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

NCT01750840 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2017-06-19

Study results available
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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.

Conditions

  • Fusion of Spine (Disease)
  • Fractures, Ununited

Interventions

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.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Randy Graham · Zimmer Biomet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01750840 on ClinicalTrials.gov