PerQdisc Traditional Feasibility Trial.

Recruiting now · Not applicable

Conditions studied: Discogenic Low Back Pain

In brief

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.

Key facts

Study ID

NCT06860867

Run by

Spinal Stabilization Technologies

People needed

5

Starts

2025-01-10

Expected to finish

2030-03-31

Last updated by the study team

2026-05-08

Who can join

Age: 22 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.).
• Subject has a low back pain VAS ≥40 mm (4 cm).
• Subject has adequate disc height (≥6mm measured at the center of the disc) at the level to be treated. [As measured by the investigator]
• Subject is psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
• Subject has read and understands the IRB approved informed consent document prior to signing and dating the document and before the initiation of any study-related procedures
• Subject is appropriate candidate for the PerQdisc surgical approach [as defined in the surgical technique guide].

You may not qualify if…

• 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.
• Subject has had any prior lumbar spine surgery (instrumented or non-instrumented)
• Subject has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion.
• Subject has congenital moderate or severe spinal stenosis or epidural lipomatosis.
• Subject has spondylolisthesis (antero- or retrolisthesis) in static X-ray ≥3 mm [measured via neutral lateral x-ray]
• Subject has ≥4 mm dynamic spondylolisthesis [measured via flexion/extension x-rays]
• Subject has > 20 degree range of motion at the index level [measured via flexion/extension x-rays]
• Subject has a history of any invasive malignancy (except non-melanoma skin cancer) unless treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years (in particular, spinal tumors).
• Subject has an active systemic infection or infection at the operative site.
• Subject has evidence of symptomatic facet joint degeneration or disease where the investigator feels the facet is a major contributor to the subject's pain as diagnosed by injection and/or imaging.
• Subject has a known allergy to silicone or barium sulfate.
• Subject has been diagnosed with fibromyalgia, hepatitis, rheumatoid arthritis, lupus erythematosus, AIDs, ARC, HIV, or an autoimmune disease that affects the musculoskeletal system.
• Subject has been diagnosed with Paget's disease, osteomalacia or any other metabolic bone disease.
• Subject has current or recent history (defined ≤ 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) using standard medical definitions of DSM-5
• Subject has morbid obesity defined as a body mass index (BMI) > 40.
• Subject participated in an investigational drug or another medical device study within the last 30 days prior to surgery.
• Subject has Osteoporosis, defined as a T-score ≤ -2.5.
• An existing DEXA is allowed if completed within 6 months of subject surgery.
• For all subjects without an existing DEXA, the SCORE/MORES will be utilized to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scan is required.
• Female subjects who are pregnant or are trying to become pregnant during the course of the trial.
• Subject has diabetes mellitus (Type 1 or 2) requiring daily insulin management.
• Subject belongs to a vulnerable population or has a condition such that his/her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g. developmentally disabled, prisoner, chronic alcohol/ substance abuser)

Where it is running

• Indiana Spine Group — Carmel, Indiana, United States (enrolling)
• Spine Institute of Louisiana — Shreveport, Louisiana, United States (enrolling)
• The CORE Institute — Phoenix, Arizona, United States (enrolling)
• HonorHealth Research & Innovation Institute — Scottsdale, Arizona, United States (enrolling)
• Axis Spine Center — Coeur d'Alene, Idaho, United States (enrolling)
• SonoSpine — Oklahoma City, Oklahoma, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• Hope Research Institute — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.