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Clinical Trials/NCT01288768
NCT01288768
Completed
Not Applicable

Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?

University Hospital, Linkoeping1 site in 1 country150 target enrollmentMarch 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Meniscus Injury
Sponsor
University Hospital, Linkoeping
Enrollment
150
Locations
1
Primary Endpoint
KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale
Status
Completed
Last Updated
13 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
May 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Linkoeping
Responsible Party
Principal Investigator
Principal Investigator

Hakan Gauffin

MD PhD

University Hospital, Linkoeping

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • KOOS (Knee injury and Osteoarthritis Outcome Score)(3 month)
  • Tegner activity scale(12 month)
  • KOOS (Symptoms, ADL, Sport/rec, QOL subscores)(12 month)
  • Functional tests(3 month)

Study Sites (1)

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