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

Terminated

Interventions: Device: Biomet® EBI Bone Healing System
Device: Biomet Orthopak® Non-Invasive Bone Growth Stimulator System
Device: Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Stimulation Group	Biomet® EBI Bone Healing System	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.
Stimulation Group	Biomet Orthopak® Non-Invasive Bone Growth Stimulator System	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.
Stimulation Group	Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator	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.

Primary Outcome Measures

Name	Time	Method
Radiographic Assessment of Healing	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.	Bone healing was assessed on x-rays and/or CT scan.

Secondary Outcome Measures

Name	Time	Method
Quality of Life Assessment	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.	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.