NCT01750840

A Clinical Registry to Collect Patient Outcome Date for the BIOMET® Stimulator Systems

A Clinical Registry to Collect Patient Outcome Data for the BIOMET® EBI Bone Healing System, BIOMET® OrthoPak® Non-invasive Bone Growth Stimulator System, and the BIOMET® SpinalPak® Non-Invasive Spine Fusion Stimulator System

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical registry is to capture data on an ongoing basis from a population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices.

Detailed description

The purpose of this clinical registry is to capture current, real-world, bone specific healing data from the medical records of patients being treated with a Biomet® EBI Bone Healing System (BHS), the Biomet® OrthoPak® Non-Invasive Bone Growth Stimulator System, or the Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System. This study will provide current data on the effectiveness of these electrical stimulation devices.

Conditions

• Fusion of Spine (Disease)
• Fractures, Ununited

Interventions

Type	Name	Description
DEVICE	Biomet® EBI Bone Healing System	A pulsed electromagnetic fields electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 3-10 hours per day with a recommended use of 10 hours per day.
DEVICE	Biomet Orthopak® Non-Invasive Bone Growth Stimulator System	A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day.
DEVICE	Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator	A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-12-17
• Last updated: 2017-06-19
• Results posted: 2016-06-14

Locations

1 site across 1 country: United States