What is the PerQdisc device studying for degenerative disc disease?

The PerQdisc Nucleus Replacement System is being studied to collect safety and effectiveness data in patients with degenerative disc disease causing chronic low back pain. Researchers want to see if the device can maintain disc height and preserve spinal motion while reducing pain. The study is sponsored by Spinal Stabilization Technologies.

Who may be eligible for this degenerative disc disease clinical trial?

Adults aged 22 to 70 years with degenerative disc disease affecting one lumbar disc may be eligible. Participants must have had at least 6 months of conservative back pain treatment and meet specific pain and disability levels. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this degenerative disc disease clinical trial?

Study-related care, including the device implantation and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase Not Applicable

Age: 22Years +

All Genders

ID05508360

Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy LOPAIN2

Led by Spinal Stabilization Technologies · Updated on 2026-05-27

Participants Needed

Research Sites

156 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the PerQdisc Nucleus Replacement System in patients with degenerative disc disease DDD affecting one or more lumbar discs. This prospective, open-label, multi-center study aims to collect additional safety and effectiveness data for this minimally invasive device. The PerQdisc is designed to replace the nucleus pulposus in lumbar discs between L1 and S1, offering an alternative to spinal fusion surgery by aiming to preserve disc height and maintain spinal motion to reduce chronic low back pain. The study involves surgical implantation of the PerQdisc device using standard anterior, lateral, or minimally invasive posterolateral approaches. All patients who meet inclusion criteria and have no exclusions will be considered for nucleus replacement surgery following review by a Medical Advisory Board. The device replaces the disc nucleus at a single level of the lumbar spine, intending to preserve spinal movement and reduce pain. Participants will be monitored for safety and performance outcomes over time, including pain and disability scores at 6 and 12 months. Researchers will assess device expulsion, failure, revision surgeries, disc height, range of motion, neurological status, analgesic use, and serious adverse events up to 5 years after surgery. The study includes clinical evaluations, imaging, and questionnaires to track progress and safety, with total follow-up extending to 5 years post-implantation.

CONDITIONS

Brief Title

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

Who Can Participate

Age: 22Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patient is skeletally mature aged 22-70.
Patient has Degenerative Disc Disease at one or more levels between L1 and S1 with pain limited to a single level.
Patient has adequate disc height of at least 6 mm at the treated level.
Patient has undergone at least 6 months of conservative back treatment such as physical therapy or medications.
Patient has a preoperative Oswestry Disability Index score of 40 or higher out of 100.
Patient has a low back pain Visual Analog Scale score of 40 mm or higher.
Patient has signed the approved informed consent form.
All surgeries must be approved by the Medical Advisory Board.

You will not qualify if you...

Patient has less than 6 mm of disc height.
Patient has had prior lumbar spine surgery (except nucleoplasty at non-index levels).
Patient has had lumbar or thoracic spinal fusion; cervical fusion allowed if no lower extremity neurological deficits.
Patient has spondyloarthropathy or spondylolisthesis greater than 2 mm.
Patient has moderate or severe spinal stenosis or epidural lipomatosis.
Patient has significant facet disease as defined by pain improvement criteria.
Patient has any known active malignancy.
Patient is on or has had immunosuppressive therapy (steroids for inflammation allowed).
Patient has active or systemic infection.
Patient has autoimmune diseases including hepatitis, rheumatoid arthritis, lupus, AIDS, ARC, or HIV.
Patient has diabetes requiring daily insulin.
Patient has osteopenia of the spine (T-score -1.0 or lower).
Patient has morbid obesity defined as BMI over 40 or weight over 45 kg above ideal.
Patient has allergy to silicone or barium sulfate.
Patient has significant disc herniation or Schmorl's node at the treated level.
Patient shows less than 3 degrees motion on preoperative flexion/extension X-rays.
Patient belongs to a vulnerable population or cannot provide informed consent or comply with study requirements.
Intraoperative exclusions include imaging balloon protrusion beyond vertebra margin, violated endplates, narrow disc space, poor visualization, or nerve irritation during procedure.

Research Team

Maren Lange

Molly Bond

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