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

• ClinicalTrials.gov Identifier: NCT01737060
• Recruitment Status: Completed
• First Posted: November 29, 2012
• Last Update Posted: October 4, 2022
• Sponsor: Oslo University Hospital
• Collaborators: Sykehuset Telemark; Sykehuset Asker og Baerum; Sykehuset Ostfold; Helse Forde; Sykehuset i Vestfold HF; Diakonhjemmet Hospital
• Information provided by (Responsible Party): Tore Fjalestad, Oslo University Hospital

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.

Condition or disease	Intervention/treatment	Phase
Proximal Humeral Fractures, AO/OTA (2007) Group B2 and C2	Device: Reverse total shoulder arthroplasty	Not Applicable

Detailed Description:

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

Angular stable plate means Proximal humerus plate (Philos)

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 1, 2013
• Actual Primary Completion Date: August 1, 2017
• Actual Study Completion Date: September 1, 2022

Arms and Interventions

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 Name: Delta Xtend shoulder proshesis
Experimental: Reverse Total Shoulder Artroplasty; Intervention group	Device: Reverse total shoulder arthroplasty; Other Name: Delta Xtend shoulder proshesis

Outcome Measures

Primary Outcome Measures :

1. Constant Shoulder Score [ Time Frame: 5 years ]
   Follow-up will be at 3-6-12 months and 2-5 years.

Secondary Outcome Measures :

1. Oxford Shoulder score [ Time Frame: 5 years ]
   Follow-up will be at 3-6-12 months and 2-5 years.

Other Outcome Measures:

1. 15D Quality of Life score [ Time Frame: 5 years ]
   Follow-up will be at 3-6-12 months and 2-5 years.
2. Health Economics [ Time Frame: 5 years ]
   Follow-up will be at 3-6-12 months and 2-5 years.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Norway

Oslo University Hospital

Oslo, Norway

Sponsors and Collaborators

Oslo University Hospital

Sykehuset Telemark

Sykehuset Asker og Baerum

Sykehuset Ostfold

Helse Forde

Sykehuset i Vestfold HF

Diakonhjemmet Hospital

More Information

Additional Information:

Trial website for patients, their relatives and health workers 

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Tore Fjalestad, MD PhD Senior Consultant, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT01737060
• Other Study ID Numbers: RTSA s422
• First Posted: November 29, 2012
• Last Update Posted: October 4, 2022
• Last Verified: October 2022

Keywords provided by Tore Fjalestad, Oslo University Hospital:

Reversed prosthesis, Philos, Severe displaced

Additional relevant MeSH terms:

Fractures, Bone; Humeral Fractures; Shoulder Fractures; Wounds and Injuries; Arm Injuries; Shoulder Injuries