FuncSiE Trial: EM of Elbow Dislocation Brings Faster Functional Recovery

Summary

The Functional Treatment Versus Plaster for Simple Elbow Dislocations trial [FuncSiE; NTR2025] found that early mobilization vs plaster immobilization resulted in earlier recovery of function and return to work, without any redislocations or persistent instability, as discussed in this article.

  • Shoulder & Elbow Conditions
  • Orthopaedic Procedures
  • Orthopaedics Clinical Trials
  • Orthopaedics
  • Shoulder & Elbow Conditions
  • Orthopaedic Procedures
  • Orthopaedics Clinical Trials

The Functional Treatment Versus Plaster for Simple Elbow Dislocations trial [FuncSiE; NTR2025] found that early mobilization (EM) vs plaster immobilization (PIM) resulted in earlier recovery of function and return to work, without any redislocations or persistent instability, according to Dennis den Hartog, MD, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands. EM was associated with slightly more pain at 1 week, but pain was similar in both groups at the other time points.

Elbow dislocations are rare (6/100 000 person-years) and always include injury of the ligaments. Complex elbow dislocations include a fracture, and surgical treatment is common. Treatment for simple elbow dislocations (SEDs) without a fracture is conservative and functional and strives to balance stability and prevent stiffness. Currently, there is little evidence on which to base treatment decisions for SED and there is no indication for standard surgical ligament repair [Taylor F et al. Cochrane Database Syst Rev. 2012]. Observational studies suggest the outcomes are similar with EM or PIM [De Haan J et al. Arch Orthop Trauma Surg. 2010.

The multicenter, randomized FuncSiE study was conducted to obtain prospective evidence with EM and PIM in patients with an SED. EM comprised a pressure bandage or tubigrip, early exercise within the limits of pain, and physical therapy (PT) commencing after 2 days, whereas PIM comprised a long arm cast for 3 weeks and PT commencing after cast removal. Assessments were made at weeks 1 and 3 and months 3, 6, and 12. The study was conducted from August 2009 to September 2012. Of the 100 patients randomized in the study, 48 in the EM group and 52 in the PIM group were available for analysis. In the EM and PIM groups, respectively, 46% and 39% were men, the average age was 43 years and 47 years, the injury was to the dominant arm in 50% and 42% of patients, and most had a low-energy trauma (94% and 92%).

The primary outcome of the Quick Disabilities of the Arm, Shoulder, and Hand score was significantly lower with EM (12) vs PIM (19) in the first 6 weeks (P < .05) but was similar (4) at 12 months in both groups.

The Oxford Elbow Score (OES) was similar in both groups at all assessments, whereas the OES functional domain score was significantly higher in the first 6 weeks in the EM vs PIM group (86% vs 73%) but was similar at 12 months (98% vs 97%). The Mayo Elbow Performance Index was about 95% in each group. Pain assessed with a visual analog scale score was significantly higher with EM vs PIM at 1 week (mean score 3.2 vs 2.2, respectively, P < .05), but thereafter it was similar (≤ 1) through 12 months in both groups.

The range of motion (ROM) assessed with the flexion/ extension (FE) score was 121° with EM and 102° with PIM (P < .05) at 6 weeks; at 12 months, it was similar at about 140°. The loss of ROM using the FE score was slightly less with EM vs PIM. The time to return to work and sports is detailed in Table 1. Patients returned to work 8 days earlier with EM vs PIM.

Table 1.

Time to Resumption of Work and Sports in the FuncSiE Study

The rate of complications was also similar with EM and PIM in the 40 and 43 patients analyzed, respectively. No redislocation or joint incongruency occurred in either group. Heterotopic ossification occurred in 55% and 65% of the EM and PIM groups, respectively, most of which was grade 2 (91% and 86%, respectively). Grade 3 ossification occurred in 11% of the PIM group vs none in the EM group.

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