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

Launched by SPINAL STABILIZATION TECHNOLOGIES · Aug 17, 2022

Keywords

ClinConnect Summary

The LOPAIN2 clinical trial is investigating a new treatment option for patients suffering from chronic low back pain caused by Degenerative Disc Disease (DDD). This study will involve 72 participants and aims to gather more information about the safety and effectiveness of the PerQdisc Nucleus Replacement System, an artificial implant designed to help stabilize the spine after a certain type of back surgery called nucleotomy.

To join the trial, participants need to be at least 21 years old, have DDD affecting one specific disc level between the lower back vertebrae L1 and S1, and not have responded to non-surgical treatments for their pain. Participants will undergo the procedure at one of the study sites, and they will be closely monitored for their safety and how well the treatment works. It’s important to note that not everyone will qualify; certain health conditions, previous surgeries, and other factors may exclude potential participants. This trial is currently recruiting, so if you or someone you know might be interested, it could be a great opportunity to explore a new treatment for back pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient is skeletally mature aged 22-70.
• • Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but the discogenic pain must be limited to a single level.
• • Patient has adequate disc height (6mm) at the level to be treated
• • Patient has exhausted a minimum of 6 months of conservative treatment for their back (e.g. physical therapy, medications, injections, life style changes, etc).
• • Patient has a preoperative Oswestry Disability questionnaire score ≥ 40 out of 100 points (40/100)
• • Patient has a low back pain Visual Analog Scale (VAS) ≥ 40 mm (4 cm)
• • Patient has signed the approved Informed Consent Form.
• • All surgeries must be approved by the Medical Advisory Board (MAB)
• Exclusion Criteria:
• • Patient has less than 6 mm of disc height.
• • Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable).
• • Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits in the lower extremities.
• • Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.
• • Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
• • Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target level according to SIS guidelines (diagnostic, contrast controlled).
• • 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 or local systemic infection.
• • Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including AIDS, 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). A DEXA scan should be performed to rule out patients considered at risk for osteopenia.
• • Patient has morbid obesity defined as a body mass index (BMI) more than 40 or a weight of more than 45 kg (100 lbs.) over ideal body weight.
• • Patient has a known allergy to silicone or barium sulfate.
• • Patient has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion.
• • Patient has a significant Schmorl's node in the level to be treated. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes).
• • Patient has motion of less than 3 degrees on pre-operative lateral flexion/extension radiographs.
• • 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)
• Intraoperative Exclusion Criteria:
• • Protrusion of the 20A 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.
• • Patient has a disc space that is too narrow for implantation. MIPL Specific
• • Poor radiological visualization of Kambin's triangle.
• • 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 or repositioning instruments.