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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01737060
Recruitment Status : Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : August 22, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Proximal Humeral Fractures, AO Group B2 and C2 Device: Reverse total shoulder arthroplasty

Detailed Description:
RTSA equals Delta Xtend reversed total shoulder prosthesis. Angular stable plate means Proximal humerus plate (Philos)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Actual Study Start Date : January 1, 2013
Primary Completion Date : June 1, 2017
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Angular stable plate Philos
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


Outcome Measures

Primary Outcome Measures :
  1. Constant Shoulder Score [ Time Frame: 5 years ]
    Follow-up will be at 3-6-12 months and 2-5 years.


Secondary Outcome Measures :
  1. Oxford Shoulder score [ Time Frame: 5 years ]
    Follow-up will be at 3-6-12 months and 2-5 years.


Other Outcome Measures:
  1. 15D Quality of Life score [ Time Frame: 5 years ]
    Follow-up will be at 3-6-12 months and 2-5 years.

  2. Health Economics [ Time Frame: 5 years ]
    Follow-up will be at 3-6-12 months and 2-5 years.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01737060


Locations
Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Sykehuset Telemark
Sykehuset Asker og Baerum
Sykehuset Ostfold
Helse Førde
Sykehuset i Vestfold HF
Diakonhjemmet Hospital
More Information

Additional Information:
Publications:
Responsible Party: Tore Fjalestad, MD PhD Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01737060     History of Changes
Other Study ID Numbers: RTSA s422
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Tore Fjalestad, Oslo University Hospital:
Reversed prosthesis, Philos, Severe displaced

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