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