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Displaced Proximal Humeral Fractures: Delta Prothesis or Philos Plate? (DELPHI)

This study is currently recruiting participants.
Verified February 2013 by Oslo University Hospital
Sponsor:
Collaborators:
Sykehuset Telemark
Sykehuset Asker og Baerum
Sykehuset Ostfold
Helse Førde
Sykehuset i Vestfold HF
Information provided by (Responsible Party):
Tore Fjalestad, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01737060
First received: November 20, 2012
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

To investigate the assumption that reversed shoulder prosthetic replacement will give a better functional outcome compared to open reduction and internal fixation with an angular stable plate in displaced proximal humeral fractures.


Condition Intervention
Proximal Humeral Fractures of Severe Displaced Types: AO / OTA Group B2 and C2 (Neer 3- and 4 Parts Displaced Fractures)
PMID:18277234
 Device: Reverse total shoulder arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Investigation for Fractures of the Proximal Humerus in Elderly Patients. A Randomized Study of Two Surgical Treatments: Reverse Total Shoulder Arthroplasty Versus Angular Stable Device Philos

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Constant Shoulder Score [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Follow-up will be at 3-6-12 months and 2-5 years.


Secondary Outcome Measures:
  • Oxford Shoulder score [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Follow-up will be at 3-6-12 months and 2-5 years.


Other Outcome Measures:
  • 15D Quality of Life score [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Follow-up will be at 3-6-12 months and 2-5 years.

  • Health Economics [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Follow-up will be at 3-6-12 months and 2-5 years.


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Angular stable plate fixation
Open Reduction and Osteofixation with Philos plate and TiCron cerclages
 Device: Reverse total shoulder arthroplasty
Other Name: Delta Xtend shoulder proshesis
Experimental: Reverse Total Shoulder Artroplasty
Intervention group
 Device: Reverse total shoulder arthroplasty
Other Name: Delta Xtend shoulder proshesis

Detailed Description:

RTSA means Delta Xtend prosthesis. Angular stable plate means Proximal humerus plate (Philos)

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient admitted in hospital with a displaced three- or four part proximal humerus fracture of OTA / AO group 11-B2 or 11-C2 (displaced fracture of extra-articular or articular, bifocal type). The subgroups -.1, -.2 and -.3 will be included for both B2 and C2 groups, provided severe displacement: This is defined as a mal-position of at least 45º of angular deviation in valgus or 30º in varus in true frontal projection, regardless of whether the fracture is impacted or not, or less than 50% contact between humeral head and the metaphyseal part of the shaft. The greater or lesser tubercle displaced at least 10 mm.

Exclusion Criteria:

Patient younger than 65 years or older than 85 years, previous history of injury or illness of the injured shoulder, injuries of other parts of the humerus or the contra-lateral upper extremity, alcohol- or drug abuse, dementia, neurological diseases, or severe cardiovascular or lung diseases that would contraindicate surgery. Patients have to understand the Norwegian language and be compliant to rehabilitation and follow-ups.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737060

Contacts
Contact: Tore Fjalestad, MD, PhD. 0047 22118080 tofjal@ous-hf.no
Contact: Jan Erik Madsen, MD, PhD, Professor 0047 22118080 j.e.madsen@klinmed.uio.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Tore Fjalestad, MD, PhD     0047 22118080     tofjal@ous-hf.no    
Principal Investigator: Tore Fjalestad, MD, PhD            
Sponsors and Collaborators
Oslo University Hospital
Sykehuset Telemark
Sykehuset Asker og Baerum
Sykehuset Ostfold
Helse Førde
Sykehuset i Vestfold HF
  More Information

Additional Information:
There will be a final link before recruiting starts in January 2013  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Tore Fjalestad, MD PhD Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01737060     History of Changes
Other Study ID Numbers: RTSA s422
Study First Received: November 20, 2012
Last Updated: February 21, 2013
Health Authority: National Committee for Medical and Health Research Ethics Norway:

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

ClinicalTrials.gov processed this record on May 21, 2013