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

Oslo University Hospital1 site in 1 country124 target enrollmentJanuary 1, 2013

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Proximal Humeral Fractures, AO/OTA (2007) Group B2 and C2
Sponsor: Oslo University Hospital
Enrollment: 124
Locations: 1
Primary Endpoint: Constant Shoulder Score
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

January 1, 2013

End Date

September 1, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oslo University Hospital

Responsible Party

Principal Investigator

Tore Fjalestad

MD PhD Senior Consultant

Oslo University Hospital

Eligibility Criteria

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.