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

This study has been terminated.
(Slow enrollment and poor patient follow-up following enrollment)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01750840
First received: December 13, 2012
Last updated: May 5, 2016
Last verified: March 2016
  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.

Condition Intervention
Fusion of Spine (Disease)
Fractures, Ununited
Device: Biomet® EBI Bone Healing System
Device: Biomet Orthopak® Non-Invasive Bone Growth Stimulator System
Device: Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator

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:
  • Radiographic Assessment of Healing [ Time Frame: The time frame for healing determination was not pre-specified. Patients were evaluated at regular doctors' visits for up to 12 months. The physician determined the time point at which healing occurred for each patient at their regular visits. ] [ Designated as safety issue: No ]
    Bone healing was assessed on x-rays and/or CT scan.


Secondary Outcome Measures:
  • Quality of Life Assessment [ Time Frame: The quality of life assessment was to be completed at the regular doctor's visit at which the physician determined the patient to be healed. No quality of life data was collected. ] [ Designated as safety issue: No ]
    Quality of life was intended to be measured by 5 scoring systems that ask a range of questions about the patient's pain and function. No quality of life data was captured for any of the patients and as such no quality of life analysis was performed.


Enrollment: 8
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Device: Biomet® EBI Bone Healing System
A pulsed electromagnetic fields electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 3-10 hours per day with a recommended use of 10 hours per day.
Device: Biomet Orthopak® Non-Invasive Bone Growth Stimulator System
A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day.
Device: Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator
A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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, New Jersey
Cumberland Orthopedics
Vineland, New Jersey, United States, 08360
Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Director: Randy Graham Biomet, Inc.
  More Information

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01750840     History of Changes
Other Study ID Numbers: CS-101P 
Study First Received: December 13, 2012
Results First Received: March 9, 2016
Last Updated: May 5, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Fractures, Ununited
Fractures, Bone
Wounds and Injuries
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 28, 2016