Implanting a new artificial disc after lumbar discectomy
Clinical Investigation Plan First in Human Trial Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy "LOPAIN3"
This study is testing a new artificial disc to see if it can help people over 21 with back pain from a herniated disc feel better after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Spinal Stabilization Technologies Industry-sponsored |
| Locations | 3 sites (Tbilisi and 2 other locations) |
| Trial ID | NCT05732818 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and performance of the PerQdisc® Nucleus Replacement System, which is designed to replace the dysfunctional nucleus pulposus following a minimally invasive discectomy. The study involves patients aged 21 and older who experience symptomatic radiculopathy due to lumbar disc herniation. The trial aims to assess how effectively the implant can support the annulus fibrosis and prevent re-herniation, while also addressing the loss of disc height and associated degenerative changes. The procedure utilizes a specialized delivery system and imaging balloons to ensure precise implantation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with symptomatic radiculopathy from a lumbar disc herniation requiring surgical intervention.
Not a fit: Patients with multiple lumbar disc herniations or those who do not meet the specific anatomical and health criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of re-herniation and chronic back pain for patients undergoing lumbar discectomy.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using artificial implants for disc replacement, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is skeletally mature and at least 21 years of age. * Patient has a lumbar disc herniation, between L1-S1, with compressive radiculopathy of the traversing nerve root requiring partial discectomy or sequestrectomy. Only one lumbar disc may be treated with the PerQdisc device. * Patient must have an overall disc herniation (extrusion or protrusion) such that half or less of the width of the dorsal annulus of the spinal canal, is affected by the herniation. The width of the canal is defined by the lateral recesses and the central canal (i.e. pedicle to pedicle). * Patient must have a minimum of 6 mm of disc height as measured in the center of the affected disc. * Patient is willing and able to give informed consent. * All surgeries must be approved by at least 2 members of the Medical Advisory Board (MAB) - potential anatomical limitations of safely accessing Kambin's, extent of annular disruption, as well as overall patient criteria will be evaluated Exclusion Criteria: * Patient has had prior lumbar spine surgery at the index level (nucleoplasy is acceptable). * Patient has had spinal fusion in the lumbar spine. Cervical or thoracic fusion is allowed as long as there are no neurologic deficits in the lower extremities. * Patient has spondyloarthropathy or other spondylolisthesis greater than 4 mm or spondylolysis at the index level (on standing X-ray). * Patient has underlying moderate or severe spinal stenosis (congenital, degenerative, or due to epidural lipomatosis) at any level. If the index level shows stenosis due to the disc herniation, it is acceptable if the index level is going to be treated concurrently with the PerQdsic procedure. * Patient has compressive radiculopathy of the exiting nerve root at the index level. * Patient has significant facet disease. Significant is defined as clinically confirmed by diagnostic block or radiologically grade 2 or higher (mild joint narrowing and irregularity are acceptable, but not sclerosis or osteophyte formation). * Patient has any known active malignancy. * Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed. * Patient has active local or systemic infection. * Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including AIDS, AIDS related complex (ARC) and HIV. * Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management. * Patient has osteopenia of the spine (T-score of -1.0 or lower). All patients 50 years of age or older, and any post menopausal women with a history of fractures should have a dual x-ray absorptiometry (DEXA) scan to confirm exclusion. * Patient has morbid obesity defined as a body mass index (BMI) more than 35 (\>35). * Patient has a known allergy to silicone or barium sulfate. * Patient has a broad disc herniation that is wider than ½ of the dorsal annulus forming the wall of the spinal canal * Patient requires decompression involving disruption of the midline bony-ligamentous elements (i.e. laminectomy). * Patient has a significant Schmorl's node at the level to be treated, or any Schmorl's nodes affecting 3 or more lumbar levels. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes). * Patient has more than 20 degrees of mobility on flexion/extension radiographs at the index level * Patient has more than 10 degrees of lumbar scoliosis. * Patient 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) * Patient is pregnant or plans to become pregnant during the course of the study. Pregnancy ruled out by serum HCG. If patient becomes pregnant during the course of the study and wishes to continue study participation, a new Pregnancy Informed Consent must be completed. Intraoperative Exclusion: * Poor radiological visualization of Kambin's triangle * Patient has annular defect following surgical treatment of the disc herniation/protrusion that is greater than 6 mm * Sustained irritation of the exiting nerve root during any aspect of the annular dilation technique (leg movement or if performing with electrical monitoring) in spite of repositioning instruments. * Protrusion of the 50A Imaging Balloon up to or beyond the outer margin of the vertebra during the imaging steps. * Patient has a violated endplate as determined by imaging balloons during fluoroscopy.
Where this trial is running
Tbilisi and 2 other locations
- St. John the Merciful Private Clinic — Tbilisi, Georgia (Withdrawn)
- Sanatorio Americano — Asunción, Paraguay (Recruiting)
- Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova — Tashkent, Uzbekistan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.