Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
250 participants
INTERVENTIONAL
2011-01-31
2019-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Conservative
Active physiotherapy and self-training
Control group
Conservative control group
Philos locking plate
After operative treatment active physiotherapy and self-training
Philos
Conservative treatment versus Philos locking plate in 2 part fracture group.
Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group.
Epoca prosthesis
After operative treatment active physiotherapy and self-training
Epoca
Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group
Interventions
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Philos
Conservative treatment versus Philos locking plate in 2 part fracture group.
Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group.
Epoca
Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group
Control group
Conservative control group
Eligibility Criteria
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Inclusion Criteria
* Low energy proximal humeral displaced (more than 1 cm or 45 degrees) 3 or 4 part fracture
Exclusion Criteria
* Less than 60 years old
* Non-independent
* Dementia and/or institutionalized
* Does no understand written and spoken guidance in either Finnish or Swedish
* Pathological fracture or previous fracture in the same proximal humerus
* Serious intoxicant dependent, eg. In first aid breathalyzer shows more than 2‰
* Other operational injury in the same upper limb
* Major nerve injury (eg. Complete radialis- or delta palsy)
* Open fracture
* Multi-trauma or -fractured patient
* Fracture dislocation or head splitting fracture
* Undisplaced fracture
* Isolated tuberculum fracture
* 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)
* Treating surgeon considers patient unsuitable to attend the study on medical basis
* Cuff-arthropathy
60 Years
100 Years
ALL
No
Sponsors
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Kuopio University Hospital
OTHER
Jyväskylä Central Hospital
OTHER
Karolinska University Hospital
OTHER
Tampere University
OTHER
Academy of Finland
OTHER
Uppsala University Hospital
OTHER
Aarhus University Hospital
OTHER
Regionaalhaigla, Tallinn
UNKNOWN
Tartu University Hospital
OTHER
Tampere University Hospital
OTHER
Responsible Party
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Antti Launonen
MD
Principal Investigators
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Minna Laitinen, Docent
Role: PRINCIPAL_INVESTIGATOR
Tampere University Hospital
Antti Launonen, MD
Role: STUDY_DIRECTOR
Tampere University Hospital
Pekka Rissanen, Professor
Role: STUDY_CHAIR
Tampere University
Johanna Ojanperä, MD
Role: STUDY_CHAIR
Kuopio University Hospital
Vesa Lepola, MD, PhD
Role: STUDY_CHAIR
Tampere University Hospital
Timo Viljakka, MD
Role: STUDY_CHAIR
Tampere University Hospital
Ville M Mattila, Professor
Role: STUDY_CHAIR
Tampere University Hospital
Juha Paloneva, MD PhD
Role: STUDY_CHAIR
Jyväskylä Central Hospital
Hans Berg, Docent
Role: STUDY_CHAIR
Karolinska University Hospital
Karl-Åke Jansson, Docent
Role: STUDY_CHAIR
Karolinska University Hospital
Kjeld Soballe, Professor
Role: STUDY_CHAIR
Aarhus University Hospital
Kaj Dossing, MD
Role: STUDY_CHAIR
Central Jutland Regional Hospital
Helle Ostergaard, Msc
Role: STUDY_CHAIR
Central Jutland Regional Hospital
Inger Mechlenburg, PhD
Role: STUDY_CHAIR
University of Aarhus
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Regionaalhaigla, PERH
Tallinn, , Estonia
Jyväskylä Central Hospital
Jyväskylä, Central Finland, Finland
Tampere University Hospital
Tampere, Pirkanmaa, Finland
Karolinska University Hospital
Stockholm, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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R10127
Identifier Type: -
Identifier Source: org_study_id
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