Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-03 @ 8:43 PM
Study NCT ID:
NCT00852657
Status:
COMPLETED
Last Update Posted:
2023-03-15
First Post:
2009-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2009-02-26', 'studyFirstSubmitQcDate': '2009-02-26', 'lastUpdatePostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Constant score', 'timeFrame': 'baseline, 6 months, 1, 2, 5, 10, 15 years'}], 'secondaryOutcomes': [{'measure': 'self report section of the American Shoulder and Elbow Surgeons score (ASES)', 'timeFrame': 'baseline, 6 months, 1, 2, 5, 10, 15 years'}, {'measure': 'Short Form 36 Health Survey (SF-36)', 'timeFrame': 'baseline, 6 months, 1, 2, 5, 10, 15 years'}, {'measure': 'Patient satisfaction', 'timeFrame': '1, 2, 5, 10, 15 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rotator cuff tear', 'surgical repair', 'Physiotherapy', 'Treatment benefit', 'Surgery'], 'conditions': ['Rotator Cuff Tear']}, 'referencesModule': {'references': [{'pmid': '20044684', 'type': 'RESULT', 'citation': 'Moosmayer S, Lund G, Seljom U, Svege I, Hennig T, Tariq R, Smith HJ. Comparison between surgery and physiotherapy in the treatment of small and medium-sized tears of the rotator cuff: A randomised controlled study of 103 patients with one-year follow-up. J Bone Joint Surg Br. 2010 Jan;92(1):83-91. doi: 10.1302/0301-620X.92B1.22609.'}, {'pmid': '25232074', 'type': 'RESULT', 'citation': 'Moosmayer S, Lund G, Seljom US, Haldorsen B, Svege IC, Hennig T, Pripp AH, Smith HJ. Tendon repair compared with physiotherapy in the treatment of rotator cuff tears: a randomized controlled study in 103 cases with a five-year follow-up. J Bone Joint Surg Am. 2014 Sep 17;96(18):1504-14. doi: 10.2106/JBJS.M.01393.'}, {'pmid': '31220021', 'type': 'RESULT', 'citation': 'Moosmayer S, Lund G, Seljom US, Haldorsen B, Svege IC, Hennig T, Pripp AH, Smith HJ. At a 10-Year Follow-up, Tendon Repair Is Superior to Physiotherapy in the Treatment of Small and Medium-Sized Rotator Cuff Tears. J Bone Joint Surg Am. 2019 Jun 19;101(12):1050-1060. doi: 10.2106/JBJS.18.01373.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare treatment benefits from surgical treatment by tendon repair and from physiotherapy for small and medium-sized rotator cuff tears.', 'detailedDescription': 'Surgical treatment by tendon repair or physiotherapy are accepted treatment options for small and medium-sized rotator cuff tears, but have never been compared in randomised, controlled studies.\n\nIn this study, patients presenting clinical signs together with imaging findings (MRI and sonography) for a full-thickness rotator cuff tear will be randomly allocated to surgery (tendon repair) or physiotherapy. Outcome measuring will be performed by the Constant score, the self report section of the American Shoulder and Elbow Surgeons score (ASES), the Short Form 36 Health Survey (SF-36) and subscores for shoulder motion, pain, strength and patient satisfaction. Scores will be taken at baseline and after 6 months,1, 2, 5, 10 and 15 years by a blinded assessor. All operated shoulders will be controlled by MRI after one year. Patients with no effect from physiotherapy after at least 15 treatment sessions will be offered secondary surgical treatment, and scoring results from last follow-up before surgery will be carried forward to analysis, according to an intention to treat principle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical history and imaging findings of a rotator cuff tear\n\nExclusion Criteria:\n\n* Presence of other local or systemic diseases influencing on shoulder function\n* History of earlier rotator cuff surgery\n* Medical contraindications for surgery'}, 'identificationModule': {'nctId': 'NCT00852657', 'briefTitle': 'Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff', 'organization': {'class': 'OTHER', 'fullName': 'Vestre Viken Hospital Trust'}, 'officialTitle': 'Comparison of Surgical Treatment by Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff', 'orgStudyIdInfo': {'id': '430-04149 (REK)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical treatment', 'description': 'Open or mini-open tendon repair with acromioplasty', 'interventionNames': ['Procedure: Tendon repair with acromioplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physiotherapy', 'description': 'Physiotherapy by exercises', 'interventionNames': ['Procedure: Physiotherapy']}], 'interventions': [{'name': 'Tendon repair with acromioplasty', 'type': 'PROCEDURE', 'description': 'Open or mini-open tendon repair in combination with an acromioplasty and eventually a tenodesis of the long head of the biceps', 'armGroupLabels': ['Surgical treatment']}, {'name': 'Physiotherapy', 'type': 'PROCEDURE', 'description': 'According to a rehabilitation program which was established prior to study start.', 'armGroupLabels': ['Physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1306', 'city': 'Sandvika', 'country': 'Norway', 'facility': "Martina Hansen's Hospital", 'geoPoint': {'lat': 64.46377, 'lon': 13.59125}}], 'overallOfficials': [{'name': 'Stefan Moosmayer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vestre Viken Hospital Trust'}, {'name': 'Hans-Joergen Smith, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Oslo, Rikshospitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vestre Viken Hospital Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Stefan Moosmayer', 'investigatorAffiliation': 'Vestre Viken Hospital Trust'}}}}