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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
Sponsor:
Information provided by (Responsible Party):
Hakan Gauffin, University Hospital, Linkoeping

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Meniscus Injury Procedure: Knee arthroscopy Not Applicable

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arthroscopy
Knee arthroscopy + Exercise therapy
 Procedure: Knee arthroscopy
Knee arthroscopy within 4 weeks.
No Intervention: Exercise therapy
Exercise therapy alone


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. KOOS (Knee injury and Osteoarthritis Outcome Score) [ Time Frame: 3 month ]
  2. Tegner activity scale [ Time Frame: 12 month ]
  3. KOOS (Symptoms, ADL, Sport/rec, QOL subscores) [ Time Frame: 12 month ]
  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All (consecutive) patients referred to the orthopaedic department in Linköping for a suspected meniscal injury
  • Age:45-64 years old
  • No gonarthrosis (Ahlbäck=0) on standing radiographs

Exclusion Criteria:

  • Rheumatic disease
  • Patellofemoral arthrosis
  • Fibromyalgia
  • A knee or hip replacement
  • A neurologic disorder including stroke
  • A contraindication for an operation
  • Catching or locking for more than 2 seconds more than once a week
  • A permanent extension deficit
  • Patients who cannot understand instructions in Swedish
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): NCT01288768


Locations
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Sweden
Orthopaedic dept. University Hospital Linköping
Linköping, Sweden, 581 85
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
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Principal Investigator: Håkan Gauffin, MD PhD Orthopaedic dept. University Hospital, Linköping, Sweden.
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hakan Gauffin, MD PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01288768     History of Changes
Other Study ID Numbers: 2010/6-31
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013
Keywords provided by Hakan Gauffin, University Hospital, Linkoeping:
Meniscal injury
Knee arthroscopy
Middleaged
Functional outcome