Functional treatment versus plaster for Simple Elbow dislocations (FuncSiE): a randomized trial.

BACKGROUND:

The elbow joint is the second most commonly dislocated joint in adults. The annual incidence of elbow dislocations in children and adults is 6.1 per 100.000. Elbow dislocations are classified as simple or complex types. Complex dislocations are associated with fractures of the distal humerus, radial head, ulna, or coronoid process. Simple dislocations are dislocations without fractures. Different treatment modalities can be appliced after reposition, including plaster immobilization, surgical treatment of ruptured collateral ligaments, functional treatment, or a combination thereof. When comparing functional treatment versus plaster immobilization only one RCT was retrieved. Extension and flexion of the elbow did not differ between the groups after one year. Nevertheless, a difference in elbow extension was observed at three months, favoring the patients treated conservatively. Furthermore,when two observational studies were pooled comparing functional treatment with plaster immobilization, functional treatment showed a statistically significant better result for pain and range of motion. Although results after functional treatment seem promising, a RCT is needed to further test superiority of either treatment.



AIM:

The primary objective of this RCT is to compare the Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire scores, a questionnaire reflecting functional outcome and pain after a pressure bandage (e.g. Tubigrip®) versus plaster treatment in adult patients (age 18 years or older), who sustained a simple elbow dislocation. Secondary aims are to assess effects on functional outcome, pain, range of motion, rates of complication and secondary interventions, and quality of life in these patients. The costs and cost-effectiveness of both interventions will be determined.




STUDY DESIGN:

Multi-center randomized clinical trial.




POPULATION:

Patients aged 18 years or older with a simple elbow dislocation that can be closed reduced.



INTERVENTIONS:

Functional treatment group: The affected arm will be put in a pressure bandage for up to three weeks. Early active movements within the limits of pain are allowed. Usually by the second day the patients are instructed two exercises by a physical therapist, which are gradually expanded if tolerated.Plaster group: The affected arm will be put in plaster of Paris for three weeks. At three weeks after dislocation the plaster will be removed and full mobilization (flexion, extension, pro and supination) will be initiated by practicing under supervision of a physical therapist. Physical therapy sessions will be held at regular intervals, preferably 2 times a week during 12 weeks.




ENDPOINTS:

Primary outcome (Quick-DASH) and secondary outcomes (MEPI, Oxford Elbow Score, pain, ROM, secondary intervention rates, complication rates, SF-36, and EQ-5D) will be compared at baseline, at 1, 3 and 6 weeks, and at 3, 6, and 12 months after start of treatment, using both univariate and multivariable analyses. Costs for (in)formal healthcare consumption will be determined for both interventions, Cost-effectiveness will be expressed as cost per quality of life year (QALY) gained.

Functional treatment of a simple elbow dislocation with a pressure bandage (e.g. Tubigrip®) results in improved Quick-DASH scores (reflecting better functional outcome with less pain) compared with plaster. Improved Quick-DASH scores are expected to be noticeable from six weeks after treatment initiation onwards, reflecting a quicker functional recovery for the functional treatment group.

Baseline, 1 week, 3 weeks, 6 weeks, 3 months, 6 months, 12 months.

1. Functional treatment;

2. Plaster treatment.