rhBMP-2 Versus Autograft in Critical Size Tibial Defects

NCT00853489 | Terminated Phase 4 Results DMC

• 2 other identifiers: W81XWH-09-2010815915
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 13

Brief 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).

Conditions

Tibial Fractures

Keywords

Open tibia fractures; rhBMP-2; critical size defects; bone grafting

Outcome Measures

Primary Outcomes (1)

• Fracture Healing (Union) at 12 Months

  Union will be defined by: 1\. Radiographic union as defined by the Radiographic union scale in tibia fractures (RUST) score, Radiographic evaluation will be assessed by blinded orthopaedic surgeons.

  12 months post op

Secondary Outcomes (2)

• Infection

  12 months post op.

• Medical Cost

  12 mos post op

Study Arms (2)

recombinant bone morphogenetic protein 2

EXPERIMENTAL

The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical

Device: recombinant bone morphogenetic protein 2

Autogenous iliac crest bone graft

ACTIVE COMPARATOR

Bone will be harvested from the iliac crest and placed in the bone defect.

Procedure: Autogenous iliac crest bone graft

Interventions

recombinant bone morphogenetic protein 2 DEVICE

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

Also known as: (rhBMP-2) (INFUSE)

recombinant bone morphogenetic protein 2

Autogenous iliac crest bone graft PROCEDURE

Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice.

Autogenous iliac crest bone graft

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18-65 years old with an open tibia fracture involving diaphysis (if patient has a bilateral tibia fracture and both require a bone graft, then each will be randomized separately).
• Tibia fractures with a circumferential bone defect of at least one centimeter in length compromising at least 50% of the circumference of the bone.
• The definitive treatment of the tibia fracture must be with an intramedullary nail (may have temporary external fixation prior to IM nail placement).
• Patients whose treatment plan includes placement of a bone graft between 6 to 16 weeks after their initial injury.
• Patients who have no evidence of infection by clinical examination (defined as active infection at the operative site, purulent drainage from the fracture or evidence of active osteomyelitis at the time of bone graft).
• Patients who are independent in living and ambulation prior to injury.
• Patients who are English speaking.
• Patients who are willing to provide consent and available for follow-up for at least 12 months following definitive surgical procedure.

You may not qualify if:

• Patients who are pregnant or lactating.
• Patients with known hypersensitivity to rhBMP-2 or bovine type I collagen.
• Patients with a history of tumor, a resected or extant tumor, an active malignancy, or patients undergoing treatment for malignancy.
• Patients who are skeletally immature (\<18 years of age or no radiographic evidence of epiphyseal closure).
• Patients with inadequate neurovascular status, e.g. high risk of amputation.
• Patients with compartment syndrome of the affected limb.
• Patients with immune deficiency or history of auto-immune disease,
• Patients who have undergone treatment of any other investigational therapy within the month preceding implantation or planned within the 12 months following implantation.
• Patients unable to return for required follow-up visits.
• Patients who have medical co-morbidities that preclude treatment with a general anesthetic.
• Patient who is pending incarceration or who is incarcerated.
• Patients with an active infection at the operative site, purulent drainage from the fracture or evidence of active osteomyelitis at the time of bone grafting.
• Patient has intraoperative positive gram stain or an elevated CRP after laboratory screening for infection.
• Patient has segmental defects longer than 5cm in length.
• Patients who have segmental defects that require more than 60 cc of bone graft.

Sponsors & Collaborators

• St. Louis University: lead
• Major Extremity Trauma Research Consortium: collaborator

Study Sites (13)

UCSF Medical Center

San Francisco, California, 94115, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Florida Orthopaedic Institute / Tampa General & St. Joseph's Hospitals

Tampa, Florida, 33606, United States

Location

University of Iowa Hospitals

Iowa City, Iowa, 52242, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55715, United States

Location

St. Louis Medical Center

St Louis, Missouri, 63110, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28232, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

University of Oklahoma / OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234-6315, United States

Location

University of Washington / Harborview Medical Center

Seattle, Washington, 98104-2499, United States

Location

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Results Point of Contact

• Title: Dr. Lisa Kaye Cannada
• Organization: Saint Louis University

LCannada@slu.edu

3145778850

Study Officials

• Thomas Revak, DO

  St. Louis Medical Center

  PRINCIPAL INVESTIGATOR

• Paul Tornetta, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: February 24, 2009
• First Posted: March 2, 2009
• Study Start: August 1, 2011
• Primary Completion: February 17, 2017
• Study Completion: February 17, 2017
• Last Updated: October 25, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-10

Locations

US (13)