NCT00853489

rhBMP-2 Versus Autograft in Critical Size Tibial Defects

RhBMP-2 vs. Autograft for Critical Size Tibial Defects: A Multicenter Randomized Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: St. Louis University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of our study is to evaluate the use of recombinant human bone morphogenetic protein 2 (RhBMP-2) as compared to standard ICBG in the treatment of severe open tibia fractures with a critical size bone defect (at least one centimeter in length compromising at least 50% of the circumference of the bone).

Detailed description

Open tibia fractures have a 15% or higher rate of not healing. Those fractures which do not heal are typically treated with bone from the hip (iliac crest autograft; or ICBG). The use of ICBG bone with the treatment of delayed unions/non-unions with critical defect, although successful, has its drawbacks. The bone graft sources are limited and the procedure is associated with additional operating room time plus a second incision with increased risk of infection, post operative pain and increased hospital stay. The purpose of this study is to determine if Rh-BMP2, a new bone graft substitute, is at least as effective as using bone from the hip (autograft) to help promote healing of open, tibia (shin bone) fractures. Research Questions: Primary: What is the relative effect of rhBMP-2 versus autogenous ICBG on rates of union in patients with critical size defects following tibial shaft fractures? Null hypothesis #1: rhBMP-2 has the same union rate when used in critical-sized defects as does ICBG. Secondary: What is the relative effect of rhBMP-2 versus autogenous ICBG on infection rates in patients with nonunion or critical size defects following tibial shaft fractures? Null hypothesis #2: The infection rate in open tibias with critical-sized defects treated with rhBMP-2 and autogenous ICBG are the same. What is the economic impact of the use of Rh-BMP 2 for tibial fractures with critical sized defects? Null hypothesis #3: There will be no difference in the economic cost of the treatment of critical sized defects using the RhBMP-2 versus iliac crest bone graft.

Conditions

• Tibial Fractures

Interventions

Type	Name	Description
DEVICE	recombinant bone morphogenetic protein 2	Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft
PROCEDURE	Autogenous iliac crest bone graft	Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice.

Timeline

• Start date: 2011-08-01
• Primary completion: 2017-02-17
• Completion: 2017-02-17
• First posted: 2009-03-02
• Last updated: 2018-10-25
• Results posted: 2018-03-13

Locations

13 sites across 1 country: United States