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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Fusion of Spine (Disease)
- Sponsor
- Zimmer Biomet
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Radiographic Assessment of Healing
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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 Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has agreed to undergo electrical stimulation therapy as prescribed by their physician.
- •Subject has agreed to return to the physician for their physician required follow up visits.
- •Subject will undergo treatment with Biomet's BHS, OrthoPak or SpinalPak devices.
- •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
- •Any subject not willing to comply with the physician prescribed treatment program and follow up visit schedule.
- •Any subject not willing to complete the QoL questionnaires.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Quality of Life Assessment(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.)