NL-OMON41420
Completed
Not Applicable
Primary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly - A Multicenter Randomized trial - ProCon trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 65
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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