Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures

NCT02944058 | Unknown DMC

• 1 other identifier: 2016/626
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the project is to compare the management of 3 and 4 part proximal humerus fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail (Multiloc) in light of complications, radiological, economical, functional and clinical outcome.

Conditions

Shoulder Fractures; Humeral Fractures, Proximal

Keywords

Multiloc; Philos; Locking plate; Straight nail; Randomized controlled trial; 3 and 4 part fractures

Outcome Measures

Primary Outcomes (1)

• The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score)

  Quick Dash (questionnaire) the first 6 weeks after surgery, then DASH score (questionnaire for patients to fill out) in follow ups

  5 years

Secondary Outcomes (4)

• Constant score (questionnaire)

  5years

• Radiological complications

  5 years

• Complications

  5 years

• Health economy

  5 years

Study Arms (2)

Philos plate

ACTIVE COMPARATOR

Intervention is surgery with Philos plate

Procedure: Philos plate

Multiloc nail

ACTIVE COMPARATOR

Intervention is surgery with Multiloc nail

Procedure: Multiloc nail

Interventions

Multiloc nail PROCEDURE

Intervention is surgery with Multiloc nail

Multiloc nail

Philos plate PROCEDURE

Intervention is surgery with Philos plate

Philos plate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years
• Severe displacement, defined as malposition of at least 45⁰ of angular deviation in valgus or 30⁰ in varus in true frontal projection, regardless of whether the fracture is impacted or not. Fractures with more than 50% displacement of the head against the surgical neck

You may not qualify if:

• Fracture more than 3 weeks' old
• Caput humeri just a thin shell or split
• Ipsilateral damage that will influence the recovery and scoring systems
• Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity.
• Pathological fracture
• Neurovascular injury
• Open fracture
• Noncompliance
• Congenital anomaly
• Ongoing infectious process around the incision site for plate osteosynthesis
• Systemic disease that may influence healing processes or scoring systems (RA/MS)
• Fracture dislocation
• Substance abuse
• Inability to read and understand Norwegian
• Patients not residing in our catchment area

Sponsors & Collaborators

• University Hospital, Akershus: lead

Study Sites (1)

Akershus University hospital

Lørenskog, 1478, Norway

Location

Related Publications (1)

• 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: 35727196 DERIVED

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Study Officials

• Asbjorn AAroen, PhD MD

  Akershus University Hospital, orthopedic unit

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 25, 2016
• Study Start: October 1, 2016
• Primary Completion: October 24, 2023
• Study Completion: October 25, 2025
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)