A Clinical Registry to Collect Patient Outcome Date for the BIOMET® Stimulator Systems
Information source: Biomet, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fusion of Spine (Disease); Fractures, Ununited
Phase: N/A
Status: Recruiting
Sponsored by: Biomet, Inc. Official(s) and/or principal investigator(s): Joel Batts, Study Director, Affiliation: Biomet, Inc.
Summary
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.
Clinical Details
Official title: 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
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Quality of Life Assessment
Secondary outcome: Radiographic Assessment
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Orthopedic Associates USA, Plantation, Florida 33324, United States; Recruiting Lanie Stark, Phone: 954-476-8800, Email: starkhe@oausa.com Warren Windram, MD, Principal Investigator
Cumberland Orthopedics, Vineland, New Jersey 08360, United States; Recruiting Lauryn Smith, DPM, Phone: 856-696-2010, Email: laurynsmith@comcast.net Richard Jay, DPM, Principal Investigator
Goldsmith Podiatry, New York, New York 10023, United States; Recruiting Rosanna Troia, DPM, Phone: 212-877-1002, Email: rtroiadpm@yahoo.com Rosanna Troia, DPM, Principal Investigator
Northeast Orthopedic Specialists, Philadelphia, Pennsylvania 19114, United States; Recruiting Justin Fleming, MD, Phone: 215-464-6600, Email: flemingjmak@gmail.com Justin Fleming, DPM, Principal Investigator
Allegheny Health Network, PIttsburgh, Pennsylvania 15212, United States; Recruiting Tracy Salerno, Phone: 412-359-4134, Email: tsalerno@wpahs.org Daniel Altman, MD, Sub-Investigator Gregory Altman, MD, Principal Investigator
Ortho Texas, Frisco, Texas 75034, United States; Recruiting Sarang Desai, MD, Phone: 972-985-1072, Email: sarangdesai@gmail.com Sarang Desai, MD, Principal Investigator
Additional Information
Starting date: January 2014
Last updated: August 15, 2014
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