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

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 immobilisation, surgical treatment of ruptured collateral ligaments,
functional treatment, or a combination thereof. When comparing functional
treatment versus plaster immobilisation 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,
favouring the patients treated conservatively. Furthermore, when two
observational studies were pooled comparing functional treatment with plaster
immobilisation, 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.

Primary objective
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 objectives
1. To examine the effect of a pressure bandage versus plaster treatment on the
degree of sports/music performance (Quick-DASH optional module) in adult
patients who sustained a simple elbow dislocation
2. To examine the effect of a pressure bandage versus plaster treatment on the
Mayo elbow performance index (MEPI) in adult patients who sustained a simple
elbow dislocation
3. To examine the effect of a pressure bandage versus plaster treatment on the
Oxford score in adult patients who sustained a simple elbow dislocation
4. To examine the effect of a pressure bandage versus plaster treatment on the
level of pain (Visual Analog Scale, VAS) in adult patients who sustained a
simple elbow dislocation
5. To examine the effect of a pressure bandage versus plaster treatment on the
range of motion (extension, flexion, pro- and supination) of the elbow joint in
adult patients who sustained a simple elbow dislocation
6. To examine the effect of a pressure bandage versus plaster treatment on the
rate of secondary interventions and complications (redislocations, instability
and heterotopic ossifications) in adult patients who sustained a simple elbow
dislocation
7. To examine the effect of a pressure bandage versus plaster treatment on
health-related quality of life (Short Form-36 (SF-36) and EuroQol-5D (EQ-5D))
in adult patients who sustained a simple elbow dislocation
8. To examine the costs and cost-effectiveness of using a pressure bandage
versus plaster treatment in adult patients who sustained a simple elbow
dislocation
9. To examine the reliability and validity of the Dutch version of the Oxford
elbow score by comparing the scores with the scores of the Quick-DASH and SF-36
in adult patients treated for elbow dislocations

Multi-center randomized clinical trial

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 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.

Both interventions are Standard of Care treatment modalities.

The clinic follow-up visits at t=1, 3 and 6 weeks, and 3, 6 and 12 months are
part of Standard of Care. The same holds true for the X-rays for the diagnosis,
after reposition and after 1 week and 1 year.

Patients are asked to complete a set of questionnaires at the clinic FU visits
mentioned. There are no risks involved in this.