NCT01246167

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

8.8 years

First QC Date

November 15, 2010

Last Update Submit

March 9, 2020

Conditions

Humeral Fractures, Proximal

Keywords

Proximal humerus fractureconservativelocking platePhilosHemiprosthesis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • EQ-5D

    6 month

  • EQ-5D

    1 year

  • EQ-5D

    2 year

Study Arms (3)

Conservative

ACTIVE COMPARATOR

Active physiotherapy and self-training

Other: Control group

Philos locking plate

ACTIVE COMPARATOR

After operative treatment active physiotherapy and self-training

Device: Philos

Epoca prosthesis

ACTIVE COMPARATOR

After operative treatment active physiotherapy and self-training

Device: Epoca

Interventions

PhilosDEVICE

Conservative treatment versus Philos locking plate in 2 part fracture group. Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group.

Philos locking plate
EpocaDEVICE

Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group

Epoca prosthesis
Control groupOTHER

Conservative control group

Conservative

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Aarhus University Hospital

Aarhus, Denmark

Location

Regionaalhaigla, PERH

Tallinn, Estonia

Location

Jyväskylä Central Hospital

Jyväskylä, Central Finland, 40620, Finland

Location

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (4)

  • 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: 22954329BACKGROUND

  • 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: 38015877DERIVED

  • 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: 35727196DERIVED

  • 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.

    PMID: 31318863DERIVED

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Minna Laitinen, Docent

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

  • Antti Launonen, MD

    Tampere University Hospital

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 23, 2010

Study Start

January 1, 2011

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

SE(2)DK(1)ES(1)FI(2)