Clinical trial NCT01288768: Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?
Official title: Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Meniscus Injury
Keywords: Meniscal injury
Knee arthroscopy
Middleaged
Functional outcome
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2011-02-02
Enrollment: 150
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale
timeFrame: 12 month
Secondary outcomes:
measure: KOOS (Knee injury and Osteoarthritis Outcome Score)
timeFrame: 3 month
measure: Tegner activity scale
timeFrame: 12 month
measure: KOOS (Symptoms, ADL, Sport/rec, QOL subscores)
timeFrame: 12 month
measure: Functional tests
timeFrame: 3 month
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Orthopaedic dept. University Hospital Linköping
Study officials:
affiliation: Orthopaedic dept. University Hospital, Linköping, Sweden.
name: Håkan Gauffin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Sonesson S, Kvist J, Yakob J, Hedevik H, Gauffin H. Knee Arthroscopic Surgery in Middle-Aged Patients With Meniscal Symptoms: A 5-Year Follow-up of a Prospective, Randomized Study. Orthop J Sports Med. 2020 Jan 27;8(1):2325967119893920. doi: 10.1177/2325967119893920. eCollection 2020 Jan.
citation: Gauffin H, Sonesson S, Meunier A, Magnusson H, Kvist J. Knee Arthroscopic Surgery in Middle-Aged Patients With Meniscal Symptoms: A 3-Year Follow-up of a Prospective, Randomized Study. Am J Sports Med. 2017 Jul;45(9):2077-2084. doi: 10.1177/0363546517701431. Epub 2017 Apr 21.
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