A Clinical Registry to Collect Patient Outcome Date for the BIOMET® Stimulator Systems
|ClinicalTrials.gov Identifier: NCT01750840|
Recruitment Status : Terminated (Slow enrollment and poor patient follow-up following enrollment)
First Posted : December 17, 2012
Results First Posted : June 14, 2016
Last Update Posted : June 19, 2017
|Condition or disease||Intervention/treatment|
|Fusion of Spine (Disease) Fractures, Ununited||Device: Biomet® EBI Bone Healing System Device: Biomet Orthopak® Non-Invasive Bone Growth Stimulator System Device: Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||8 participants|
|Target Follow-Up Duration:||12 Months|
|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|
|Study Start Date :||October 2012|
|Primary Completion Date :||October 2013|
|Study Completion Date :||October 2013|
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.
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.Device: 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.Device: 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750840
|United States, New Jersey|
|Vineland, New Jersey, United States, 08360|
|Study Director:||Randy Graham||Zimmer Biomet|