Displaced Proximal Humeral Fractures: Delta Prothesis or Philos Plate? (DELPHI)

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

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.

Study Overview

• Status: Completed
• Conditions: Proximal Humeral Fractures, AO/OTA (2007) Group B2 and C2
• Intervention / Treatment: Device: Reverse total shoulder arthroplasty

Detailed Description

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

Angular stable plate means Proximal humerus plate (Philos)

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Angular stable plate Philos; Open Reduction and Osteofixation with Philos plate and TiCron cerclages	Device: Reverse total shoulder arthroplasty; Other Names: Delta Xtend shoulder proshesis
Experimental: Reverse Total Shoulder Artroplasty; Intervention group	Device: Reverse total shoulder arthroplasty; Other Names: Delta Xtend shoulder proshesis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Diakonhjemmet Hospital; Sykehuset Telemark; Helse Forde; Sykehuset Ostfold; Sykehuset i Vestfold HF; Sykehuset Asker og Baerum

Publications and helpful links

General Publications

• Bones I, Karlberg AC, Liljeholm M, Fraser AN, Madsen JE, Fjalestad T. Pegs not superior to screws for fixation of fractures of the proximal humerus. J Orthop Surg Res. 2022 Feb 2;17(1):66. doi: 10.1186/s13018-022-02947-3.
• Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
• Fjalestad T, Iversen P, Hole MO, Smedsrud M, Madsen JE. 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). BMC Musculoskelet Disord. 2014 Sep 28;15:323. doi: 10.1186/1471-2474-15-323.
• Fraser AN, Bjordal J, Wagle TM, Karlberg AC, Lien OA, Eilertsen L, Mader K, Apold H, Larsen LB, Madsen JE, Fjalestad T. Reverse Shoulder Arthroplasty Is Superior to Plate Fixation at 2 Years for Displaced Proximal Humeral Fractures in the Elderly: A Multicenter Randomized Controlled Trial. J Bone Joint Surg Am. 2020 Mar 18;102(6):477-485. doi: 10.2106/JBJS.19.01071. Erratum In: J Bone Joint Surg Am. 2020 Jun 17;102(12):e63.

Helpful Links

• Trial website for patients, their relatives and health workers

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (Estimate): November 29, 2012

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 1, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Reversed prosthesis, Philos, Severe displaced
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: RTSA s422