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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hakan Gauffin, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01288768
First received: January 26, 2011
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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 Intervention
Chronic Meniscus Injury
Procedure: Knee arthroscopy

Study Type: Interventional
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?

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 150
Study Start Date: March 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288768

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

Publications:

Responsible Party: Hakan Gauffin, MD PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01288768     History of Changes
Other Study ID Numbers: 2010/6-31
Study First Received: January 26, 2011
Last Updated: May 2, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by University Hospital, Linkoeping:
Meniscal injury
Knee arthroscopy
Middleaged
Functional outcome

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on April 20, 2014