Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-03-11 @ 9:44 AM
Study NCT ID:
NCT02836366
Status:
COMPLETED
Last Update Posted:
2019-06-07
First Post:
2016-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targon PH+ Follow-Up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012784', 'term': 'Shoulder Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-06', 'studyFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2016-07-18', 'lastUpdatePostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Capacity', 'timeFrame': '24 months', 'description': 'The DASH score (Disabilities of the Arm, Shoulder, and Hand) will be used to determine the recovery of functional capacity. It provides a summary of the responses on a scale of 0 (no disability) to 100 (severe disability)'}], 'secondaryOutcomes': [{'measure': 'Level of pain', 'timeFrame': '3, 12 and 24 months', 'description': '10-point Visual Analogue Scale (VAS) from no pain (0) to most extreme pain imaginable (10)'}, {'measure': 'Patient satisfaction', 'timeFrame': '24 months', 'description': '4 point scale: very satisfied, satisfied, unsatisfied, very unsatisfied'}, {'measure': 'Shoulder Function', 'timeFrame': '12 months, 24 months', 'description': 'Shoulder function outcome is measured with the Constant-Murley score, this score system combines shoulder function tests (65 points) with a subjective evaluation of the patients (35 points) including activities of daily living, level of work'}, {'measure': 'Radiological outcome (only if it could be raised in clinical standard)', 'timeFrame': '24 months', 'description': 'The X-rays are examined regarding adverse events as screw perforation, screw breakage, cut-out, re-dislocation of the fracture'}, {'measure': 'Adverse Events', 'timeFrame': '24 months', 'description': 'Rate of Adverse Events, for example secondary interventions (revisions) that occur within the follow-up period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Proximal humerus', 'Fracture', 'Nailing'], 'conditions': ['Shoulder Fractures']}, 'descriptionModule': {'briefSummary': 'With this study results of the Targon® PH+ nail, developed for the treatment of humeral head fractures, will be investigated clinically, radiological evaluation is optional. The primary objective of this study is to examine the effect of a plating treatment on the speed of recovery of functional capacity in adult patients. Secondary aims are to examine the level of pain, patient satisfaction, shoulder function, quality of life, radiological evaluation and complications.\n\nTargon PH+ is CE certified. The study is a non-interventional cohort study sponsored by Aesculap'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: - patients with a three- or four-fragment-fracture of the proximal humerus, with dislocation on X-ray\n\n* older than 60 years of age\n* written and signed patient consent\n\nExclusion Criteria: - Fractures more than 14 days old\n\n* multiple comorbidity\n* multitrauma (Injury Severity Score \\> 15)\n* prev. surgery on the injured shoulder\n* severely deranged function caused by a previous disease head-split proximal humerus fracture\n* combined humerus head and shaft fractures\n* pseudarthroses\n* crushed head cap of the humerus head (AO 11 C3 fractures)\n* isolated avulsion fracture of a tuberosity\n* unwillingness or inability to follow protocol instructions and study requirements (follow-up visits)\n* no signed informed consent\n* treatment not in line with Instructions for Use (IfU)'}, 'identificationModule': {'nctId': 'NCT02836366', 'briefTitle': 'Targon PH+ Follow-Up', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Prospective Cohort Study of Proximal Humeral Fractures Treated With Targon® PH+', 'orgStudyIdInfo': {'id': 'AAG-O-H-1536'}}, 'contactsLocationsModule': {'locations': [{'zip': '90471', 'city': 'Nuremberg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum Nürnberg Süd', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}], 'overallOfficials': [{'name': 'Hermann Josef Bail, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Nürnberg Süd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}