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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational [Patient Registry]

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

Brief 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.

Detailed 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.
Sponsor: Zimmer Biomet

Current Primary Outcome: Radiographic Assessment of Healing [ 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. ]

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


Original Primary Outcome: Clinical and Radiographic Healing [ Time Frame: 12 Month ]

We will be assessing clinical and radiographic healing at all visits. Patients will continue in this registry until the 12 month visit, unless they have been deemed healed or failed, up to the 12 month time point.


Current Secondary Outcome: Quality of Life Assessment [ 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. ]

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.


Original Secondary Outcome:

Information By: Zimmer Biomet

Dates:
Date Received: December 13, 2012
Date Started: October 2012
Date Completion:
Last Updated: May 5, 2016
Last Verified: March 2016