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

Fusion of Spine (Disease) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01750840
• Other study ID #: CS-101P
• Status: Terminated
• Phase: N/A
• First received: December 13, 2012
• Last updated: June 16, 2017
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Ununited
• Fusion of Spine (Disease)

Intervention

Device:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Cumberland Orthopedics	Vineland	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.