Actively Recruiting
PerQdisc Traditional Feasibility Trial.
Led by Spinal Stabilization Technologies · Updated on 2026-05-08
5
Participants Needed
8
Research Sites
272 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PerQdisc Traditional Feasibility Trial.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 22 to 70 years
- Primary diagnosis of single-level discogenic back pain caused by degenerative disc disease (L1 to L5) confirmed by MRI
- Intact annulus and endplates at the treated level confirmed by MRI and X-ray
- Failed at least 6 months of conservative treatment for back pain
- Low back pain Visual Analog Scale (VAS) score of 40 mm (4 cm) or higher
- Adequate disc height of at least 6 mm at the treated level
- Psychosocially, mentally, and physically able and willing to comply with study requirements and follow-up
- Read and understand the informed consent document before joining
- Suitable candidate for the PerQdisc surgical approach as defined by the surgical technique guide
You will not qualify if you...
- Symptomatic degenerative disc disease at more than one lumbar level
- Prior spinal fusion in lumbar or thoracic spine
- Prior sacroiliac (SI) joint fusion
- Presence of spinal cord stimulator
- Any prior lumbar spine surgery
- Significant disc herniation at the treated level that risks expulsion
- Congenital moderate or severe spinal stenosis or epidural lipomatosis
- Spondylolisthesis greater than or equal to 3 mm or dynamic spondylolisthesis greater than or equal to 4 mm
- Range of motion greater than 20 degrees at the treated level
- History of invasive malignancy (except non-melanoma skin cancer) unless disease-free for 5 years
- Active systemic or operative site infection
- Symptomatic facet joint degeneration contributing to pain
- Allergy to silicone or barium sulfate
- Diagnosed fibromyalgia, hepatitis, rheumatoid arthritis, lupus, AIDS, ARC, HIV, or autoimmune musculoskeletal diseases
- Diagnosed Paget's disease, osteomalacia, or other metabolic bone diseases
- Substance abuse history within 1 year prior to screening
- Morbid obesity with BMI over 40
- Participation in investigational drug or device study within 30 days prior to surgery
- Osteoporosis with T-score less than or equal to -2.5
- Pregnancy or trying to become pregnant
- Diabetes requiring daily insulin
- Vulnerable populations or impaired ability to consent or comply
- Receiving worker's compensation or involved in related litigation
- Lumbar scoliosis greater than 10 degrees at treated level
- Large or irregular Schmorl's node with active inflammation
- Motion less than 3 degrees on flexion/extension radiographs at treated level
- Opioid use over 60 morphine milligram equivalent per day or recent prescription changes
- Preoperative leg pain exceeding back pain on VAS
- History of lumbar vertebral fractures
- Severe compression of cauda equina
- Chronic anticoagulation therapy that cannot be safely stopped
- Low back pain of non-spinal or unknown cause
- Unable to undergo required imaging assessments
- Degenerative muscular or neurological conditions interfering with outcome evaluation
- Behavioral, cognitive, social, or medical problems interfering with safety or effectiveness assessment
- Major psychiatric disorder impacting device assessment
- Myelopathy
- Primarily leg pain with nerve root compression
- Annular defect over 6 mm extending to outer annulus margin on MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Hope Research Institute
Glendale, Arizona, United States, 85308
Withdrawn
2
The CORE Institute
Phoenix, Arizona, United States, 85023
Actively Recruiting
3
HOPE Research Institute
Phoenix, Arizona, United States, 85032
Withdrawn
4
HonorHealth Research & Innovation Institute
Scottsdale, Arizona, United States, 85251
Actively Recruiting
5
Axis Spine Center
Coeur d'Alene, Idaho, United States, 83854
Actively Recruiting
6
Indiana Spine Group
Carmel, Indiana, United States, 46032
Actively Recruiting
7
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101
Actively Recruiting
8
SonoSpine
Oklahoma City, Oklahoma, United States, 73159
Withdrawn
Research Team
M
Molly Bond
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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