A Study of INFUSE Bone Graft (BMP-2) in the Treatment of Tibial Pseudarthrosis in Neurofibromatosis Type 1 (NF1)

NATerminatedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

March 1, 2016

Primary Completion Date

June 1, 2020

Study Completion Date

June 1, 2020

Conditions
NF1Congenital Pseudarthrosis of Tibia
Interventions
DEVICE

INFUSE Bone Graft (BMP-2)

The INFUSE bone graft, containing BMP-2 on a collagen sponge, will be wrapped around the tibia during the surgical process.

PROCEDURE

Control Group

The control group will receive the standard surgical protocol, without addition of the INFUSE device.

Trial Locations (16)

2145

The Children's Hospital at Westmead, Westmead

10016

New York University Medical Center, New York

19096

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

21287

Johns Hopkins, Baltimore

35294

The University of Alabama at Birmingham, Birmingham

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Indiana Unversity, Indianapolis

60611

Children's Lurie Hospital, Chicago

60637

University of Chicago, Chicago

63130

Washington University in St. Louis, St Louis

75235

Texas Scottish Rite Hospital for Children, Dallas

84132

University of Utah, Salt Lake City

90027

Children's Hospital Los Angeles, Los Angeles

02115

Children' Hospital Boston and Massachusetts General Hospital, Boston

Children' Hospital Boston, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

The Children's Tumor Foundation

OTHER

collaborator

Medtronic

INDUSTRY

lead

University of Alabama at Birmingham

OTHER