Clinical trial NCT05508360: "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
Official title: "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Degenerative Disc Disease
Chronic Low-back Pain
Keywords: Degenerative Disc Disease
DDD
Chronic Low Back Pain
cLBP
Disc Herniation
Nucleus Replacement
Low Back Pain
Lead sponsor: Spinal Stabilization Technologies
Sponsor class: INDUSTRY
First posted: 2022-08-19
Enrollment: 72
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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).
Primary purpose: TREATMENT

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 any standard anterior, standard lateral, or minimally invasive posterolateral surgical 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.

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.

Primary outcomes:
measure: Perfromance: ODI
timeFrame: 6 months
measure: Perfromance: ODI
timeFrame: 12 months
measure: Performance: VAS
timeFrame: 6 months
measure: Performance: VAS
timeFrame: 12 months
measure: Safety: Expulsion & Device Failure
timeFrame: 6 months
measure: Safety: Expulsion & Device Failure
timeFrame: 12 months
Secondary outcomes:
measure: Safety: Revision Surgery
timeFrame: 6 months, 12 months, and 5 years
measure: Safety: Expulsion & Device Failure
timeFrame: 5 years
measure: Performance: Disc Height
timeFrame: 6 months, 12 months, and 5 years
measure: Performance: RoM
timeFrame: 6 months, 12 months, 5 years
measure: Safety: Neurological Status
timeFrame: 6 months, 12 months, and 5 years
measure: Performance: Analgesic Score
timeFrame: 6 months, 12 months, and 5 years
measure: Safety: SAE
timeFrame: 6 months, 12 months, and 5 years
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: CIGE: Centro de Imunologia y Genetica
state: Antioquia
city: Medellín
country: Colombia
facility: Fundacion Hospitalaria San Vicente de Paul
state: Antioquia
city: Barranquilla
country: Colombia
facility: Cediul S.A.
state: Atlantico
city: Barranquilla
country: Colombia
facility: Fundación Campbell
state: Atlantico
city: Barranquilla
country: Colombia
facility: Sabbag Radiólogos S.A.
state: Atlantico
city: Bogotá
country: Colombia
facility: Sociedad de Cirugia de Bogota- Hospital de San Jose
state: D.c.
city: Cali
country: Colombia
facility: Clínica Imbanaco de Cali S.A.
state: Valle del Cauca
city: Panama
country: Panama
facility: Pacífica Salud Hospital Punta Pacífica
city: Asunción
country: Paraguay
facility: Sanatario Americano
city: Tashkent
country: Uzbekistan
facility: Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova
Study officials:
affiliation: Jewish General Hospital
name: Jeff Golan, MD
role: STUDY_CHAIR
affiliation: London Spine Clinic/ATOS-Klinik
name: Michael Hess, MD
role: STUDY_CHAIR
References: