Session XII - Upper Extremity
A Multicenter Prospective Randomized Controlled Trial of Open Reduction and Internal Fixation versus Total Elbow Arthroplasty for Displaced Intra-articular Distal Humeral Fractures in Elderly Patients
Purpose: We conducted a prospective randomized controlled trial to compare functional outcomes, complications, and reoperation rates in elderly patients with displaced intra-articular distal humerus fractures treated with open reduction and internal fixation (ORIF) or primary semiconstrained total elbow arthroplasty (TEA).
Methods: 42 patients were randomized by sealed envelope. Inclusion criteria were age >65 years, displaced intra-articular fractures of the distal humerus (OTA Type 13C), and closed or Gustilo grade I open fractures treated within 12 hours of injury. Both ORIF and TEA were performed following a standardized protocol. Mayo Elbow Performance Score (MEPS) and Disabilities of the Arm, Shoulder and Hand (DASH) scores were collected at 6 weeks, 3 months, 6 months, 12 months, and 2 years. Complication type, duration, management, and treatment requiring reoperation were recorded. An intention-to-treat and an on-treatment analysis were conducted to address patients randomized to ORIF but converted to TEA intraoperatively.
Results: 21 patients were randomized to each treatment group.
Two patients died prior to follow-up and were excluded from the study. Five
patients randomized to ORIF were converted to TEA intraoperatively because
of extensive comminution and inability to obtain fixation stable enough
to allow early range of motion. This resulted in 15 patients (3 male, 12
female) with an average age of 77 years in the ORIF group and 25 patients
(2 male, 23 female) with an average age of 78 in the TEA group. Baseline
demographics for mechanism, classification, comorbidities, fracture type,
activity level and ipsilateral injuries were similar between the two groups.
MEPS was significantly improved at 3 months (82 vs. 65, P = 0.01),
6 months (86 vs. 66, P = 0.003), 12 months (87 vs. 72, P =
0.03), and 2 years (86 vs. 73, P = 0.04) in patients with TEA compared
with ORIF.
DASH scores showed a significant improvement for TEA compared with ORIF
between 6 weeks (43 vs. 77, P = 0.02) and 6 months (31 vs. 50, P
= 0.01) but not at 12 months (32 vs. 47, P = 0.1) and 2 years (34
vs. 38, P = 0.6). The mean flexion-extension arc was 107° (range,
42-145) for the TEA group and 95° (range, 30-140) for the ORIF group
(P = 0.19). Reoperation rates for TEA (3/25) and ORIF (4/15) were
not statistically different (P =0.2).
Conclusion: TEA for the treatment of comminuted intra-articular distal humeral fractures provides improved functional outcome compared with ORIF based on both objective elbow performance scores and patient self-rated upper extremity disability and symptoms. TEA may result in decreased reoperation rates considering 25% of OTA Type 13C fractures were not amenable to internal fixation. Elderly patients have an increased baseline DASH score and appear to accommodate to objective limitations in function with time.
This study was supported by grants from the OTA and Zimmer Inc.