A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients
- Conditions
- Degeneration of Cervical Intervertebral Disc
- Interventions
- Device: SpinalogicTM Bone Graft Stimulator
- Registration Number
- NCT05101057
- Lead Sponsor
- Encore Medical, L.P.
- Brief Summary
A retrospective parallel group comparison study to support expansion of the indication of the company's FDA approved Spinalogic™ device to include the cervical spine. The SpinalogicTM device was initially approved by FDA as an adjunct to one- or two-level lumbar fusion (P910066/S011). It is a non-invasive bone growth stimulator (BGS) that generates a combined magnetic field (CMF) that has been proven to accelerate bone healing and fusion in the lumbar spine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treated SpinalogicTM Bone Graft Stimulator Patients who underwent ACDF surgery and who received post surgical therapy with the SpinalogicTM Non-Invasive Bone Graft Stimulation Device.
- Primary Outcome Measures
Name Time Method Time to fusion 12 months Comparison of the cervical fusion rate between treated and control group patients
- Secondary Outcome Measures
Name Time Method Patient Reported Outcome Measures VAS 12 months VAS Pain Score
Patient Reported Outcome Measures NDI 12 months Neck Disability Index
Patient Reported Outcome Measures OC 12 months Odum's Criteria
Trial Locations
- Locations (2)
SIOSD
🇺🇸San Diego, California, United States
BSSNY
🇺🇸White Plains, New York, United States