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 : January 13, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Procedure: Operative (partial arthroscopy) Procedure: Conservative (diagnostic arthroscopy)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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)
Procedure: Conservative (diagnostic arthroscopy)
- 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.
- 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.
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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|
- Age: 35 to 65 years of age.
- A pain located on the medial joint line of the knee that has persistent at least for 3 months.
- Pain that can be provoked by palpation or compression of the joint line or a positive McMurray sign.
- Tear of the medial meniscus on MRI.
- Degenerative rupture of the medial meniscus confirmed at arthroscopy.
- Acute, trauma-induced onset of symptoms.
- Locking or painful snapping of the knee joint.
- A surgical operation performed on the affected knee.
- Osteoarthritis of the medial compartment of the knee (determined by clinical criteria of the ACR).
- Osteoarthritis on knee radiographs (Kellgren-Lawrence > 1).
- Acute (within the previous year) fractures of the knee.
- Decreased range of motion of the knee.
- Instability of the knee.
- MRI assessment showing a tumor or any other complaint requiring surgical or other means of treatment.
- Arthroscopic assessment showing anything other than a degenerative tear of the medial meniscus requiring surgical intervention.
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
|Helsinki Central Hospital|
|Central Finland Hospital District|
|Kuopio University Hospital|
|Hatanpää City Hospital|
|Tampere, Finland, FI-33101|
|Turku University Hospital|
|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|
|Responsible Party:||Raine Sihvonen, Principal Investigator, Tampere University|
|Other Study ID Numbers:||
|First Posted:||October 25, 2007 Key Record Dates|
|Results First Posted:||March 23, 2015|
|Last Update Posted:||January 13, 2023|
|Last Verified:||December 2022|