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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Fusion of Spine (Disease), Fractures, Ununited

Intervention / Treatment
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* Device: Biomet® EBI Bone Healing System
* Device: Biomet Orthopak® Non-Invasive Bone Growth Stimulator System
* Device: Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has agreed to undergo electrical stimulation therapy as prescribed by their physician. Subject has agreed to return to the physician for their physician required follow up visits. Subject will undergo treatment with Biomet's BHS, OrthoPak or SpinalPak devices. 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: Any subject not willing to comply with the physician prescribed treatment program and follow up visit schedule. Any subject not willing to complete the QoL questionnaires.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stimulation Group<br>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<br>* 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.<br>Device: Biomet Orthopak® Non-Invasive Bone Growth Stimulator System<br>* A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day.<br>Device: Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator<br>* A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day.<br>|

What is the study measuring?
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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. |