NCT01016067

Tibial Delayed Healing Pivotal Clinical Trial

A Prospective, Randomized, Multicenter Pivotal Clinical Trial of the INFUSE/MASTERGRAFT™ Delayed Healing Device With Rigid Internal Fixation in the Treatment of Tibial Delayed Healing

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing.

Detailed description

The purpose of this study is to evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing. A subject will be considered to have tibial delayed healing when he/she is at least six months from the date of the most recent surgical intervention and has shown no signs of radiographic healing for at least three months. Radiographic signs of healing for this study are defined as either the progressive disappearance of fracture lines or the development of cortical continuity \[bridging bone\] at the site. All prospective patients must require surgical treatment with rigid internal fixation \[reamed IM nail or plate/screws\] and bone grafting.

Conditions

• Tibial Delayed Healing

Interventions

Type	Name	Description
DEVICE	INFUSE/MASTERGRAFT	INFUSE® (rhBMP-2) on an absorbable collagen sponge (ACS) and MASTERGRAFT® granules with appropriate rigid internal fixation hardware (reamed IM nail or plate/screws)
PROCEDURE	Autograft bone	Autogenous bone graft with appropriate rigid internal fixation hardware (reamed IM nail or plate/screws)

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-10-01
• Completion: 2013-12-01
• First posted: 2009-11-18
• Last updated: 2015-01-21
• Results posted: 2014-11-04

Locations

16 sites across 1 country: United States