Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT01246167
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2010-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Proximal Humeral Fractures
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2010-11-15', 'studyFirstSubmitQcDate': '2010-11-22', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DASH', 'timeFrame': '6 months', 'description': 'to measure physical function and symptoms of the fractured shoulder'}, {'measure': 'DASH', 'timeFrame': '1 year', 'description': 'to measure physical function and symptoms of the fractured shoulder'}, {'measure': 'DASH', 'timeFrame': '2 year', 'description': 'to measure physical function and symptoms of the fractured shoulder'}], 'secondaryOutcomes': [{'measure': 'EQ-5D', 'timeFrame': '6 month', 'description': "Individual's general health related quality of life is measured with EQ-5D"}, {'measure': 'EQ-5D', 'timeFrame': '1 year', 'description': "Individual's general health related quality of life is measured with EQ-5D"}, {'measure': 'EQ-5D', 'timeFrame': '2 year', 'description': "Individual's general health related quality of life is measured with EQ-5D"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Proximal humerus fracture', 'conservative', 'locking plate', 'Philos', 'Hemiprosthesis'], 'conditions': ['Humeral Fractures, Proximal']}, 'referencesModule': {'references': [{'pmid': '22954329', 'type': 'BACKGROUND', 'citation': 'Launonen AP, Lepola V, Flinkkila T, Strandberg N, Ojanpera J, Rissanen P, Malmivaara A, Mattila VM, Elo P, Viljakka T, Laitinen M. Conservative treatment, plate fixation, or prosthesis for proximal humeral fracture. A prospective randomized study. BMC Musculoskelet Disord. 2012 Sep 7;13:167. doi: 10.1186/1471-2474-13-167.'}, {'pmid': '38015877', 'type': 'DERIVED', 'citation': 'Launonen AP, Sumrein BO, Reito A, Lepola V, Paloneva J, Berg HE, Fellander-Tsai L, Kask K, Rahnel T, Tootsi K, Martson A, Jonsson KB, Wolf O, Strom P, Dossing K, Ostergaard HK, Mechlenburg I, Mattila VM, Laitinen MK. Surgery with locking plate or hemiarthroplasty versus nonoperative treatment of 3-4-part proximal humerus fractures in older patients (NITEP): An open-label randomized trial. PLoS Med. 2023 Nov 28;20(11):e1004308. doi: 10.1371/journal.pmed.1004308. eCollection 2023 Nov.'}, {'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.'}, {'pmid': '31318863', 'type': 'DERIVED', 'citation': 'Launonen AP, Sumrein BO, Reito A, Lepola V, Paloneva J, Jonsson KB, Wolf O, Strom P, Berg HE, Fellander-Tsai L, Jansson KA, Fell D, Mechlenburg I, Dossing K, Ostergaard H, Martson A, Laitinen MK, Mattila VM; as the NITEP group. Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial. PLoS Med. 2019 Jul 18;16(7):e1002855. doi: 10.1371/journal.pmed.1002855. eCollection 2019 Jul.'}]}, 'descriptionModule': {'briefSummary': 'This trial is designed to compare head-to-head conservative with operative treatment in 2 stratum. Stratum 1: In 2 part fractures the comparison is between conservative treatment and operative treatment with plate fixation with Philos. Stratum 2: In multi-fragmented fractures (MFF) meaning 3 and 4 part fractures, the comparison is between conservative treatment, operative treatment with Philos plate and operative treatment with Epoca prosthesis. Subgroup analysis will be performed in an effort to obtain limit values for specific treatment of different age and fracture groups. A cost-effectiveness analysis and comparison between different treatment modalities will be carried out. The primary outcome measure will be the DASH score and the secondary outcome measure the EQ-5D value. Recruitment period is 3 years and follow-up 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low energy proximal humeral displaced (more than 1 cm or 45 degrees) 2 part fracture where fracture line emerges through the surgical (or anatomical) neck\n* Low energy proximal humeral displaced (more than 1 cm or 45 degrees) 3 or 4 part fracture\n\nExclusion Criteria:\n\n* Refuse to participate the study\n* Less than 60 years old\n* Non-independent\n* Dementia and/or institutionalized\n* Does no understand written and spoken guidance in either Finnish or Swedish\n* Pathological fracture or previous fracture in the same proximal humerus\n* Serious intoxicant dependent, eg. In first aid breathalyzer shows more than 2‰\n* Other operational injury in the same upper limb\n* Major nerve injury (eg. Complete radialis- or delta palsy)\n* Open fracture\n* Multi-trauma or -fractured patient\n* Fracture dislocation or head splitting fracture\n* Undisplaced fracture\n* Isolated tuberculum fracture\n* Fracture has no precondition to ossify by conservative treatment (no bony contact between fracture parts or the humeral shaft is in contact with the articular surface)\n* Treating surgeon considers patient unsuitable to attend the study on medical basis\n* Cuff-arthropathy'}, 'identificationModule': {'nctId': 'NCT01246167', 'acronym': 'TPHF', 'briefTitle': 'Treatment of Proximal Humeral Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'An International, Prospective, Randomized, Multicenter, Controlled Head-to-Head Comparison of Conservative, Plate Fixation and Prosthesis in Treatment of Displaced 2, 3, and 4 Part Fractures of Proximal Humerus of 60 Years and Older Patients', 'orgStudyIdInfo': {'id': 'R10127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative', 'description': 'Active physiotherapy and self-training', 'interventionNames': ['Other: Control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Philos locking plate', 'description': 'After operative treatment active physiotherapy and self-training', 'interventionNames': ['Device: Philos']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Epoca prosthesis', 'description': 'After operative treatment active physiotherapy and self-training', 'interventionNames': ['Device: Epoca']}], 'interventions': [{'name': 'Philos', 'type': 'DEVICE', 'description': 'Conservative treatment versus Philos locking plate in 2 part fracture group.\n\nConservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group.', 'armGroupLabels': ['Philos locking plate']}, {'name': 'Epoca', 'type': 'DEVICE', 'description': 'Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group', 'armGroupLabels': ['Epoca prosthesis']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'Conservative control group', 'armGroupLabels': ['Conservative']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Regionaalhaigla, PERH', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '40620', 'city': 'Jyväskylä', 'state': 'Central Finland', 'country': 'Finland', 'facility': 'Jyväskylä Central Hospital', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'zip': '33521', 'city': 'Tampere', 'state': 'Pirkanmaa', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Minna Laitinen, Docent', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Antti Launonen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Pekka Rissanen, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Tampere University'}, {'name': 'Johanna Ojanperä, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kuopio University Hospital'}, {'name': 'Vesa Lepola, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Timo Viljakka, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Ville M Mattila, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Juha Paloneva, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jyväskylä Central Hospital'}, {'name': 'Hans Berg, Docent', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska University Hospital'}, {'name': 'Karl-Åke Jansson, Docent', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska University Hospital'}, {'name': 'Kjeld Soballe, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Kaj Dossing, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Central Jutland Regional Hospital'}, {'name': 'Helle Ostergaard, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Central Jutland Regional Hospital'}, {'name': 'Inger Mechlenburg, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Aarhus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kuopio University Hospital', 'class': 'OTHER'}, {'name': 'Jyväskylä Central Hospital', 'class': 'OTHER'}, {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, {'name': 'Tampere University', 'class': 'OTHER'}, {'name': 'Academy of Finland', 'class': 'OTHER'}, {'name': 'Uppsala University Hospital', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Regionaalhaigla, Tallinn', 'class': 'UNKNOWN'}, {'name': 'Tartu University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Antti Launonen', 'investigatorAffiliation': 'Tampere University Hospital'}}}}