Fri., 10/14/11 Tibia, Paper #53, 11:43 am OTA-2011
A Comparison of Efficacy and Resource Utilization Between Acute BMP-2 and Standard Treatment in Type III Tibia Fractures: A Multicenter Prospective, Randomized Controlled Trial
OTA Study Group: Michael J. Bosse, MD1; Robert D. Zura, MD2; Andrew N. Pollak, MD3;
David A. Volgas, MD4; William T. Obremskey, MD5; David P. Barei, MD6; Rachel Seymour, PhD1;
1Carolinas Medical Center is in Charlotte, North Carolina, USA;
2Duke University is in Durham, North Carolina, USA;
3Shock Trauma/University of Maryland is in Baltimore, Maryland, USA;
4University of Alabama at Birmingham is in Colombia, Missouri, USA;
5Vanderbilt University Medical Center is in Nashville, Tennessee, USA;
6Harborview Medical Center is in Seattle, Washington, USA
Purpose: The use of expensive therapies in the treatment of trauma patients is often difficult to justify without efficacy and resource utilization data. The acute use of BMP-2 in open tibia fractures is restricted in many centers related to its cost. We hypothesized that a reduction in later hospital system resource utilization related to the treatment of tibia fracture-site complications might justify BMP-2 therapy in severe open tibia fractures.
Methods: Six trauma centers participated in a multicenter prospective, randomized controlled trial. Type III open tibial diaphyseal fractures with less than 4 cm bone loss were randomized to standard treatment (SOC) or early/acute BMP-2 collagen sponge treatment (no allo/autograft or filler materials). All fractures were treated with reamed locked intramedullary nails. Patients were followed until hospital readmission for a complication, fracture union, or 1 year. Cohorts were compared based on post–initial hospital discharge resource utilization related to the tibia fracture site. The number of readmissions, related surgeries, and additional hospital days were used as measures of resource utilization.
Results: 65 patients were randomized. Three patients randomized to BMP were crossovers to the SOC cohort (2 were lost to follow-up). In total, 11 BMP-2 and 7 SOC patients were lost to follow-up. The difference in loss to follow-up was not significant (P = 0.13). 47 patients (19 BMP-2 and 28 SOC) were included in the analysis. 88% were male (average age, 39 years) and 83% had type III B injuries. 74% of BMP and 75% of SOC had OTA 42B/42C fractures. There were no significant differences between the cohorts on demographics or other injury characteristics. 58% (11/19) of BMP-2 patients versus 25% (7/28) of SOC patients achieved primary union (no fracture site readmission and union by 1 year) (P = 0.023). There was no difference in deep infection (11% in both) or amputation rates (BMP 5% vs 7%). By 1 year, only 74% of the BMP-2 and 54% of the SOC patients were united (P = 0.16). We calculated that a BMP-2 patient averaged 0.5 fewer additional surgeries and 1.7 fewer additional hospital days per patient than those entered into the SOC cohort.
Conclusions: BMP-2 patients had significantly higher primary union rates and lower post–primary hospitalization resource utilization rates. Despite the increased cost associated with the use of BMP-2 during the initial admission, overall treatment costs are decreased related to fewer readmissions and revision surgeries. Early BMP -2 use in type III tibia fractures might be considered as a “loss avoidance” strategy.
Alphabetical Disclosure Listing (628K PDF)
• The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an “off label” use). ◆FDA information not available at time of printing. Δ OTA Grant.