Comminutive proximal humeral fractures
Conditions
Interventions
One group will receive a hemiarthroplasty (Affinis® Fracture shoulder
endoprosthesis (Mathys AG Bettlach)).
Critical aspects of the surgical procedure will be standardized. After surgery,
patients a
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients meeting the following inclusion criteria are eligible for enrolment: 1. Adult men or women aged 65 years and older (with no upper age limit) 2. Fracture of the humeral head 3. Selected three-part (Hertel classification type 9, 10, 11), selected four-part (Hertel type 12), anatomical neck (Hertel type 2), or split-head fractures of the humeral head in the judgement of the attending surgeon. All fractures should be classified according to the binary description system, based on 3D CT reconstructions 4. Operative treatment within 21 days of presenting to the emergency department (if randomized for HA) 5. Provision of informed consent by patient 6. Assurance that the surgeon who will perform HA has attended the pre-trial HA course.
Exclusion criteria
Exclusion criteria: If any of the following criteria applies, patients will be excluded: 1. Polytraumatized patients 2. Patients with an additional traumatic injury of the affected arm 3. Patients with pathological, recurrent or open fractures 4. Patients with an impaired shoulder function (i.e., stiff or painful shoulder, neurologic disorder of the upper limb, or diagnosed rotator cuff impairment) prior to the injury 5. Retained hardware around the affected humerus 6. Patients with a disorder of bone metabolism other than osteoporosis (i.e., Paget*s disease, renal osteodystrophy, osteomalacia) 7. Moderate or severe cognitively impaired patients (i.e., Mini-Mental Status Examination (MMSE) Six Item Screener with 3 or more errors) 8. Likely problems, in the judgment of the investigators, with maintaining follow-up (e.g., patients with no fixed address will be excluded) 9. Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information in the judgment of the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Constant score | — |
Secondary
| Measure | Time frame |
|---|---|
| DASH score, including optional module for sports/music performance Pain level at both sides (VAS) Secondary intervention Radiographic healing Mortality Complication rates in HA group: infection, neurovascular injury, malpositioning of the prosthesis, asceptic loosening of the prosthesis, dislocation of the tuberculi Complication rates in control group: malunion, nonunion, secondary dislocation, symptomatic avascular necrosis (AVN) of the humeral head SF-36 EQ-5D Costs and cost-effectiveness | — |
Countries
Netherlands
Outcome results
None listed