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NCT01737060: DELPHI

Displaced Proximal Humeral Fractures: Delta Prothesis or Philos Plate?

Completed NA Last updated 4 October 2022
What this trial tests

NA trial testing Reverse total shoulder arthroplasty in Proximal Humeral Fractures, AO/OTA (2007) Group B2 and C2 in 124 participants. Completed in 1 September 2022.

Timeline
1 January 2013
Primary endpoint
1 August 2017
1 September 2022

Quick facts

Lead sponsorOslo University Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment124
Start date1 January 2013
Primary completion1 August 2017
Estimated completion1 September 2022
Sites1 location across Norway

Drugs / interventions tested

Conditions studied

Sponsor

Oslo University Hospital

Who can join

Adults 65 to 85, any sex, with Proximal Humeral Fractures, AO/OTA (2007) Group B2 and C2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Reverse Shoulder Arthroplasty Is Superior to Plate Fixation at 2 Years for Displaced Proximal Humeral Fractures in the Elderly: A Multicenter Randomized Controlled Trial.
    Fraser AN, Bjørdal J, Wagle TM, Karlberg AC, et al · · 2020 · cited 136× · PMID 31977825 · DOI 10.2106/jbjs.19.01071
  2. Clinical investigation for displaced proximal humeral fractures in the elderly: a randomized study of two surgical treatments: reverse total prosthetic replacement versus angular stable plate Philos (The DELPHI-trial).
    Fjalestad T, Iversen P, Hole MØ, Smedsrud M, et al · · 2014 · cited 20× · PMID 25261913 · DOI 10.1186/1471-2474-15-323
  3. Pegs not superior to screws for fixation of fractures of the proximal humerus.
    Bønes I, Karlberg AC, Liljeholm M, Fraser AN, et al · · 2022 · cited 4× · PMID 35109905 · DOI 10.1186/s13018-022-02947-3
  4. Assessment of therapeutic clinical trials for proximal humeral fractures.
    Koa J, Fares MY, Daher M, Abboud JA. · · 2024 · cited 2× · PMID 38556914 · DOI 10.5397/cise.2023.00521
  5. External validity in a multicenter randomized clinical trial of proximal humeral fractures: the DelPhi trial.
    Tallay E, Lindberg SK, Lee-Ødegård S, Bjordal J, et al · · 2022 · cited 2× · PMID 33880653 · DOI 10.1007/s00590-021-02982-6

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