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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Shoulder Fractures; Humeral Fractures, Proximal
• Intervention / Treatment: Procedure: Philos plate; Procedure: Multiloc nail

Detailed Description

Randomized controlled trial (RCT) from Akershus University Hospital in Norway. Randomization between two implants. The investigators will use deltopectoral or deltoid split as surgical access. All patients will have calcar screws and cuff sutures. When lack of bone for example after decompressing valgus compressed fractures, a bone-substitute might be used in the surgeons preference. Follow up in outpatient clinic at 6, 12, 52 and 104 weeks, but also a 5 year follow up is planned. Postoperative radiographs of both shoulders and CT of operated shoulder will be taken.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Lørenskog, Norway, 1478
    • Akershus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients > 18 years
2. 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
3. The greater or lesser tubercles must be fractured in a 3 or 4-part fracture. The degree of displacement is not critical for inclusion.

Exclusion Criteria:

Exclusion criteria:

1. Fracture more than 3 weeks' old
2. Caput humeri just a thin shell or split
3. Ipsilateral damage that will influence the recovery and scoring systems
4. Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity.
5. Pathological fracture
6. Neurovascular injury
7. Open fracture
8. Noncompliance
9. Congenital anomaly
10. Ongoing infectious process around the incision site for plate osteosynthesis
11. Systemic disease that may influence healing processes or scoring systems (RA/MS)
12. Fracture dislocation
13. Substance abuse
14. Inability to read and understand Norwegian
15. Patients not residing in our catchment area
16. Patients with too small humerus diameter to use a nail
17. Patient not able to commit and understand written consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Philos plate; Intervention is surgery with Philos plate	Procedure: Philos plate; Intervention is surgery with Philos plate
Active Comparator: Multiloc nail; Intervention is surgery with Multiloc nail	Procedure: Multiloc nail; Intervention is surgery with Multiloc nail

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant score (questionnaire)	A questionnaire for the doctor or the physiotherapist to fill out, including registration of: Pain, Power, Range of motion and ADL (x/100, where 100 is best score)	5years
Radiological complications	Plate cutout, Nail migration, screw cutout, Reduction of Head shaft angle (HSA)/ Varus subsidence,	5 years
Complications	Infection, Avascular necrosis, thrombosis, nerve compression or damage, Pseudoarthrosis	5 years
Health economy	Registration of visits to doctor, physiotherapist, sick leave, re-operations	5 years

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Investigators: Study Director: Asbjorn AAroen, PhD MD, Akershus University Hospital, orthopedic unit

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Estimated): October 24, 2023
• Study Completion (Estimated): October 25, 2025

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 23, 2016
• First Posted (Estimated): October 25, 2016

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Multiloc; Philos; Locking plate; Straight nail; 3 and 4 part fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: 2016/626

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion