Treatment of Proximal Humeral Fractures (TPHF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Tampere University Hospital
Sponsor:
Collaborators:
Oulu University Hospital
Kuopio University Hospital
Turku University Hospital
Jyväskylä Central Hospital
Karolinska University Hospital
University of Tampere
Information provided by (Responsible Party):
Antti Launonen, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01246167
First received: November 15, 2010
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Humeral Fractures, Proximal
Device: Philos
Device: Epoca
Other: Control group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • DASH [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    to measure physical function and symptoms of the fractured shoulder

  • DASH [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    to measure physical function and symptoms of the fractured shoulder

  • DASH [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    to measure physical function and symptoms of the fractured shoulder


Secondary Outcome Measures:
  • EQ-5D [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Individual's general health related quality of life is measured with EQ-5D

  • EQ-5D [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Individual's general health related quality of life is measured with EQ-5D

  • EQ-5D [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    Individual's general health related quality of life is measured with EQ-5D


Estimated Enrollment: 290
Study Start Date: January 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246167

Contacts
Contact: Antti Launonen, MD +358 3 311 69595 antti.launonen@pshp.fi

Locations
Finland
Jyväskylä Central Hospital Recruiting
Jyväskylä, Keski-Suomi, Finland, 40620
Contact: Juha Paloneva, MD PhD         
Sub-Investigator: Juha Paloneva, MD PhD         
Oulu University Hospital Recruiting
Oulu, Lappi, Finland, 90220
Contact: Tapio Flinkkilä, Docent       tapio.flinkkila@ppshp.fi   
Sub-Investigator: Tapio Flinkkilä, Docent         
Tampere University Hospital Recruiting
Tampere, Pirkanmaa, Finland, 33521
Contact: Antti Launonen, MD    +358 3 311 69595    antti.launonen@pshp.fi   
Sub-Investigator: Antti Launonen, MD         
Kuopio University Hospital Recruiting
Kuopio, Savo, Finland, 70200
Contact: Johanna Ojanperä, MD       johanna.ojanpera@kuh.fi   
Sub-Investigator: Johanna Ojanperä, MD         
Turku University Hospital Active, not recruiting
Turku, Finland, 20701
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Hans Berg, Docent         
Sub-Investigator: Hans Berg, Docent         
Sub-Investigator: Karl-Åke Jansson, Docent         
Sponsors and Collaborators
Tampere University Hospital
Oulu University Hospital
Kuopio University Hospital
Turku University Hospital
Jyväskylä Central Hospital
Karolinska University Hospital
University of Tampere
Investigators
Principal Investigator: Minna Laitinen, Docent Tampere University Hospital
Study Director: Antti Launonen, MD Tampere University Hospital
Study Chair: Pekka Rissanen, Professor University of Tampere
Study Chair: Tapio Flinkkilä, Docent Oulu University Hospital
Study Chair: Johanna Ojanperä, MD Kuopio University Hospital
Study Chair: Vesa Lepola, MD, PhD Hatanpää Hospital
Study Chair: Petra Elo, MD, PhD Tampere University Hospital
Study Chair: Timo Viljakka, MD Tampere University Hospital
Study Chair: Janne Iivanainen, MD Tampere University Hospital
Study Chair: Ville M Mattila, Docent Tampere University Hospital
Study Chair: Niko Strandberg, MD Turku 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
  More Information

Publications:
Responsible Party: Antti Launonen, MD, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01246167     History of Changes
Other Study ID Numbers: R10127
Study First Received: November 15, 2010
Last Updated: September 11, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Tampere University Hospital:
Proximal humerus fracture
conservative
locking plate
Philos
Epoca prosthesis

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on October 19, 2014