Vineland, New Jersey 08360

  • Fractures, Ununited

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: 1. Subject has agreed to undergo electrical stimulation therapy as prescribed by their physician. 2. Subject has agreed to return to the physician for their physician required follow up visits. 3. Subject will undergo treatment with Biomet's BHS, OrthoPak or SpinalPak devices. 4. Subject has agreed to complete QoL questionnaires prior to starting treatment and at the follow up visit when the physician has determined the subject to be either healed or failed. Exclusion Criteria: 1. Any subject not willing to comply with the physician prescribed treatment program and follow up visit schedule. 2. Any subject not willing to complete the QoL questionnaires.


NCT ID:

NCT01750840


Primary Contact:

Study Director
Randy Graham
Zimmer Biomet


Backup Contact:

N/A


Location Contact:

Vineland, New Jersey 08360
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 16, 2021

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