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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 : September 22, 2020
Sponsor:
Collaborators:
Sykehuset Telemark
Sykehuset Asker og Baerum
Sykehuset Ostfold
Helse Forde
Sykehuset i Vestfold HF
Diakonhjemmet Hospital
Information provided by (Responsible Party):
Tore Fjalestad, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE November 20, 2012
First Posted Date  ICMJE November 29, 2012
Last Update Posted Date September 22, 2020
Actual Study Start Date  ICMJE January 1, 2013
Actual Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2012)
Constant Shoulder Score [ Time Frame: 5 years ]
Follow-up will be at 3-6-12 months and 2-5 years.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2012)
Oxford Shoulder score [ Time Frame: 5 years ]
Follow-up will be at 3-6-12 months and 2-5 years.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 26, 2012)
  • 15D Quality of Life score [ Time Frame: 5 years ]
    Follow-up will be at 3-6-12 months and 2-5 years.
  • Health Economics [ Time Frame: 5 years ]
    Follow-up will be at 3-6-12 months and 2-5 years.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Displaced Proximal Humeral Fractures: Delta Prothesis or Philos Plate?
Official Title  ICMJE 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
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.
Detailed Description

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

Angular stable plate means Proximal humerus plate (Philos)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Proximal Humeral Fractures, AO/OTA (2007) Group B2 and C2
Intervention  ICMJE Device: Reverse total shoulder arthroplasty
Other Name: Delta Xtend shoulder proshesis
Study Arms  ICMJE
  • Active Comparator: Angular stable plate Philos
    Open Reduction and Osteofixation with Philos plate and TiCron cerclages
    Intervention: Device: Reverse total shoulder arthroplasty
  • Experimental: Reverse Total Shoulder Artroplasty
    Intervention group
    Intervention: Device: Reverse total shoulder arthroplasty
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 19, 2017)
125
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2012)
120
Estimated Study Completion Date  ICMJE June 1, 2022
Actual Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01737060
Other Study ID Numbers  ICMJE RTSA s422
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tore Fjalestad, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE
  • Sykehuset Telemark
  • Sykehuset Asker og Baerum
  • Sykehuset Ostfold
  • Helse Forde
  • Sykehuset i Vestfold HF
  • Diakonhjemmet Hospital
Investigators  ICMJE Not Provided
PRS Account Oslo University Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP