Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?
The purpose of this study is to determine whether a knee arthroscopy is effective in the treatment of middleaged patients with meniscal symptoms also receiving a standardised exercise program.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?|
- KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale [ Time Frame: 12 month ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Tegner activity scale [ Time Frame: 12 month ] [ Designated as safety issue: No ]
- KOOS (Symptoms, ADL, Sport/rec, QOL subscores) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
- Functional tests [ Time Frame: 3 month ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2010|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Arthroscopy
Knee arthroscopy + Exercise therapy
Procedure: Knee arthroscopy
Knee arthroscopy within 4 weeks.
Other Name: Knee arthroscopy
No Intervention: Exercise therapy
Exercise therapy alone
There are no studies proving a significant positive effect of a knee arthroscopy in middleaged patients with meniscal symptoms in excess of a structured rehabilitation program. In this study consecutive patients aged 45-64 years referred to the orthopaedic department at the University hospital Linköping for a suspected meniscal injury will be randomised to a rehabilitation program or a knee arthroscopy + the same rehabilitation program. Functional tests will be performed by a physiotherapist. There will be patient administrated questionaries sent out after 3 and 12 month.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288768
|Orthopaedic dept. University Hospital Linköping|
|Linköping, Sweden, 581 85|
|Principal Investigator:||Håkan Gauffin, MD PhD||Orthopaedic dept. University Hospital, Linköping, Sweden.|