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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36547
Enrollment
30
Registered
2009-08-27
Start date
2009-08-28
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex elbow dislocation elbow dislocation

Interventions

Hinged external elbow fixator

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) score

Secondary

MeasureTime frame
Mayo elbow performance index (MEPI) Oxford Elbow Score Pain level at both sides (VAS) Range of motion at both sides Radiographic healing of the fractures Rate of secondary interventions Rate of complications Health-related quality of life (Short Form-36; SF-36)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)