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



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2014
End Date:December 2017

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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

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

The purpose of this clinical registry is to capture recent data (i.e., Arm 1 - information
on patients treated by the physician in previous 3 years and Arm 2 - any new patients being
treated by the physician) from the patient medical records of those who have been treated or
are being treated with a Biomet® EBI Bone Healing System (BHS), Biomet® OrthoPak®
Non-Invasive Bone Growth Stimulator System, or the Biomet® SpinalPak® Non-Invasive Spine
Fusion Stimulator System. While electrical stimulation (PEMF & CC) has been utilized
increasingly by physicians since the first FDA approved device came to market in 1979,
questions remain regarding patient outcomes and the health economics associated with these
technologies. A recent burden of illness study showed strong cost efficiency data for the
electrical stimulators, but did not address clinical or patient outcomes.

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.
We found this trial at
6
sites
Vineland, New Jersey 08360
Principal Investigator: Richard Jay, DPM
Phone: 856-696-2010
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Frisco, Texas 75034
Principal Investigator: Sarang Desai, MD
Phone: 972-985-1072
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Frisco, TX
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New York, New York 10023
Principal Investigator: Rosanna Troia, DPM
Phone: 212-877-1002
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New York, NY
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Philadelphia, Pennsylvania 19114
Principal Investigator: Justin Fleming, DPM
Phone: 215-464-6600
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Philadelphia, PA
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PIttsburgh, Pennsylvania 15212
Phone: 412-359-4134
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PIttsburgh, PA
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Plantation, Florida 33324
Principal Investigator: Warren Windram, MD
Phone: 954-476-8800
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Plantation, FL
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