Trials / Unknown
UnknownNCT05101057
A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients
A Retrospective Study to Examine the Effect of Adjuvant Combined Magnetic Field Stimulation on Primary Anterior Cervical Discectomy and Fusion (ACDF) Patients
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (estimated)
- Sponsor
- Encore Medical, L.P. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SpinalogicTM Bone Graft Stimulator | The SpinalogicTM is a portable, battery-powered, microprocessor-controlled, non-invasive bone growth stimulator. The device is currently approved and commercially indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. |
Timeline
- Start date
- 2021-11-15
- Primary completion
- 2022-03-01
- Completion
- 2022-06-01
- First posted
- 2021-11-01
- Last updated
- 2021-12-07
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05101057. Inclusion in this directory is not an endorsement.