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

Zimmer Biomet8 enrolled

Overview

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.

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

Conditions

Fusion of Spine (Disease)Fractures, Ununited

Interventions

Biomet® EBI Bone Healing SystemDEVICE

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 SystemDEVICE

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 StimulatorDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cumberland Orthopedics

Vineland, New Jersey, United States

Outcomes

Primary Outcomes

Radiographic Assessment of Healing

Bone healing was assessed on x-rays and/or CT scan.

Time frame: 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 Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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