rhBMP-2 Versus Autograft in Critical Size Tibial Defects
|Tibial Fractures||Device: recombinant bone morphogenetic protein 2 Procedure: Autogenous iliac crest bone graft||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||RhBMP-2 vs. Autograft for Critical Size Tibial Defects: A Multicenter Randomized Trial|
- Fracture healing (union) at 12 months [ Time Frame: op2 weeks, 6 weeks, 12 weeks, 18 weeks, 6 months and 12 months post op ]
Union will be defined by meeting both of the following criteria:
- Radiographic union as defined by the RUST score, Radiographic evaluation will be assessed by blinded orthopaedic surgeons.
- Clinical union as defined by pain-free full weight bearing and lack of tenderness ,swelling and pain at the fracture site on palpation. Pain will be documented using the VAS at each visit. Swelling will be defined as the absence of skin wrinkling.
- Infection [ Time Frame: 2 weeks, 6 weeks, 12 weeks, 18 weeks, 6 months and 12 months post op. ]Infection will be assessed based on the CDC criteria for deep and superficial infection.
- Functional Status [ Time Frame: 2 weeks, 6 weeks, 12 weeks, 18 weeks, 6 months and 12 months post op ]Function will be measured using the SF12 and the Short Form Musculoskeletal Assessment (SMFA)
- Medical Cost [ Time Frame: 12 mos post op ]An economic evaluation will also be performed including the costs of iliac crest bone graft harvest and complications from the bone graft surgery and the cost of the Rh-BMP 2 and the biologic implant used in the treatment group.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2018|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Experimental: recombinant bone morphogenetic protein 2
The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical
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
Other Name: (rhBMP-2) (INFUSE)
Active Comparator: Autogenous iliac crest bone graft
Bone will be harvested from the iliac crest and placed in the bone defect.
Procedure: Autogenous iliac crest bone graft
Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice.
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853489
|United States, California|
|UCSF Medical Center|
|San Francisco, California, United States, 94115|
|United States, Colorado|
|Denver Health and Hospital Authority|
|Denver, Colorado, United States, 80204|
|United States, Florida|
|Florida Orthopaedic Institute / Tampa General & St. Joseph's Hospitals|
|Tampa, Florida, United States, 33606|
|United States, Iowa|
|University of Iowa Hospitals|
|Iowa City, Iowa, United States, 52242|
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55715|
|United States, Missouri|
|St. Louis Medical Center|
|St. Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28232|
|United States, Ohio|
|MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|United States, Oklahoma|
|University of Oklahoma / OU Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|Brooke Army Medical Center|
|Ft. Sam Houston, Texas, United States, 78234-6315|
|United States, Washington|
|University of Washington / Harborview Medical Center|
|Seattle, Washington, United States, 98104-2499|
|Principal Investigator:||Lisa Cannada, MD||St. Louis Medical Center|
|Principal Investigator:||Paul Tornetta, MD||Boston Medical Center|