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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014