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Chronic Meniscus InjuryNCT01288768

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

A study testing Knee arthroscopy in people with Chronic Meniscus Injury, run by University Hospital, Linkoeping at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 64 years
Conditions the study is for
Chronic Meniscus Injury
What is being tested?
Knee arthroscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteSweden
Study dates
Mar 2010to May 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Rheumatic disease
  • Patellofemoral arthrosis
  • Fibromyalgia
  • A knee or hip replacement
  • A neurologic disorder including stroke
  • A contraindication for an operation
Show all 9Show fewer
  • Catching or locking for more than 2 seconds more than once a week
  • A permanent extension deficit
  • Patients who cannot understand instructions in Swedish

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Orthopaedic dept. University Hospital Linköping

    Linköping, 581 85

Other trials in Sweden

About this study

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.

Read the 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.

Being tested
Knee arthroscopy
Keywords
Meniscal injury, Knee arthroscopy, Middleaged, Functional outcome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Knee arthroscopyProcedure or surgery

    Knee arthroscopy within 4 weeks.

Study groups in NCT01288768
Study groupRoleWhat they receive
ArthroscopyActive comparatorKnee arthroscopy + Exercise therapy
Receives: Procedure: Knee arthroscopy
Exercise therapyNo interventionExercise therapy alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 month

Secondary outcomes (4)

  1. KOOS (Knee injury and Osteoarthritis Outcome Score)

    Measured: 3 month

  2. Tegner activity scale

    Measured: 12 month

  3. KOOS (Symptoms, ADL, Sport/rec, QOL subscores)

    Measured: 12 month

  4. Functional tests

    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.

    Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2011 (estimated)
  2. Study startMar 2010
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01288768
Sponsor's protocol ID
2010/6-31
Status last verified
May 2013
First submitted
26 Jan 2011
Last updated
3 May 2013
Results posted
No
Data monitoring committee
No

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. doi: 10.1093/rheumatology/40.6.631.

    PubMed 11426019

  • 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.

    PubMed 18784100

  • 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.

    PubMed 18397193

  • 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.

    PubMed 17216272

  • 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.

    PubMed 9782518

  • 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.

    PubMed 15279676

  • 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.

    PubMed 9863983

  • 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.

    PubMed 10976123

  • 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.

    PubMed 14613558

  • 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.

    PubMed 17704069

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

    PubMed 4028566

  • 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.

    PubMed 18029391

  • Sonesson S, Kuster RP, Gauffin H, Kvist J. Long-term physical activity in middle-aged patients with meniscal symptoms: a 10-year follow-up of a randomised controlled trial comparing exercise therapy alone to knee arthroscopic surgery plus exercise therapy. BMC Musculoskelet Disord. 2025 Sep 23;26(1):854. doi: 10.1186/s12891-025-09151-4.

    PubMed 40988010

  • 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.

    PubMed 39101738

  • 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.

    PubMed 32047825

Questions about this trial

What is this clinical trial studying?

A study testing Knee arthroscopy in people with Chronic Meniscus Injury, run by University Hospital, Linkoeping at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01288768, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.

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