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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Reverse total shoulder arthroplasty

About this trial

This is an interventional treatment trial for Proximal Humeral Fractures, AO/OTA (2007) Group B2 and C2 focused on measuring Reversed prosthesis, Philos, Severe displaced

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept 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.

Sites / Locations

Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Angular stable plate Philos

Reverse Total Shoulder Artroplasty

Arm Description

Open Reduction and Osteofixation with Philos plate and TiCron cerclages

Intervention group

Outcomes

Primary Outcome Measures

Constant Shoulder Score

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

Secondary Outcome Measures

Oxford Shoulder score

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

Full Information

NCT ID

NCT01737060

First Posted

November 20, 2012

Last Updated

October 1, 2022

Sponsor

Oslo University Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01737060

Brief Title

Displaced Proximal Humeral Fractures: Delta Prothesis or Philos Plate?

Acronym

DELPHI

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2013 (Actual)

Primary Completion Date

August 1, 2017 (Actual)

Study Completion Date

September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Reversed prosthesis, Philos, Severe displaced

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Angular stable plate Philos

Arm Type

Active Comparator

Arm Description

Open Reduction and Osteofixation with Philos plate and TiCron cerclages

Arm Title

Reverse Total Shoulder Artroplasty

Arm Type

Experimental

Arm Description

Intervention group

Intervention Type

Device

Intervention Name(s)

Reverse total shoulder arthroplasty

Other Intervention Name(s)

Delta Xtend shoulder proshesis

Primary Outcome Measure Information:

Title

Constant Shoulder Score

Description

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Oxford Shoulder score

Description

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

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

15D Quality of Life score

Description

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

Time Frame

5 years

Title

Health Economics

Description

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

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Oslo University Hospital

City

Oslo

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

25261913

Citation

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.

Results Reference

result

PubMed Identifier

31977825

Citation

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.

Results Reference

result

PubMed Identifier

35727196

Citation

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.

Results Reference

derived

PubMed Identifier

35109905

Citation

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.

Results Reference

derived

Links:

URL

https://oslo-universitetssykehus.no/avdelinger/ortopedisk-klinikk/ortopedisk-avdeling-ulleval/seksjon-for-ortopedisk-traumatologi-ulleval/brudd-i-ovre-del-av-overarmsbeinet-proksimale-humerus-delphistudien

Description

Trial website for patients, their relatives and health workers

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Displaced Proximal Humeral Fractures: Delta Prothesis or Philos Plate?

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