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Treatment of Proximal Humeral Fractures (TPHF)

This study is currently recruiting participants.
Verified October 2017 by Antti Launonen, Tampere University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01246167
First Posted: November 23, 2010
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Kuopio University Hospital
Jyväskylä Central Hospital
Karolinska University Hospital
University of Tampere
Academy of Finland
Uppsala University Hospital
Aarhus University Hospital
Regionaalhaigla, Tallinn
Tartu University Hospital
Information provided by (Responsible Party):
Antti Launonen, Tampere University Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Antti Launonen, Tampere University Hospital:

Primary Outcome Measures:
  • DASH [ Time Frame: 6 months ]
    to measure physical function and symptoms of the fractured shoulder

  • DASH [ Time Frame: 1 year ]
    to measure physical function and symptoms of the fractured shoulder

  • DASH [ Time Frame: 2 year ]
    to measure physical function and symptoms of the fractured shoulder


Secondary Outcome Measures:
  • EQ-5D [ Time Frame: 6 month ]
    Individual's general health related quality of life is measured with EQ-5D

  • EQ-5D [ Time Frame: 1 year ]
    Individual's general health related quality of life is measured with EQ-5D

  • EQ-5D [ Time Frame: 2 year ]
    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: December 2018
Primary Completion Date: April 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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246167


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

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Kjeld Soballe, Professor         
Sub-Investigator: Inger Mechelenburg, Dos         
Sub-Investigator: Kaj V Dossing, MD         
Estonia
Regionaalhaigla, PERH Recruiting
Tallinn, Estonia
Contact: Kristo Kask, PhD         
Finland
Jyväskylä Central Hospital Recruiting
Jyväskylä, Keski-Suomi, Finland, 40620
Contact: Juha Paloneva, MD PhD         
Sub-Investigator: Juha Paloneva, MD PhD         
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         
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Hans Berg, Docent         
Sub-Investigator: Hans Berg, Docent         
Sub-Investigator: Karl-Åke Jansson, Docent         
Uppsala University Hospital Recruiting
Uppsala, Sweden
Contact: Kenneth Jansson, PhD         
Sub-Investigator: Olof Wolf, MD         
Sub-Investigator: Peter Ström, MD         
Sponsors and Collaborators
Tampere University Hospital
Kuopio University Hospital
Jyväskylä Central Hospital
Karolinska University Hospital
University of Tampere
Academy of Finland
Uppsala University Hospital
Aarhus University Hospital
Regionaalhaigla, Tallinn
Tartu University Hospital
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: 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
  More Information

Publications:
Responsible Party: Antti Launonen, MD, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01246167     History of Changes
Other Study ID Numbers: R10127
First Submitted: November 15, 2010
First Posted: November 23, 2010
Last Update Posted: October 6, 2017
Last Verified: October 2017

Keywords provided by Antti Launonen, Tampere University Hospital:
Proximal humerus fracture
conservative
locking plate
Philos
Hemiprosthesis

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