Actively Recruiting
Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy (LOPAIN2)
Led by Spinal Stabilization Technologies · Updated on 2026-05-27
72
Participants Needed
10
Research Sites
156 weeks
Total Duration
On this page
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
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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgical replacement of a single lumbar disc nucleus using the PerQdisc Nucleus Replacement Device.
1 surgical visit (in-person)
Duration - Up to 5 years
Participants are monitored for safety and efficacy outcomes including device performance, neurological status, and pain scores.
Multiple follow-up visits over 5 years
Trial Site Locations
Total: 10 locations
1
CIGE: Centro de Imunologia y Genetica
Medellín, Antioquia, Colombia
Active, Not Recruiting
2
Fundacion Hospitalaria San Vicente de Paul
Medellín, Antioquia, Colombia
Active, Not Recruiting
3
Cediul S.A.
Barranquilla, Atlántico, Colombia
Active, Not Recruiting
4
Fundación Campbell
Barranquilla, Atlántico, Colombia
Withdrawn
5
Sabbag Radiólogos S.A.
Barranquilla, Atlántico, Colombia
Withdrawn
6
Sociedad de Cirugia de Bogota- Hospital de San Jose
Bogotá, D.C., Colombia
Active, Not Recruiting
7
Clínica Imbanaco de Cali S.A.
Cali, Valle del Cauca Department, Colombia
Active, Not Recruiting
8
Pacífica Salud Hospital Punta Pacífica
Panama City, Provincia de Panamá, Panama
Actively Recruiting
9
Sanatario Americano
Asunción, Paraguay, 1101
Actively Recruiting
10
Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova
Tashkent, Uzbekistan
Actively Recruiting
Research Team
M
Maren Lange
M
Molly Bond
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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