Treatment of Proximal Humeral Fractures (TPHF)

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

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.

Study Overview

• Status: Completed
• Conditions: Humeral Fractures, Proximal
• Intervention / Treatment: Other: Control group; Device: Philos; Device: Epoca

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus University Hospital
• Estonia
  • Tallinn, Estonia
    • Regionaalhaigla, PERH
• Finland
  • Keski-Suomi
    • Jyväskylä, Keski-Suomi, Finland, 40620
      • Jyväskylä Central Hospital
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33521
      • Tampere University Hospital
• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital
  • Uppsala, Sweden
    • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conservative; Active physiotherapy and self-training	Other: Control group; Conservative control group
Active Comparator: Philos locking plate; After operative treatment active physiotherapy and self-training	Device: Philos; Conservative treatment versus Philos locking plate in 2 part fracture group. Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group.
Active Comparator: Epoca prosthesis; After operative treatment active physiotherapy and self-training	Device: Epoca; Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DASH	to measure physical function and symptoms of the fractured shoulder	6 months
DASH	to measure physical function and symptoms of the fractured shoulder	1 year
DASH	to measure physical function and symptoms of the fractured shoulder	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D	Individual's general health related quality of life is measured with EQ-5D	6 month
EQ-5D	Individual's general health related quality of life is measured with EQ-5D	1 year
EQ-5D	Individual's general health related quality of life is measured with EQ-5D	2 year

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Karolinska University Hospital; Aarhus University Hospital; Kuopio University Hospital; Tampere University; Tartu University Hospital; Uppsala University Hospital; Academy of Finland; Jyväskylä Central Hospital; Regionaalhaigla, Tallinn
• Investigators: Principal Investigator: Minna Laitinen, Docent, Tampere University Hospital; Study Director: Antti Launonen, MD, Tampere University Hospital; Study Chair: Pekka Rissanen, Professor, Tampere University; Study Chair: Johanna Ojanperä, MD, Kuopio University Hospital; Study Chair: Vesa Lepola, MD, PhD, Tampere University Hospital; Study Chair: Timo Viljakka, MD, Tampere University Hospital; Study Chair: Ville M Mattila, Professor, Tampere University Hospital; Study Chair: Juha Paloneva, MD PhD, Jyväskylä Central Hospital; Study Chair: Hans Berg, Docent, Karolinska University Hospital; Study Chair: Karl-Åke Jansson, Docent, Karolinska University Hospital; Study Chair: Kjeld Soballe, Professor, Aarhus University Hospital; Study Chair: Kaj Dossing, MD, Central Jutland Regional Hospital; Study Chair: Helle Ostergaard, Msc, Central Jutland Regional Hospital; Study Chair: Inger Mechlenburg, PhD, University of Aarhus

Publications and helpful links

General Publications

• 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, 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, 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: November 22, 2010
• First Posted (Estimate): November 23, 2010

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: conservative; Proximal humerus fracture; Philos; locking plate; Hemiprosthesis
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: R10127