A Prospective Clinical Registry to Collect Patient Outcome Date for the BIOMET® Stimulator Systems
The purpose of this open prospective patient registry is to capture data on an ongoing basis from a population of patients who will use any of Biomet's BHS, OrthoPak and SpinalPak devices. While electrical stimulation has been utilized increasingly by physicians since the first FDA approved unit came to market in 1979, questions remain regarding patient outcomes and the health economics associated with this technology as a class. A recent burden of illness study showed strong cost efficiency data for the electrical stimulators, but did not address clinical or patient outcomes.
Non Union or Failed Fusion in the Appendicular System
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||12 Months|
|Official Title:||A Prospective 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 Healing [ Time Frame: 12 Months ] [ Designated as safety issue: No ]We will be assessing clinical 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.
- Radiographic Healing [ Time Frame: 12 Month ] [ Designated as safety issue: No ]We will be assessing 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.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
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.
|United States, New Jersey|
|Vineland, New Jersey, United States, 08360|
|Contact: Lauryn Smith, DPM 856-696-2010 firstname.lastname@example.org|
|Principal Investigator: Richard Jay, DPM|
|Study Chair:||Betsy Lowwy||Biomet, Inc.|