Displaced Proximal Humeral Fractures: Delta Prothesis or Philos Plate?

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01737060

Acronym

DELPHI

Enrollment

124

Registered

2012-11-29

Start date

2013-01-01

Completion date

2022-09-01

Last updated

2022-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Humeral Fractures, AO/OTA (2007) Group B2 and C2

Keywords

Reversed prosthesis, Philos, Severe displaced

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)

Interventions

DEVICEReverse total shoulder arthroplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Constant Shoulder Score	5 years	Follow-up will be at 3-6-12 months and 2-5 years.

Secondary

Measure	Time frame	Description
Oxford Shoulder score	5 years	Follow-up will be at 3-6-12 months and 2-5 years.

Other

Measure	Time frame	Description
15D Quality of Life score	5 years	Follow-up will be at 3-6-12 months and 2-5 years.
Health Economics	5 years	Follow-up will be at 3-6-12 months and 2-5 years.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026