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

• ClinicalTrials.gov Identifier: NCT05508360
• Recruitment Status: Recruiting
• First Posted: August 19, 2022
• Last Update Posted: February 10, 2023
• Sponsor: Spinal Stabilization Technologies
• Information provided by (Responsible Party): Spinal Stabilization Technologies

Tracking Information

• First Submitted Date: August 1, 2022
• First Posted Date: August 19, 2022
• Last Update Posted Date: February 10, 2023
• Actual Study Start Date: August 22, 2022
• Estimated Primary Completion Date: August 22, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 17, 2022)

• Perfromance: ODI [ Time Frame: 6 months ]
  Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
• Perfromance: ODI [ Time Frame: 12 months ]
  Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
• Performance: VAS [ Time Frame: 6 months ]
  Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)
• Performance: VAS [ Time Frame: 12 months ]
  Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)
• Safety: Expulsion & Device Failure [ Time Frame: 6 months ]
  Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's
• Safety: Expulsion & Device Failure [ Time Frame: 12 months ]
  Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 17, 2022)

• Safety: Revision Surgery [ Time Frame: 6 months, 12 months, and 5 years ]
  Incidence of revision surgery
• Safety: Expulsion & Device Failure [ Time Frame: 5 years ]
  Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's
• Performance: Disc Height [ Time Frame: 6 months, 12 months, and 5 years ]
  Preservation of intervertebral disc height (in mm) as measured on MRI post-surgery compared to baseline
• Performance: RoM [ Time Frame: 6 months, 12 months, 5 years ]
  Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs
• Safety: Neurological Status [ Time Frame: 6 months, 12 months, and 5 years ]
  Maintenance of baseline neurologic status through physical assessment evaluating nerve compression at baseline and post-surgical follow-up using pain, motor strength, and sensation feedback from the patient on a 0 (no compression) to 5 (major compression) scale
• Performance: Analgesic Score [ Time Frame: 6 months, 12 months, and 5 years ]
  Change in level of pain medication used comparing baseline to follow up visits based on a medication scale ranging from 0 (no meds) - 4 (high dose opioids)
• Safety: SAE [ Time Frame: 6 months, 12 months, and 5 years ]
  Incidence of serious adverse events that are related to the surgical procedure or Incidence of Serious Adverse Events related to the surgical procedure or device

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
• Official Title: "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
• Brief Summary: This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.
• Detailed Description: This study will be a prospective, open-label, multi-center study that will collect additional safety and efficacy data for the minimally invasive PerQdisc Nucleus Replacement Device (NRD). Patients will have degenerative disc disease (DDD) in one or more lumbar discs. The NRD is used for surgical replacement of a single nucleus pulposus between spinal lumbar discs L1-S1 using an anterior or lateral transpsoas approach. Currently the surgical gold standard involves spinal fusion of the affected vertebral bodies, reducing range of motion and increasing stress on other vertebral bodies. The goal of nucleus replacement is to reduce chronic low back pain by maintaining disc height while preserving range of motion.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

This is an open-label study. Patients will receive one implant if they meet all inclusion/exclusion criteria after a review by the Medical Advisory Board (MAB).

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Degenerative Disc Disease
• Chronic Low-back Pain

Intervention

Device: PerQdisc Nucleus Replacement System

Lumbar spine disc nucleus replacement system. All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board.

Study Arms

Experimental: Lumbar Disc Nucleus Replacement

All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board.

Intervention: Device: PerQdisc Nucleus Replacement System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 17, 2022): 72
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 22, 2029
• Estimated Primary Completion Date: August 22, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patient is skeletally mature and at least 21 years of age.
• 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 is not responsive to conservative, non-surgical treatment for back pain.
• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Andy Murillo; 1 (210) 632-5444; amurillo@sstspine.com

Contact: Molly Bond; 1 (715) 577-7527; mbond@sstspine.com

• Listed Location Countries: Colombia, Paraguay

Administrative Information

• NCT Number: NCT05508360
• Other Study ID Numbers: LOPAIN2
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Spinal Stabilization Technologies
• Original Responsible Party: Same as current
• Current Study Sponsor: Spinal Stabilization Technologies
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Jeff Golan, MD; Jewish General Hospital
• Study Chair: Michael Hess, MD; London Spine Clinic/ATOS-Klinik

• PRS Account: Spinal Stabilization Technologies
• Verification Date: February 2023