Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-01 @ 7:19 AM
Study NCT ID:
NCT00999193
Status:
TERMINATED
Last Update Posted:
2025-01-07
First Post:
2009-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006810', 'term': 'Humeral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062785', 'term': 'Hemiarthroplasty'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'whyStopped': 'Recruitment decline and research question getting outdated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-04', 'studyFirstSubmitDate': '2009-10-20', 'studyFirstSubmitQcDate': '2009-10-20', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain at rest Numeric Rating Scale 0-10 (NRS)', 'timeFrame': '6 weeks, 3 mo, 6 mo, 1 year, 2 years'}, {'measure': 'Pain in active motion NRS', 'timeFrame': '6 weeks, 3 mo, 6 mo, 1 year, 2 years'}, {'measure': 'Constant Score', 'timeFrame': '3 mo, 6 mo, 1 year, 2 years'}], 'secondaryOutcomes': [{'measure': 'Simple Shoulder Test (SST)', 'timeFrame': '3 mo, 6 mo, 1 year, 2 years'}, {'measure': 'Disabilities of the Arm, Shoulder and Hand (DASH)', 'timeFrame': '3 mo, 6 mo, 1 year, 2 years'}, {'measure': 'Quality of life assessed with 15D', 'timeFrame': '6 weeks, 3 mo, 6 mo, 1 year, 2 years'}, {'measure': 'Subjective satisfaction', 'timeFrame': '6 weeks, 3 mo, 6 mo, 1 year, 2 years'}, {'measure': 'Complications', 'timeFrame': '6 weeks, 3 mo, 6 mo, 1 year, 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Shoulder', 'Fracture', 'Locking Plate', 'Hemiarthroplasty', 'Conservative', 'Comminuted Proximal Humerus Fracture'], 'conditions': ['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': 'Fractures of the proximal humerus are common in elderly patients. The optimal treatment of comminuted, displaced fractures is subject to controversy, and the results of operative treatment have not been shown to be superior to conservative treatment. The aim of the study is to compare locking plate osteosynthesis versus treatment with fracture hemiarthroplasty versus conservative treatment in a randomised, controlled protocol. The results of treatment are measured at 6 weeks, 3 months, 6 months, 12 months and 24 months. Main outcome measures are Pain at rest and activity (NRSs) and functional assessment of the shoulder with Constant Score. Secondary outcome measures are Simple Shoulder test (SST), Disabilities of the Arm, Shoulder and Hand (DASH), quality of life assessment (15D), subjective patient satisfaction and costs. The study also has a cohort follow-up of the patiens who decline randomisation.\n\nThe recruitment target was 90 patients, but the study recruitment was stopped due to slow recruitment (too few patients presenting with eligibile injury to the hospital) at 60 patients in November 2019.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 years and older\n* Acute trauma: 1. randomisation (op vs cons) within 7 days of injury.\n* 3- or 4-part fracture with \\>5mm dislocation of the anatomic neck.\n\n * AO classification C1-2 for non-luxation fractures\n * AO classification C3 for luxation fractures\n\nExclusion Criteria:\n\n* Head Splitting fracture\n* Open fracture\n* Additional fractures in the shoulder region\n* Other injuries requiring surgical treatment\n* Clinically significant injury of the brachial plexus or vasculature\n* Pathological fracture associated with cancer\n* History of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc)\n* Rheumatoid Arthritis in the shoulder requiring active treatment\n* Reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc)\n* unwillingness to accept some of the treatment options.'}, 'identificationModule': {'nctId': 'NCT00999193', 'briefTitle': 'Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Helsinki'}, 'officialTitle': 'Effectiveness and Cost-effectiveness of Conservative and Operative Treatment of Three- and Four-part Fractures of the Proximal Humerus. A Nested Randomised Controlled Trial and Cohort Study', 'orgStudyIdInfo': {'id': 'HUS-428/13/03/02/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative Treatment', 'interventionNames': ['Other: Conservative treatment']}, {'type': 'EXPERIMENTAL', 'label': 'ORIF w. locking plate, no luxation', 'interventionNames': ['Procedure: locking plate, ORIF']}, {'type': 'EXPERIMENTAL', 'label': 'Hemiarthroplasty, no luxation', 'interventionNames': ['Procedure: Hemiarthroplasty']}], 'interventions': [{'name': 'locking plate, ORIF', 'type': 'PROCEDURE', 'description': 'Open reduction of the fracture (and GH joint), internal fixation with a locking plate. Tuberculum fragments are sutured to the plate with thick non-absorbable suture.', 'armGroupLabels': ['ORIF w. locking plate, no luxation']}, {'name': 'Hemiarthroplasty', 'type': 'PROCEDURE', 'description': 'Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.', 'armGroupLabels': ['Hemiarthroplasty, no luxation']}, {'name': 'Conservative treatment', 'type': 'OTHER', 'description': 'Immobilisation in a supporting brace for 3 weeks, then increasingly active rehabilitation program supported by a physiotherapist until 12 weeks of the injury.', 'armGroupLabels': ['Conservative Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Töölö Hospital Trauma Center, Helsinki University Central Hospital,', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Tuomas Lähdeoja, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Helsinki'}, {'name': 'Mika Paavola, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Helsinki'}, {'name': 'Jarkko Pajarinen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Helsinki'}, {'name': 'Seppo Koskinen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Helsinki'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Helsinki', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, {'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Tuomas Lahdeoja', 'investigatorAffiliation': 'University of Helsinki'}}}}