Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear
|ClinicalTrials.gov Identifier: NCT00549172|
Recruitment Status : Completed
First Posted : October 25, 2007
Results First Posted : March 23, 2015
Last Update Posted : March 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Procedure: Operative (partial arthroscopy) Procedure: Conservative (diagnostic arthroscopy)||Phase 2 Phase 3|
|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.
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||University of Tampere|
|Principal Investigator:||Raine TA Sihvonen, MD||Tampere City Hospital|
|Study Director:||Mika Paavola, MD, PhD||Helsinki University|
|Study Director:||Antti Malmivaara, MD, PhD||Helsinki University|