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Completed

NCT Number: NCT01737060

Displaced Proximal Humeral Fractures: Delta Prothesis or Philos Plate?

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.

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, Norway

About this study

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

Angular stable plate means Proximal humerus plate (Philos)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reverse total shoulder arthroplasty

Device

Other names: Delta Xtend shoulder proshesis

Primary outcomes

  1. Constant Shoulder Score

    Time frame: 5 years

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

Secondary outcomes

  1. Oxford Shoulder score

    Time frame: 5 years

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

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

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

Registry information

Official study 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

Acronym: DELPHI

Important dates

Study start
2013
Primary completion
2017
Study completion
2022
First posted
Nov 29, 2012
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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