Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-29 @ 8:26 PM
Study NCT ID:
NCT01288768
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2011-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-02', 'studyFirstSubmitDate': '2011-01-26', 'studyFirstSubmitQcDate': '2011-02-01', 'lastUpdatePostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale', 'timeFrame': '12 month', 'description': '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.'}], 'secondaryOutcomes': [{'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', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Meniscal injury', 'Knee arthroscopy', 'Middleaged', 'Functional outcome'], 'conditions': ['Chronic Meniscus Injury']}, 'referencesModule': {'references': [{'pmid': '11426019', 'type': 'BACKGROUND', 'citation': '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': '18784100', 'type': 'BACKGROUND', 'citation': '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': '18397193', 'type': 'BACKGROUND', 'citation': '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': '17216272', 'type': 'BACKGROUND', 'citation': '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': '9782518', 'type': 'BACKGROUND', 'citation': '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': '15279676', 'type': 'BACKGROUND', 'citation': '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': '9863983', 'type': 'BACKGROUND', 'citation': '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': '10976123', 'type': 'BACKGROUND', 'citation': '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': '14613558', 'type': 'BACKGROUND', 'citation': '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': '17704069', 'type': 'BACKGROUND', 'citation': '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': '4028566', 'type': 'BACKGROUND', 'citation': 'Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.'}, {'pmid': '18029391', 'type': 'BACKGROUND', 'citation': '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': '39101738', 'type': 'DERIVED', 'citation': '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': '32047825', 'type': 'DERIVED', '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.'}, {'pmid': '28429967', 'type': 'DERIVED', '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.'}, {'pmid': '25086401', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All (consecutive) patients referred to the orthopaedic department in Linköping for a suspected meniscal injury\n* Age:45-64 years old\n* No gonarthrosis (Ahlbäck=0) on standing radiographs\n\nExclusion Criteria:\n\n* Rheumatic disease\n* Patellofemoral arthrosis\n* Fibromyalgia\n* A knee or hip replacement\n* A neurologic disorder including stroke\n* A contraindication for an operation\n* Catching or locking for more than 2 seconds more than once a week\n* A permanent extension deficit\n* Patients who cannot understand instructions in Swedish'}, 'identificationModule': {'nctId': 'NCT01288768', 'briefTitle': 'Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'officialTitle': 'Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?', 'orgStudyIdInfo': {'id': '2010/6-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arthroscopy', 'description': 'Knee arthroscopy + Exercise therapy', 'interventionNames': ['Procedure: Knee arthroscopy']}, {'type': 'NO_INTERVENTION', 'label': 'Exercise therapy', 'description': 'Exercise therapy alone'}], 'interventions': [{'name': 'Knee arthroscopy', 'type': 'PROCEDURE', 'description': 'Knee arthroscopy within 4 weeks.', 'armGroupLabels': ['Arthroscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '581 85', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Orthopaedic dept. University Hospital Linköping', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Håkan Gauffin, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopaedic dept. University Hospital, Linköping, Sweden.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Hakan Gauffin', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}