Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?
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|ClinicalTrials.gov Identifier: NCT01288768|
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : May 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Meniscus Injury||Procedure: Knee arthroscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Active Comparator: Arthroscopy
Knee arthroscopy + Exercise therapy
Procedure: Knee arthroscopy
Knee arthroscopy within 4 weeks.
No Intervention: Exercise therapy
Exercise therapy alone
- KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale [ Time Frame: 12 month ]KOOS is a 42 item selfadministrated questionnaire with 5 separate subscales; pain, symptoms, activities of daily living (ADL), sport and recreation, quality of life (QoL). A change of approximately 10 is considered a clinical important difference (CID). At 12 month after the randomization the "arthroscopy+exercise therapy" arm will be compared to the "exercise therapy alone" arm.
- KOOS (Knee injury and Osteoarthritis Outcome Score) [ Time Frame: 3 month ]
- Tegner activity scale [ Time Frame: 12 month ]
- KOOS (Symptoms, ADL, Sport/rec, QOL subscores) [ Time Frame: 12 month ]
- Functional tests [ Time Frame: 3 month ]Squatting (possible without pain, possible with pain, not possible). SOLEC ( one-legged stance) barefoot. Best time for three trials. Standing up from a chair on one leg, maximum repetitions in 30 sec. All test supervised by a physiotherapist.
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): NCT01288768
|Orthopaedic dept. University Hospital Linköping|
|Linköping, Sweden, 581 85|
|Principal Investigator:||Håkan Gauffin, MD PhD||Orthopaedic dept. University Hospital, Linköping, Sweden.|