Completed

NCT Number: NCT01288768

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

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.

Completed

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Key information

Conditions

Chronic Meniscus Injury

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic dept. University Hospital Linköping

Linköping, 581 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Knee arthroscopy

Procedure

Knee arthroscopy within 4 weeks.

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)

Time frame: 3 month
Tegner activity scale

Time frame: 12 month
KOOS (Symptoms, ADL, Sport/rec, QOL subscores)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Feb 2, 2011
Registry last updated: May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.