Primary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly - A Multicenter Randomized trial - ProCon trial

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 65 人开始时间: 待定最近更新: 2024年6月11日

试验速览

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•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.

•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.

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