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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-10-31

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.

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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.

Conditions

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Fusion of Spine (Disease) Fractures, Ununited

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biomet® EBI Bone Healing System

Intervention Type DEVICE

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.

Biomet Orthopak® Non-Invasive Bone Growth Stimulator System

Intervention Type DEVICE

A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day.

Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator

Intervention Type DEVICE

A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No