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

Zimmer Biomet

Status: Terminated

Conditions: Fractures, Ununited; Fusion of Spine (Disease)

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01750840

CS-101P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

8 participants in 1 patient group

Stimulation Group

Description:

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.

Treatment:

Device: Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator

Device: Biomet Orthopak® Non-Invasive Bone Growth Stimulator System

Device: Biomet® EBI Bone Healing System