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

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 Biomet's BHS, OrthoPak and SpinalPak devices.

Study Overview

• Status: Terminated
• Conditions: Fractures, Ununited; Fusion of Spine (Disease)
• Intervention / Treatment: Device: Biomet® EBI Bone Healing System; Device: Biomet Orthopak® Non-Invasive Bone Growth Stimulator System; Device: Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator

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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Vineland, New Jersey, United States, 08360
      • Cumberland Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Assessment of Healing	Bone healing was assessed on x-rays and/or CT scan.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Assessment	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.	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.

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Randy Graham, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (ESTIMATE): December 17, 2012

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Ununited; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Cytochrome P-450 Enzyme Inhibitors; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Cytochrome P-450 CYP1A2 Inhibitors; Histamine H2 Antagonists; Cimetidine
• Other Study ID Numbers: CS-101P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED