NCT01288768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

3.2 years

First QC Date

January 26, 2011

Last Update Submit

May 2, 2013

Conditions

Chronic Meniscus Injury

Keywords

Meniscal injuryKnee arthroscopyMiddleagedFunctional outcome

Outcome Measures

Primary Outcomes (1)

  • KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale

    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 Outcomes (4)

  • KOOS (Knee injury and Osteoarthritis Outcome Score)

    3 month

  • Tegner activity scale

    12 month

  • KOOS (Symptoms, ADL, Sport/rec, QOL subscores)

    12 month

  • Functional tests

    3 month

Study Arms (2)

Arthroscopy

ACTIVE COMPARATOR

Knee arthroscopy + Exercise therapy

Procedure: Knee arthroscopy

Exercise therapy

NO INTERVENTION

Exercise therapy alone

Interventions

Knee arthroscopyPROCEDURE

Knee arthroscopy within 4 weeks.

Arthroscopy

Eligibility Criteria

Age45 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic dept. University Hospital Linköping

Linköping, 581 85, Sweden

Location

Related Publications (16)

  • 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. doi: 10.1093/rheumatology/40.6.631.

    PMID: 11426019BACKGROUND

  • 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.

    PMID: 18784100BACKGROUND

  • 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.

    PMID: 18397193BACKGROUND

  • Herrlin S, Hallander 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. doi: 10.1007/s00167-006-0243-2. Epub 2007 Jan 10.

    PMID: 17216272BACKGROUND

  • 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. doi: 10.1002/pri.137.

    PMID: 9782518BACKGROUND

  • 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. doi: 10.1186/1477-7525-2-38.

    PMID: 15279676BACKGROUND

  • 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. doi: 10.1111/j.1600-0838.1998.tb00465.x.

    PMID: 9863983BACKGROUND

  • 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. doi: 10.1053/jars.2000.4818.

    PMID: 10976123BACKGROUND

  • 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. doi: 10.1186/1477-7525-1-64.

    PMID: 14613558BACKGROUND

  • 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. doi: 10.1136/ard.2007.074088. Epub 2007 Aug 17.

    PMID: 17704069BACKGROUND

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

    PMID: 4028566BACKGROUND

  • 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. doi: 10.2522/ptj.20060372. Epub 2007 Nov 20.

    PMID: 18029391BACKGROUND

  • Sonesson S, Springer I, Yakob J, Hedevik H, Gauffin H, Kvist J. Knee Arthroscopic Surgery in Middle-Aged Patients With Meniscal Symptoms: A 10-Year Follow-up of a Prospective, Randomized Controlled Trial. Am J Sports Med. 2024 Jul;52(9):2250-2259. doi: 10.1177/03635465241255653.

    PMID: 39101738DERIVED

  • 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.

    PMID: 32047825DERIVED

  • 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.

    PMID: 28429967DERIVED

  • 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.

    PMID: 25086401DERIVED

Study Officials

  • Håkan Gauffin, MD PhD

    Orthopaedic dept. University Hospital, Linköping, Sweden.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 26, 2011

First Posted

February 2, 2011

Study Start

March 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

SE(1)