A Multi-center Traditional Feasibility Trial of the PerQdisc Artificial Implant in Treatment of Single-level Discogenic Back Pain.
Spinal Stabilization Technologies
Summary
This is a traditional feasibility study (TFS) study to evaluate the safety and effectiveness of the PerQdisc. The study is prospective, multicenter, and open label. After a screening period, qualified participants will be enrolled and treated with the PerQdisc. Patients will not be blinded to their treatment. Participants will then complete the safety follow-up period.
Description
The proposed investigation is a multicenter, prospective, traditional feasibility study of the PerQdisc. A minimum of N=5 subjects will be enrolled. Subjects will be enrolled in approximately 2 sites. Data analyses including all enrolled subjects meeting specific criteria will be submitted to the FDA to support a pivotal trial and used in trial planning. This study will evaluate the safety and effectiveness of the PerQdisc device in the treatment of single level discogenic back pain caused by degenerative disc disease (DDD) (L1 to L5).
Eligibility
- Age range
- 22–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Skeletally mature male or female subjects aged 22-70 (inclusive). 2. Subject has a primary diagnosis of single level discogenic back pain caused by degenerative disc disease (L1 to L5) identified via MRI. 3. Subject has an intact annulus (as determined by MRI) and endplates (as determined by MRI and X-ray) at the level to be treated. 4. Subject must have failed to respond to a minimum of 6 months of conservative treatment for their back pain (e.g., physical therapy, medications, injections, ablations, lifestyle changes, etc.). 5. Subject has a low back pain VAS ≥40 mm (…
Interventions
- DevicePerQdisc
PerQdisc Artificial Implant
Locations (8)
- Hope Research InstituteGlendale, Arizona
- The CORE InstitutePhoenix, Arizona
- HOPE Research InstitutePhoenix, Arizona
- HonorHealth Research & Innovation InstituteScottsdale, Arizona
- Axis Spine CenterCoeur d'Alene, Idaho
- Indiana Spine GroupCarmel, Indiana