Humeral Fractures, Proximal, Shoulder Fractures
Conditions
Keywords
Multiloc, Philos, Locking plate, Straight nail, Randomized controlled trial, 3 and 4 part fractures
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.
Interventions
PROCEDUREMultiloc nail
Intervention is surgery with Multiloc nail
PROCEDUREPhilos plate
Intervention is surgery with Philos plate
Sponsors
University Hospital, Akershus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score) | 5 years | Quick Dash (questionnaire) the first 6 weeks after surgery, then DASH score (questionnaire for patients to fill out) in follow ups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant score (questionnaire) | 5years | 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) |
| Radiological complications | 5 years | Plate cutout, Nail migration, screw cutout, Reduction of Head shaft angle (HSA)/ Varus subsidence, |
| Complications | 5 years | Infection, Avascular necrosis, thrombosis, nerve compression or damage, Pseudoarthrosis |
| Health economy | 5 years | Registration of visits to doctor, physiotherapist, sick leave, re-operations |
Countries
Norway
Outcome results
None listed