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CAUTION - Investigational device.
Limited by United States law to investigational use.
There are numerous options available to help treat lumbar Degenerative Disc Disease (DDD) including: physical therapy, lifestyle modifications, non-steroidal anti-inflammatory medications like ibuprofen, epidural injections, etc. However, when non-surgical treatments have failed, surgery may be considered. Spinal fusion and/or total disc replacement (TDR) are often performed when the disc is severely damaged.
The PerQdisc™ Nucleus Replacement is different. It aims to restore disc function and alleviate pain potentially preventing progression of DDD.
PerQdisc™ Nucleus Replacement System
Recreates physiological motion and
redistributes the disc’s weight-bearing
forces and mechanical properties in
a more natural fashion
Precision
Silicone-based, form-fitting
Custom Implant
PerQdisc Implant Delivery Device
FDA acclaimed - Breakthrough
Technology
Innovative Technology
About PerQdisc
The Disc Nucleus Replacement System
The PerQdisc offers an innovative, potentially less invasive lumbar spine disc nucleus replacement for chronic low back pain associated with degenerative disc changes. The patented PerQdisc™ device replaces the physical space of the nucleus pulposus and mimics the biomechanics of the native disc.
The PerQdisc is a custom, form-fitting, medical grade silicone-based implant. The PerQdisc does not require screws or rods and is implanted through a small surgical incision on the side of the body via the PerQdisc Implant Delivery Device.
The PerQdisc replaces the middle part of the disc while preserving the outside structural part of the disc (disc fibers) and other parts of the spine.
Flexion X-ray with PerQdisc in place.
Potential Benefits of the PerQdisc
may include but are not limited to:
• Reduced Pain (1)
(back and leg pain if present)
• Improved/Restored Disc Function (1)
• Return to Work/resume daily routines (1)
1. Lumbar Disc Nucleus Replacement for Refractory Back Pain: A Case Report.
Journal of Spine Research and Surgery 5 (2023): 65-68.
Extension X-ray with PerQdisc in place.
Pre & Post-Op
LOPAIN2
LOPAIN2
Could you qualify for a PerQdisc clinical trial?
Patients may be eligible if:
• You are between 22-70 years old
• You have low back pain that is caused by degeneration of one of the discs in your lumbar spine (low back) confirmed by MRI
• You have not improved after completing at least 6 months of non-surgical / conservative treatment for your back pain (e.g., physical therapy, medical injections, ablations, lifestyle changes, etc.)
• This self-screening test is a preliminary tool to help determine if you may qualify for further evaluations.
If you are interested in participating in this study, further screenings and evaluations are required to confirm eligibility.
What would be your commitment?
If you qualify for the study, are selected and choose to participate, you will be followed by the research team for up to 60 months (5 years) after your surgery. You will be asked to return to the clinic for regular follow-up visits during that timeframe for medical evaluations. These visits will occur at approximately 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and then annually up to five years post-surgery. These visits help your doctor and research staff understand how well the device performs over time and identify any possible risks associated with the use of the device or the procedure.
Take the Initial Self-Screening Test
What are the risks?
If you are interested in enrolling in the study, you will be asked to sign an Informed Consent form that outlines all known risks and side effects. The study physician will also review this with you before you decide to participate.
Click below for complete lists of Patient Qualifications and Risks Associated with the PerQdisc Nucleus Replacement:
Degenerative Disc Disease - DISCPAIN1
Degenerative Disc Disease - LOPAIN2
Download Informational Brochure
about the DISCPAIN1 Clinical Trial
Clinical Sites and Physicians
To see if there's a clinical site and participating physician in your area,
visit: Clinicaltrials.gov
Clinical Trials
Nucleus 181 – Closed
Safety Study for a Lumbar Spine Disc Nucleus Replacement (PerQdisc).
N181 is a clinical trial to study the safety of implanting PerQdisc device in the lumbar spine of patients suffering from chronic low back pain. Patients are assessed for pain and disability using standardized patient reported outcome measures as well as X-ray and MRI imaging. (Click here for more information)
LOPAIN1 – Closed
Safety Study for a Lumbar Spine Disc Nucleus Replacement (PerQdisc).
LOPAIN1 is a clinical trial designed to study the safety and efficacy of the PerQdisc device in patients suffering from chronic low back pain due to one or more degenerated lumbar discs. Patients are assessed for pain and disability using standardized patient reported outcome measures as well as X-ray and MRI imaging.
(Click here for more information)
LOPAIN2 – Enrolling: Latin America, Asia
Safety Study for a Lumbar Spine Disc Nucleus Replacement (PerQdisc).
LOPAIN2 is a clinical trial designed to study the safety and efficacy of implanting the PerQdisc device in patients suffering from chronic low back pain due to one or more degenerated lumbar discs. Patients are assessed for pain and disability using standardized patient reported outcome measures as well as X-ray and MRI imaging. (Click here for more information)
LOPAIN3 – On Hold
Safety Study for a Lumbar Spine Disc Nucleus Replacement (PerQdisc).
LOPAIN3 is a clinical trial designed to gather clinical data on the feasibility, safety, and efficacy of performing the PerQdisc procedure concurrently following successful discectomy, using a minimally invasive posterolateral (MIPL) approach in patients presenting with symptomatic radiculopathy from a focal lumbar disc herniation that requires surgical decompression. Patients are assessed for pain and disability using standardized patient reported outcome measures as well as X-ray and MRI imaging. (Click here for more information)
DISCPAIN1 – Enrolling: United States
Feasibility Study for a Lumbar Spine Disc Nucleus Replacement (PerQdisc).
DISCPAIN1 is a traditional feasibility study (TFS) study to evaluate the safety and effectiveness of the PerQdisc device in the treatment of patients suffering from single level discogenic back pain caused by degenerative disc disease. Patients are assessed for pain and disability using standardized patient reported outcome measures as well as X-ray and MRI imaging. (Click here for more information)
Self Screening Test
This is a self screening test. No data is being collected or saved from this test.
Testimonials
Spinal Stabilization Technologies, Ltd. are trademarks of Spinal Stabilization Technologies, Ltd, PerQdisc™ Nucleus Replacement System. The PerQdisc Nucleus Replacement System is currently not FDA-approved or for sale in the United States. The Spinal Stabilization Technologies PerQdisc is not approved for sale in regions that accept the CE Mark.
This website includes materials for general information and educational purposes only. It is not intended to provide medical diagnosis or medical services. Consult your healthcare provider for medical diagnosis and treatment options.
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