Clinical trial NCT02944058: Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures
Official title: Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures. A RCT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Shoulder Fractures
Humeral Fractures, Proximal
Keywords: Multiloc
Philos
Locking plate
Straight nail
Randomized controlled trial
3 and 4 part fractures
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score)
timeFrame: 5 years
Secondary outcomes:
measure: Constant score (questionnaire)
timeFrame: 5years
measure: Radiological complications
timeFrame: 5 years
measure: Complications
timeFrame: 5 years
measure: Health economy
timeFrame: 5 years
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University hospital
Study officials:
affiliation: Akershus University Hospital, orthopedic unit
name: Asbjorn AAroen, PhD MD
role: STUDY_DIRECTOR
References:
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.