A hinged external fixator for complex elbow dislocations: A prospective cohort study

Completed

• Conditions: 10023213; Complex elbow dislocation; elbow dislocation

• Registration Number: NL-OMON36547
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients meeting the following inclusion criteria are eligible for enrolment:
1. Men or women aged 18 years and older (with no upper age limit)
2. Patient with a complex elbow dislocation (i.e., dislocation of the elbow joint, combined with at least a fracture of the radial head, coronoid process, or olecranon)
3. Patient was treated with a hinged external fixator after ORIF and/or arthroplasty due to persistent instability
4. Provision of informed consent by patient

Exclusion Criteria

If any of the following criteria applies, patients will be excluded:
1. Patients with distal intra-articular humeral fractures
2. Patients with additional traumatic injuries of the affected upper limb
3. Patients who underwent repair of the collateral ligaments
4. Patients with an impaired elbow function (i.e., stiff or painful elbow or neurological disorder of the upper limb) prior to the injury
5. Retained hardware around the affected elbow
6. Likely problems, in the judgment of the investigators, with maintaining follow-up (e.g., patients with no fixed address will be excluded)
7. Insufficient comprehension of the Dutch language to understand the rehabilitation program and other treatment information in the judgment of the attending physician
Exclusion of a patient because of enrolment in another ongoing drug or surgical intervention trial will be left to the discretion of the attending surgeon, on a case-by-case basis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) score</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Mayo elbow performance index (MEPI)<br /><br>Oxford Elbow Score<br /><br>Pain level at both sides (VAS)<br /><br>Range of motion at both sides<br /><br>Radiographic healing of the fractures<br /><br>Rate of secondary interventions<br /><br>Rate of complications<br /><br>Health-related quality of life (Short Form-36; SF-36)</p><br>