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Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear

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ClinicalTrials.gov Identifier: NCT00549172
Recruitment Status : Completed
First Posted : October 25, 2007
Results First Posted : March 23, 2015
Last Update Posted : June 29, 2018
Sponsor:
Collaborators:
Helsinki University Central Hospital
Kuopio University Hospital
Turku University Hospital
Central Finland Hospital District
Information provided by (Responsible Party):
Raine Sihvonen, Tampere University

Tracking Information
First Submitted Date  ICMJE October 24, 2007
First Posted Date  ICMJE October 25, 2007
Results First Submitted Date  ICMJE March 16, 2015
Results First Posted Date  ICMJE March 23, 2015
Last Update Posted Date June 29, 2018
Study Start Date  ICMJE October 2007
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2015)
  • The Lysholm Knee Score [ Time Frame: One year ]
    The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms.
  • Pain After Exercise (VAS) [ Time Frame: One year ]
    Knee pain after exercise (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.
  • WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool) [ Time Frame: One year ]
    The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items addressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possible score, and 0 is the worst possible score.
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2007)
  • The Lysholm knee score [ Time Frame: One year ]
  • pain at rest and activity (VAS) [ Time Frame: One year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
  • 15-D (General Quality of Life -Assessment Tool) [ Time Frame: One year ]
    The 15D instrument is a generic health-related quality-of-life instrument comprising 15 dimensions. The maximum 15D score is 1 (full health), and the minimum score is 0 (death).
  • Pain at Rest (VAS) [ Time Frame: One year ]
    Knee pain at rest (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.
  • Cost Effectiveness [ Time Frame: 1 and 2 years ]
    Cost effectiveness data comparing arthroscopic partial meniscectomy and diagnostic arthroscopy. Costs are based on healthcare utilisation and sickness absence.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2007)
  • WOMET (Western Ontario Meniscal Tear -disease specific quality of life -assessment tool) [ Time Frame: One year ]
  • 15-D (general quality of life -assessment tool) [ Time Frame: One year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear
Official Title  ICMJE Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Procedure: Operative (partial arthroscopy)
    Partial arthroscopic resection of degenerative rupture of the medial meniscus
  • Procedure: Conservative (diagnostic arthroscopy)
    Diagnostic arthroscopy
Study Arms  ICMJE
  • Active Comparator: Operative (O)
    Partial resection of degenerative tear of medial meniscus
    Intervention: Procedure: Operative (partial arthroscopy)
  • Sham Comparator: Conservative (K)
    Arthroscopy (diagnostic)
    Intervention: Procedure: Conservative (diagnostic arthroscopy)
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2013)
146
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2007)
140
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (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 Yes
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 NCT00549172
Other Study ID Numbers  ICMJE R06157
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Raine Sihvonen, Tampere University
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Tampere University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Helsinki University Central Hospital
  • Kuopio University Hospital
  • Turku University Hospital
  • Central Finland Hospital District
Investigators  ICMJE
Study Chair: Teppo LN Jarvinen, MD, PhD Tampere University
Principal Investigator: Raine TA Sihvonen, MD Tampere City Hospital
Study Director: Mika Paavola, MD, PhD University of Helsinki
Study Director: Antti Malmivaara, MD, PhD University of Helsinki
PRS Account Tampere University
Verification Date May 2018

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