OBJECTIVES: To compare 2 methods of initial immobilization of closed humeral shaft fractures-coaptation splinting followed by delayed functional bracing and immediate functional bracing-with respect to pain, satisfaction, and skin-related complications during the initial 10-day post-injury period.
DESIGN: Multicenter, randomized, two-arm, parallel clinical trial.
SETTING: One academic medical center with 2 Level 1 academic trauma centers and 1 tertiary care orthopaedic center.
PATIENT SELECTION CRITERIA: Patients with acute, closed humeral shaft fractures (AO/OTA 12A, 12B, 12C) were randomized to either initial coaptation splinting followed by delayed transition to Sarmiento bracing or immediate Sarmiento bracing.
OUTCOME MEASURES AND COMPARISONS: Pain intensity over time measured by a patient-reported Likert scale (numerical rating scale, 0-10) once daily at the same time during the first 10 days post-injury, skin-related complications (skin damage ranging from abrasion or blistering to full-thickness skin loss secondary to pressure from the splint or brace), analgesic consumption in morphine milligram equivalent (MME), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function scores, and patient satisfaction.
RESULTS: Fifty-eight patients were included in the analysis with a mean age of 48.8 ± 23.9 years (mean 50.5 years [range 18.4-92.2 years] in the coaptation splint group vs. mean 47.3 years [range 19.7-85.9 years] in the immediate Sarmiento brace group). Patients in the immediate Sarmiento bracing group reported significantly higher pain scores compared with coaptation splinting during the first 10 days postinjury (mean treatment effect = 0.97 points, 95% CI [0.26-1.69], P = 0.010; Figure 3). Cumulative opioid consumption over the 10-day period was similar between groups (median 20.0 MME for the coaptation splint group vs. 32.5 MME for the Sarmiento brace group, P = 0.308). PROMIS Physical Function scores were not significantly different between groups on postinjury day 7 (median 53.0 [IQR 44.5-68.5] for the splint group vs. 51.1 [IQR 45.0-60.5] for the brace group, P = 0.756). The rate of skin-related complications was higher in the Sarmiento brace group (33.3% vs. 7.1%, P = 0.022). Patient satisfaction scores at day 7 were not significantly different between groups (6.3 ± 2.7 for the coaptation splint group vs. 5.8 ± 3.1 for the Sarmiento brace group, P = 0.520).
CONCLUSIONS: Immediate Sarmiento bracing was associated with increased patient-reported pain (roughly 1 point on the 0-10 numeric rating scale) and higher skin complication rates during the initial 10-day period after injury compared with initial coaptation splinting for acute humeral shaft fractures, without demonstrable benefits in function, analgesic requirements, or patient satisfaction. These findings support the traditional approach of initial coaptation splinting followed by delayed transition to functional bracing once acute swelling subsides.
LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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