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History of Changes for Study: NCT00549172
Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear
Latest version (submitted May 24, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 24, 2007 None (earliest Version on record)
2 October 26, 2007 Recruitment Status, Contacts/Locations and Study Status
3 October 30, 2007 Study Status
4 May 22, 2008 Study Status and Contacts/Locations
5 February 17, 2009 Study Status and Sponsor/Collaborators
6 January 19, 2010 Study Status, Contacts/Locations and Sponsor/Collaborators
7 January 30, 2012 Recruitment Status, Sponsor/Collaborators, Study Status and Contacts/Locations
8 June 17, 2013 Recruitment Status, Study Status, Study Design and Conditions
9 August 1, 2013 Outcome Measures and Study Status
10 March 16, 2015 Study Status, Outcome Measures and Results
11 May 24, 2018 Study Status, Outcome Measures
Comparison Format:

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Study NCT00549172
Submitted Date:  October 24, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: R06157
Brief Title: Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear
Official Title: Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2007
Overall Status: Not yet recruiting
Study Start: November 2007
Primary Completion:
Study Completion: December 2009 [Anticipated]
First Submitted: October 24, 2007
First Submitted that
Met QC Criteria:
October 24, 2007
First Posted: October 25, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 24, 2007
Last Update Posted: October 25, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Tampere University
Responsible Party:
Collaborators:
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: Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat meniscal tears. Improvements have been reported both after arthroscopy and with conservative treatment, however no direct comparison exist. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial.
Detailed Description: Middle-aged men and women with degenerative meniscal tears constitute a large group of patients presenting with knee pain, sometimes accompanied with swelling and loss of function. Many meniscal tears occur without a trauma in physically active individuals as well as in older people and could be a part of early osteoarthritis. Partial arthroscopic meniscectomy is the most common orthopaedic procedure and is used to treat patients with meniscal tears. Many patients report improvement after arthroscopy referring especially to reduced knee pain, better knee function and improved quality of life. However, similar results have also been obtained with conservative treatment (physical therapy) of patients with degenerative meniscal tears. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial. The outcome of arthroscopic partial meniscectomy (vs. sham surgery) is assessed using the Lysholm knee score and pain at rest and activity (VAS) at 2, 6 and 12 months after the operation. In addition, the functional outcome is assessed using the WOMET knee score (a disease-specific quality of life -knee score development on the assessment of meniscal pathology), the general quality of life score (15-D), and cost-effectiveness analysis.
Open or close this module Conditions
Conditions: Degenerative Tear of the Medial Meniscus of Knee
Keywords: Knee
Meniscus
Degenerative
Operative
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 140 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Operative (O)
Partial resection of degenerative tear of medial meniscus
Procedure: Operative (partial arthroscopy)
Partial arthroscopic resection of degenerative rupture of the medial meniscus
Sham Comparator: Conservative (K)
Arthroscopy (diagnostic)
Procedure: Conservative (diagnostic arthroscopy)
Diagnostic arthroscopy
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The Lysholm knee score
[ Time Frame: One year ]

2. pain at rest and activity (VAS)
[ Time Frame: One year ]

Secondary Outcome Measures:
1. WOMET (Western Ontario Meniscal Tear -disease specific quality of life -assessment tool)
[ Time Frame: One year ]

2. 15-D (general quality of life -assessment tool)
[ Time Frame: One year ]

Open or close this module Eligibility
Minimum Age: 35 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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: +358-02077-72126
Email: raine.sihvonen@fimnet.fi
Central Contact Backup: Pirjo Toivonen, Phys. Ther.
Telephone: +358-02077-72827
Email: Pirjo.H.Toivonen@tampere.fi
Study Officials: Teppo LN Jarvinen, MD, PhD
Study Chair
Tampere University
Raine Sihvonen, MD
Principal Investigator
Tampere City Hospital
Mika Paavola, MD, PhD
Study Director
University of Helsinki
Antti Malmivaara, MD, PhD
Study Director
University of Helsinki
Locations: Finland
Hatanpää City Hospital
Tampere, Finland, FI-33101
Contact:Principal Investigator: Raine Sihvonen, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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