarthritis: Which is the Chicken and the Egg?
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Osteoarthritis of the Knee
  • Arthroscopy
  • Meniscal Tear
Intervention  ICMJE
  • Procedure: Arthroscopic partial meniscectomy
    Arthroscopic partial meniscectomy of the degenerative tear of medial meniscus
  • Procedure: Arthroscopy (diagnostic)
    Diagnostic arthroscopy of the knee
Study Arms  ICMJE
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 19, 2010)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01052233
Other Study ID Numbers  ICMJE 9037/403/2006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Teppo Jarvinen, Tampere University
Original Responsible Party Teppo Jarvinen, MD, PhD, Tampere University Hospital, Tampere
Current Study Sponsor  ICMJE Tampere University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Helsinki University Central Hospital
  • Turku University Hospital
  • Kuopio University Hospital
  • Central Finland Hospital District
Investigators  ICMJE
Study Chair: Raine Sihvonen, MD Tampere City Hospital
Principal Investigator: Teppo Järvinen, MD, PhD Tampere University
PRS Account Tampere University
Verification Date January 2015

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