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History of Changes for Study: NCT01052233
Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear
Latest version (submitted January 20, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 19, 2010 None (earliest Version on record)
2 January 30, 2012 Sponsor/Collaborators and Study Status
3 June 17, 2013 Recruitment Status, Study Status and Contacts/Locations
4 January 20, 2015 Study Status
Comparison Format:

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Study NCT01052233
Submitted Date:  January 19, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: 9037/403/2006
Brief Title: Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear
Official Title: Effect of Arthroscopic Partial Resection of Degenerative Meniscus Tear on Development of Knee Osteoarthritis: Which is the Chicken and the Egg?
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2010
Overall Status: Recruiting
Study Start: January 2010
Primary Completion: January 2014 [Anticipated]
Study Completion: January 2022 [Anticipated]
First Submitted: January 19, 2010
First Submitted that
Met QC Criteria:
January 19, 2010
First Posted: January 20, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 19, 2010
Last Update Posted: January 20, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Tampere University
Responsible Party:
Collaborators: Helsinki University Central Hospital
Turku University Hospital
Kuopio University Hospital
Central Finland Hospital District
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Osteoarthritis of the Knee
Arthroscopy
Meniscal Tear
Keywords: Sham-surgery
Development of osteoarthritis
Randomized, double-blinded, placebo-controlled
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 160 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Radiological assessment of OA of the knee (Kellgren-Lawrence -classification)
[ Time Frame: 2 and 10 years postoperatively ]

Secondary Outcome Measures:
1. ACR (The American College of Rheumatology) clinical criteria for Osteoarthritis of the knee
[ Time Frame: 2 and 10 years postoperatively ]

Open or close this module Eligibility
Minimum Age: 35 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Raine Sihvonen, MD
Telephone: +358407351674
Email: raine.sihvonen@fimnet.fi
Central Contact Backup: Pirjo Toivonen, Pt
Telephone: +358356572827
Email: pirjo.h.toivonen@tampere.fi
Study Officials: Raine Sihvonen, MD
Study Chair
Tampere City Hospital
Teppo Järvinen, MD, PhD
Principal Investigator
Tampere University
Locations: Finland
Helsinki Central Hospital
[Recruiting]
Helsinki, Finland
Contact:Principal Investigator: Juha Kalske, MD
Central Finland Hospital District
[Recruiting]
Jyväskylä, Finland
Contact:Principal Investigator: Heikki Nurmi, MD
Kuopio University Hospital
[Recruiting]
Kuopio, Finland
Contact:Principal Investigator: Antti Joukainen, MD, PhD
Tampere City Hospital
[Recruiting]
Tampere, Finland, 33101
Contact:Principal Investigator: Raine Sihvonen, MD
Turku University Hospital
[Recruiting]
Turku, Finland
Contact:Principal Investigator: Ari Itälä, MD, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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