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

Sponsor
Oslo University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01737060
Collaborator
Sykehuset Telemark (Other), Sykehuset Asker og Baerum (Other), Sykehuset Ostfold (Other), Helse Forde (Other), Sykehuset i Vestfold HF (Other), Diakonhjemmet Hospital (Other)
125
Enrollment
1
Location
2
Arms
113
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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. Short name: The DelPhi trial.

Condition or Disease Intervention/Treatment Phase
  • Device: Reverse total shoulder arthroplasty
 N/A

Detailed Description

Reversed total shoulder artroplasty (RTSA) equals Delta Xtend reversed total shoulder prosthesis.

Angular stable plate means Proximal humerus plate (Philos)

Study Design

Study Type:
Interventional
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 :
Jan 1, 2013
Actual Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Jun 1, 2022

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 Names:
  • Delta Xtend shoulder proshesis

    		•
    Experimental: Reverse Total Shoulder Artroplasty

    Intervention group

    Device: Reverse total shoulder arthroplasty
    Other Names:
  • Delta Xtend shoulder proshesis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Constant Shoulder Score [5 years]

      Follow-up will be at 3-6-12 months and 2-5 years.

    Secondary Outcome Measures

    1. Oxford Shoulder score [5 years]

      Follow-up will be at 3-6-12 months and 2-5 years.

    Other Outcome Measures

    1. 15D Quality of Life score [5 years]

      Follow-up will be at 3-6-12 months and 2-5 years.

    2. Health Economics [5 years]

      Follow-up will be at 3-6-12 months and 2-5 years.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Oslo University Hospital Oslo Norway

    Sponsors and Collaborators

    • Oslo University Hospital
    • Sykehuset Telemark
    • Sykehuset Asker og Baerum
    • Sykehuset Ostfold
    • Helse Forde
    • Sykehuset i Vestfold HF
    • Diakonhjemmet Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Tore Fjalestad, MD PhD Senior Consultant, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT01737060
    Other Study ID Numbers:
    • RTSA s422
    First Posted:
    Nov 29, 2012
    Last Update Posted:
    Apr 26, 2022
    Last Verified:
    Apr 1, 2022
    Keywords provided by Tore Fjalestad, MD PhD Senior Consultant, Oslo University Hospital
    Reversed prosthesis, Philos, Severe displaced
    Additional relevant MeSH terms:
    Fractures, Bone
    Humeral Fractures
    Shoulder Fractures

    Study Results

    No Results Posted as of Apr 26, 2022