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

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ClinicalTrials.gov Identifier: NCT01288768

Recruitment Status : Completed

First Posted : February 2, 2011

Last Update Posted : May 3, 2013

Sponsor:

Information provided by (Responsible Party):

Hakan Gauffin, University Hospital, Linkoeping

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Meniscus Injury	Procedure: Knee arthroscopy	Not Applicable

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
Official Title:	Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?
Study Start Date :	March 2010
Actual Primary Completion Date :	May 2013
Actual Study Completion Date :	May 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	45 Years to 64 Years (Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

Englund M, Roos EM, Roos HP, Lohmander LS. Patient-relevant outcomes fourteen years after meniscectomy: influence of type of meniscal tear and size of resection. Rheumatology (Oxford). 2001 Jun;40(6):631-9.

Englund M, Guermazi A, Gale D, Hunter DJ, Aliabadi P, Clancy M, Felson DT. Incidental meniscal findings on knee MRI in middle-aged and elderly persons. N Engl J Med. 2008 Sep 11;359(11):1108-15. doi: 10.1056/NEJMoa0800777.

Ericsson YB, Dahlberg LE, Roos EM. Effects of functional exercise training on performance and muscle strength after meniscectomy: a randomized trial. Scand J Med Sci Sports. 2009 Apr;19(2):156-65. doi: 10.1111/j.1600-0838.2008.00794.x. Epub 2008 Apr 6.

Herrlin S, Hållander M, Wange P, Weidenhielm L, Werner S. Arthroscopic or conservative treatment of degenerative medial meniscal tears: a prospective randomised trial. Knee Surg Sports Traumatol Arthrosc. 2007 Apr;15(4):393-401. Epub 2007 Jan 10.

Larsson AC, Petersson I, Ekdahl C. Functional capacity and early radiographic osteoarthritis in middle-aged people with chronic knee pain. Physiother Res Int. 1998;3(3):153-63.

Paradowski PT, Englund M, Roos EM, Lohmander LS. Similar group mean scores, but large individual variations, in patient-relevant outcomes over 2 years in meniscectomized subjects with and without radiographic knee osteoarthritis. Health Qual Life Outcomes. 2004 Jul 27;2:38.

Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee injury and Osteoarthritis Outcome Score (KOOS)--validation of a Swedish version. Scand J Med Sci Sports. 1998 Dec;8(6):439-48.

Roos EM, Roos HP, Ryd L, Lohmander LS. Substantial disability 3 months after arthroscopic partial meniscectomy: A prospective study of patient-relevant outcomes. Arthroscopy. 2000 Sep;16(6):619-26.

Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. Review.

Roos EM, Bremander AB, Englund M, Lohmander LS. Change in self-reported outcomes and objective physical function over 7 years in middle-aged subjects with or at high risk of knee osteoarthritis. Ann Rheum Dis. 2008 Apr;67(4):505-10. Epub 2007 Aug 17.

Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.

Wood L, Peat G, Thomas E, Hay EM, Sim J. Associations between physical examination and self-reported physical function in older community-dwelling adults with knee pain. Phys Ther. 2008 Jan;88(1):33-42. Epub 2007 Nov 20.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Gauffin H, Tagesson S, Meunier A, Magnusson H, Kvist J. Knee arthroscopic surgery is beneficial to middle-aged patients with meniscal symptoms: a prospective, randomised, single-blinded study. Osteoarthritis Cartilage. 2014 Nov;22(11):1808-16. doi: 10.1016/j.joca.2014.07.017. Epub 2014 Jul 30.


Responsible Party:	Hakan Gauffin, MD PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:	NCT01288768 History of Changes
Other Study ID Numbers:	2010/6-31
First Posted:	February 2, 2011 Key Record Dates
Last Update Posted:	May 3, 2013
Last Verified:	May 2013

Keywords provided by Hakan Gauffin, University Hospital, Linkoeping:


Meniscal injury Knee arthroscopy Middleaged Functional outcome

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