Clinical trial NCT01246167: Treatment of Proximal Humeral Fractures
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Humeral Fractures, Proximal
Keywords: Proximal humerus fracture
conservative
locking plate
Philos
Hemiprosthesis
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Kuopio University Hospital
name: Jyväskylä Central Hospital
name: Karolinska University Hospital
name: Tampere University
name: Academy of Finland
name: Uppsala University Hospital
name: Aarhus University Hospital
name: Regionaalhaigla, Tallinn
name: Tartu University Hospital
First posted: 2010-11-23
Enrollment: 250
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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
* Low energy proximal humeral displaced (more than 1 cm or 45 degrees) 3 or 4 part fracture

Exclusion Criteria:

* Refuse to participate the study
* 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

Primary outcomes:
measure: DASH
timeFrame: 6 months
measure: DASH
timeFrame: 1 year
measure: DASH
timeFrame: 2 year
Secondary outcomes:
measure: EQ-5D
timeFrame: 6 month
measure: EQ-5D
timeFrame: 1 year
measure: EQ-5D
timeFrame: 2 year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Tallinn
country: Estonia
facility: Regionaalhaigla, PERH
city: Jyväskylä
country: Finland
facility: Jyväskylä Central Hospital
state: Keski-Suomi
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Minna Laitinen, Docent
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Antti Launonen, MD
role: STUDY_DIRECTOR
affiliation: Tampere University
name: Pekka Rissanen, Professor
role: STUDY_CHAIR
affiliation: Kuopio University Hospital
name: Johanna Ojanperä, MD
role: STUDY_CHAIR
affiliation: Tampere 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: Jyväskylä Central Hospital
name: Juha Paloneva, MD PhD
role: STUDY_CHAIR
affiliation: Karolinska University Hospital
name: Hans Berg, Docent
role: STUDY_CHAIR
affiliation: Karolinska University Hospital
name: Karl-Åke Jansson, Docent
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Kjeld Soballe, Professor
role: STUDY_CHAIR
affiliation: Central Jutland Regional Hospital
name: Kaj Dossing, MD
role: STUDY_CHAIR
affiliation: Central Jutland Regional Hospital
name: Helle Ostergaard, Msc
role: STUDY_CHAIR
affiliation: University of Aarhus
name: Inger Mechlenburg, PhD
role: STUDY_CHAIR
References:
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.
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.
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.