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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

Page last updated: August 23, 2015

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