PerQdisc Traditional Feasibility Trial.
ConditionDiscogenic Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorSpinal Stabilization Technologies
About this trial
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.
Eligibility criteria
Qualifiers
Skeletally mature male or female subjects aged 22-70 (inclusive).
Subject has a primary diagnosis of single level discogenic back pain caused by degenerative disc disease (L1 to L5) identified via MRI.
Subject has an intact annulus (as determined by MRI) and endplates (as determined by MRI and X-ray) at the level to be treated.
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.).
Disqualifiers
Subject has symptomatic degenerative disc disease at more than one lumbar level
Subject has had a prior spinal fusion in the lumbar or thoracic intervertebral spaces.
Subject has had a prior SI-joint fusion.
Subject has a spinal cord stimulator.
Trial design
Treatments tested in this trial
- PerQdisc
Treatment groups
5 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov