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

May 2, 2013 updated by: Hakan Gauffin, University Hospital, Linkoeping
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linköping, Sweden, 581 85
        • Orthopaedic dept. University Hospital Linköping

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS (Knee injury and Osteoarthritis Outcome Score)
Time Frame: 3 month
3 month
Tegner activity scale
Time Frame: 12 month
12 month
KOOS (Symptoms, ADL, Sport/rec, QOL subscores)
Time Frame: 12 month
12 month
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.
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Linkoeping

Investigators

  • Principal Investigator: Håkan Gauffin, MD PhD, Orthopaedic dept. University Hospital, Linköping, Sweden.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

February 1, 2011

First Posted (Estimate)

February 2, 2011

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 2, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010/6-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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