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Functional treatment versus plaster for simple elbow dislocations: a randomized trial

Functional treatment versus plaster for simple elbow dislocations: a randomized trial - FuncSiE trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36458
Enrollment
100
Registered
2009-08-26
Start date
2009-08-28
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

elbow luxation simple elbow dislocation

Interventions

Functional treatment group: The affected arm will be put in a pressure bandage for three weeks. Early active movements within the limits of pain are allowed. Usually by the second day the patients a

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. Adult men or women aged 18 years and older (with no upper age limit) 2. A simple dislocation of the elbow (i.e., without associated fractures) that can be closed reduced 3. Provision of informed consent by patient.

Exclusion criteria

Exclusion criteria: If any of the following criteria applies, patients will be excluded: 1. Polytraumatized patients 2. Patients with complex, pathological, recurrent or open dislocations 3. Patients with additional traumatic injuries of the affected arm 4. Patients undergoing surgical repair of collateral ligaments of the dislocated elbow joint 5. Patients with an impaired elbow function (i.e., stiff or painful elbow or neurological disorder of the upper limb) prior to the injury 6. Retained hardware around the affected elbow 7. History of operations or fractures involving the elbow 8. Patients with rheumatoid arthritis 9. Likely problems, in the judgment of the attending physician or investigators, with maintaining follow-up (e.g., patients with no fixed address will be excluded) 10. Insufficient comprehension of the Dutch language to understand a 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
May Elbow Performance Index (MEPI) Oxford Elbow Score Pain level at both sides (VAS) Range of Motion of the elbow joint at both sides Rate of secondary interventions Rate of complication rates Health-related quality of life: SF-36 andEQ-5D Radiographic appearance of elbow joint (degenerative changes and ectopic ossifications) Costs Cost-effectiveness

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)