Vineland, New Jersey 08360

  • Fractures, Ununited

Purpose:

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.


Study summary:

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.


Criteria:

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.


Study is Available At:


Original ID:

CS-101P


NCT ID:

NCT01750840


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Zimmer Biomet


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Slow enrollment and poor patient follow-up f


Study Type:

Observational [Patient Registry]


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

8


Enrollment Type:

Actual


Overall Contact Information

Official Name:Randy Graham
Study Director
Zimmer Biomet

Study Dates

Start Date:October 2012
Completion Date:October 2013
Completion Type:Actual
Primary Completion Date:October 2013
Primary Completion Type:Actual
Verification Date:June 2017
Last Changed Date:June 16, 2017
First Received Date:December 13, 2012
First Results Date:March 9, 2016

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Quality of Life Assessment
Time Frame:The quality of life assessment was to be completed at the regular doctor's visit at which the physic
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Radiographic Assessment of Healing
Time Frame:The time frame for healing determination was not pre-specified. Patients were evaluated at regular d
Safety Issues:False
Description:Bone healing was assessed on x-rays and/or CT scan.

Study Interventions

Intervention Type:Device
Name:Biomet SpinalPak® Non-Invasive Spine Fusion Stimul
Description:A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day.
Arm Name:Stimulation Group
Intervention Type:Device
Name:Biomet Orthopak® Non-Invasive Bone Growth Stimulat
Description:A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day.
Arm Name:Stimulation Group
Intervention Type:Device
Name:Biomet® EBI Bone Healing System
Description: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.
Arm Name:Stimulation Group

Study Arms

Study Arm Type:Other
Arm Name: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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Zimmer Biomet

Samples and Retentions

Study Population: This clinical registry will be a prospective, multi-center study. Subjects will undergo treatment with Biomet's BHS or OrthoPak devices for non-spinal applications. Subjects will undergo treatment with Biomet's SpinalPak for spinal applications
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 29, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.