NCT01737060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

4.6 years

First QC Date

November 20, 2012

Last Update Submit

October 1, 2022

Conditions

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

Keywords

Reversed prosthesis, Philos, Severe displaced

Outcome Measures

Primary Outcomes (1)

  • Constant Shoulder Score

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

    5 years

Secondary Outcomes (1)

  • Oxford Shoulder score

    5 years

Other Outcomes (2)

  • 15D Quality of Life score

    5 years

  • Health Economics

    5 years

Study Arms (2)

Angular stable plate Philos

ACTIVE COMPARATOR

Open Reduction and Osteofixation with Philos plate and TiCron cerclages

Device: Reverse total shoulder arthroplasty

Reverse Total Shoulder Artroplasty

EXPERIMENTAL

Intervention group

Device: Reverse total shoulder arthroplasty

Interventions

Reverse total shoulder arthroplastyDEVICE
Also known as: Delta Xtend shoulder proshesis
Angular stable plate PhilosReverse Total Shoulder Artroplasty

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (4)

  • 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.

    PMID: 25261913RESULT

  • 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.

    PMID: 31977825RESULT

  • 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.

    PMID: 35727196DERIVED

  • 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.

    PMID: 35109905DERIVED

Related Links

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD Senior Consultant

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 29, 2012

Study Start

January 1, 2013

Primary Completion

August 1, 2017

Study Completion

September 1, 2022

Last Updated

October 4, 2022

Record last verified: 2022-10

Locations

NO(1)