Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2026-01-07 @ 3:31 PM
Study NCT ID:
NCT02073695
Status:
TERMINATED
Last Update Posted:
2019-07-18
First Post:
2014-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012784', 'term': 'Shoulder Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'A publication released shortly after start indicating intervention not always beneficial. Fewer surgical cased thereafter.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-17', 'studyFirstSubmitDate': '2014-02-21', 'studyFirstSubmitQcDate': '2014-02-26', 'lastUpdatePostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxford score', 'timeFrame': '1 Year post surgery', 'description': 'Patients subjective assessment of pain and Activities of Daily Living (ADL) impairment. The Oxford Shoulder Questionnaire has been shown to correlate well with both the Constant Score and the SF36 assessment and to be sensitive to surgical intervention. The Oxford Shoulder Questionnaire accumulates to a total score with a maximum of value of 60, in which four pain related questions make up 33% of this total whilst the remaining 67% is derived from eight ADL related questions. The highest scores are attributed to the worst outcomes in the Oxford Shoulder Questionnaire'}, {'measure': 'DASH - the Disabilities of the Arm, Shoulder and Hand', 'timeFrame': '1 year post surgery', 'description': 'DASH Scoring system was developed to assess the level of disability for any patient with any condition affecting the upper limb by covering domains including symptoms, physical function and psychological function'}], 'secondaryOutcomes': [{'measure': 'Range of movement(flexion, extension, abduction, external and internal rotation)', 'timeFrame': '6 weeks, 3 months and 1 year', 'description': 'Assessed by Physiotherapists. Measurement will be performed using a goniometer to accurately assess range of movement'}, {'measure': 'SF-12 Score', 'timeFrame': '1 Year post surgery', 'description': 'This survey form has been shown to yield summary physical and mental health outcome scores'}, {'measure': 'Range of movement (flexion, extension, abduction and internal rotation)', 'timeFrame': '6 weeks, 6 months and 1 year', 'description': 'Conducted by physiotherapists. Measured using a goniometer to accurately assess range of movement'}, {'measure': 'Time to union of fracture', 'timeFrame': '6 weeks and 3 Months', 'description': 'X-Rays taken'}, {'measure': 'Return to work post surgery', 'timeFrame': '1 year follow up'}, {'measure': 'Re-operations and Complications', 'timeFrame': 'Throughout 1st year as applicable at outpatient appointments', 'description': 'Documented at various outpatient appointments'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Proximal humeral fracture', 'Shoulder', 'Orthopaedics', 'Neutral rotation brace', 'Polysling'], 'conditions': ['Proximal Humeral Fracture']}, 'referencesModule': {'references': [{'pmid': '35727196', 'type': 'DERIVED', 'citation': 'Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.'}]}, 'descriptionModule': {'briefSummary': "Research question:\n\nDo patients using a neutral rotation brace post surgery have improved functional outcome and external rotation of the shoulder compared to current best practice using a polysling holding the proximal humerus in internal rotation?\n\nPrimary objectives:\n\nTo compare post-operative functional outcome scores obtained at 6 weeks, 9 weeks, 3 months and 1 year. (Scores at 6 weeks and 3 months in clinical review and postal scores at 9 weeks and 1 year) between patients held in neutral versus current standard rotation. These will be compared to scores taken pre-operatively.\n\nBenefits:\n\nThere may be no extra benefits to patients from this trial however the results from the trial will help improve treatment for future patients at this hospital, and others across the country.\n\nRisks/disadvantages:\n\nThe operation is the same in both groups studied, the study is investigating the use of the two different slings. The post-operative treatment is also the same, and all patients on the trial will receive the same amount of physiotherapy. It isn't anticipated that there will be any additional risk from this trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Proximal humeral fractures requiring operative intervention with extramedullary plate fixation (i.e. fractures displaced by 1cm and/or angulated by 45 degrees or more)\n* Age over 18 years of age\n* Patient able to give informed consent\n\nExclusion Criteria:\n\n* Patients having intra-operative findings to complete Pectoralis major rupture or if operative exposure requires complete Pectoralis major tenotomy. (These patients need to be held in internal rotation with a standard polysling to allow healing of the Pectoralis major tendon)\n* Patients under 18 years of age\n* Patients unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT02073695', 'acronym': 'ROTATE', 'briefTitle': 'Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace', 'organization': {'class': 'OTHER', 'fullName': 'Torbay and South Devon NHS Foundation Trust'}, 'officialTitle': 'Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace', 'orgStudyIdInfo': {'id': '13/01/049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Neutral Rotation Brace', 'description': 'Neutral Rotation Brace', 'interventionNames': ['Procedure: Operative procedure to fix proximal humeral', 'Device: Neutral Rotation Brace', 'Other: Physiotherapy review', 'Other: Functional outcome forms filled in', 'Other: Postal functional outcome scores', 'Other: Post-operative Radiographs']}, {'type': 'OTHER', 'label': 'Standard polysling (Current practice)', 'description': 'Standard polysling (Current practice)', 'interventionNames': ['Procedure: Operative procedure to fix proximal humeral', 'Device: Neutral Rotation Brace', 'Other: Physiotherapy review', 'Other: Functional outcome forms filled in', 'Other: Postal functional outcome scores', 'Other: Post-operative Radiographs']}], 'interventions': [{'name': 'Operative procedure to fix proximal humeral', 'type': 'PROCEDURE', 'description': 'Operative fixation by the shoulder team at Torbay Hospital', 'armGroupLabels': ['Neutral Rotation Brace', 'Standard polysling (Current practice)']}, {'name': 'Neutral Rotation Brace', 'type': 'DEVICE', 'description': 'Performed at the end of the surgical procedure at Torbay Hospital', 'armGroupLabels': ['Neutral Rotation Brace', 'Standard polysling (Current practice)']}, {'name': 'Physiotherapy review', 'type': 'OTHER', 'description': 'Physiotherapy review on day of surgery, and post-surgery at 6 weeks, 3 months and 1 year.', 'armGroupLabels': ['Neutral Rotation Brace', 'Standard polysling (Current practice)']}, {'name': 'Functional outcome forms filled in', 'type': 'OTHER', 'otherNames': ['Oxford', 'DASH', 'SF-12'], 'armGroupLabels': ['Neutral Rotation Brace', 'Standard polysling (Current practice)']}, {'name': 'Postal functional outcome scores', 'type': 'OTHER', 'description': 'Sent to patient at 9 weeks post surgery', 'armGroupLabels': ['Neutral Rotation Brace', 'Standard polysling (Current practice)']}, {'name': 'Post-operative Radiographs', 'type': 'OTHER', 'description': 'Performed at 6 weeks and 3 months at shoulder clinic appointment at Torbay Hospital', 'armGroupLabels': ['Neutral Rotation Brace', 'Standard polysling (Current practice)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TQ2 7AA', 'city': 'Torquay', 'country': 'United Kingdom', 'facility': 'Torbay District General Hospital', 'geoPoint': {'lat': 50.46198, 'lon': -3.52522}}], 'overallOfficials': [{'name': 'Veronica Conboy, FRCS (Orth)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Devon Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Torbay and South Devon NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}