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

Shoulder Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02944058
• Other study ID #: 2016/626
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: October 25, 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 79
• Est. completion date: October 25, 2025
• Est. primary completion date: October 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients > 18 years

2. Severe displacement, defined as malposition of at least 45° of angular deviation in valgus or 30° 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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Humeral Fractures, Proximal
• Shoulder Fractures

Intervention

Procedure:
• Multiloc nail
Intervention is surgery with Multiloc nail
• Philos plate
Intervention is surgery with Philos plate

Locations

Country	Name	City	State
Norway	Akershus University hospital	Lørenskog

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Radiological complications	Plate cutout, Nail migration, screw cutout, Reduction of Head shaft angle (HSA)/ Varus subsidence,	5 years
Secondary	Complications	Infection, Avascular necrosis, thrombosis, nerve compression or damage, Pseudoarthrosis	5 years
Secondary	Health economy	Registration of visits to doctor, physiotherapist, sick leave, re-operations	5 years