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Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00549172
Recruitment Status : Completed
First Posted : October 25, 2007
Results First Posted : March 23, 2015
Last Update Posted : January 13, 2023
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Procedure: Operative (partial arthroscopy) Procedure: Conservative (diagnostic arthroscopy) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee
Study Start Date : October 2007
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00549172


Locations
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Finland
Helsinki Central Hospital
Helsinki, Finland
Central Finland Hospital District
Jyväskylä, Finland
Kuopio University Hospital
Kuopio, Finland
Hatanpää City Hospital
Tampere, Finland, FI-33101
Turku University Hospital
Turku, Finland
Sponsors and Collaborators
Tampere University
Helsinki University Central Hospital
Kuopio University Hospital
Turku University Hospital
Central Finland Hospital District
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Raine Sihvonen, Principal Investigator, Tampere University
ClinicalTrials.gov Identifier: NCT00549172    
Other Study ID Numbers: R06157
First Posted: October 25, 2007    Key Record Dates
Results First Posted: March 23, 2015
Last Update Posted: January 13, 2023
Last Verified: December 2022
Keywords provided by Raine Sihvonen, Tampere University:
Osteoarthritis, Knee
Arthroscopic Surgery
Menisci, Medial
Placebo Effect
Treatment Efficacy
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases