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Tibial Delayed Healing Pivotal Clinical Trial

2014-07-10 14:11:17 | BioPortfolio

Summary

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Tibial Delayed Healing

Intervention

INFUSE/MASTERGRAFT, Autograft bone

Location

Denver Health
Denver
Colorado
United States
80204

Status

Terminated

Source

Medtronic Spinal and Biologics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-10T14:11:17-0400

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