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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01750840
First received: December 13, 2012
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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.


Condition
Non Union or Failed Fusion in the Appendicular System
Spinal Fusion

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Clinical Healing [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    We will be assessing clinical healing at all visits. Patients will continue in this registry until the 12 month visit, unless they have been deemed healed or failed, up to the 12 month time point.

  • Radiographic Healing [ Time Frame: 12 Month ] [ Designated as safety issue: No ]
    We will be assessing radiographic healing at all visits. Patients will continue in this registry until the 12 month visit, unless they have been deemed healed or failed, up to the 12 month time point.


Estimated Enrollment: 1000
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stimulation Group
All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This clinical registry will be a prospective, multi-center study Subjects will undergo treatment with Biomet's BHS or OrthoPak devices for non-spinal applications.

Subjects will undergo treatment with Biomet's SpinalPak for spinal applications

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750840

Locations
United States, Florida
Orthopedic Associates USA Recruiting
Plantation, Florida, United States, 33324
Contact: Lanie Stark    954-476-8800    starkhe@oausa.com   
Principal Investigator: Warren Windram, MD         
United States, New Jersey
Cumberland Orthopedics Recruiting
Vineland, New Jersey, United States, 08360
Contact: Lauryn Smith, DPM    856-696-2010    laurynsmith@comcast.net   
Principal Investigator: Richard Jay, DPM         
United States, New York
Goldsmith Podiatry Recruiting
New York, New York, United States, 10023
Contact: Rosanna Troia, DPM    212-877-1002    rtroiadpm@yahoo.com   
Principal Investigator: Rosanna Troia, DPM         
United States, Pennsylvania
Northeast Orthopedic Specialists Recruiting
Philadelphia, Pennsylvania, United States, 19114
Contact: Justin Fleming, MD    215-464-6600    flemingjmak@gmail.com   
Principal Investigator: Justin Fleming, DPM         
Allegheny Health Network Recruiting
PIttsburgh, Pennsylvania, United States, 15212
Contact: Tracy Salerno    412-359-4134    tsalerno@wpahs.org   
Sub-Investigator: Daniel Altman, MD         
Principal Investigator: Gregory Altman, MD         
United States, Texas
Ortho Texas Recruiting
Frisco, Texas, United States, 75034
Contact: Sarang Desai, MD    972-985-1072    sarangdesai@gmail.com   
Principal Investigator: Sarang Desai, MD         
Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Chair: Betsy Lowwy Biomet, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01750840     History of Changes
Other Study ID Numbers: CS-101P
Study First Received: December 13, 2012
Last Updated: March 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Biomet, Inc.:
non union
failed fusion
spine
long bone
short bone

Additional relevant MeSH terms:
Cimetidine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014