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

Degenerative Disc Disease Clinical Trial

— LOPAIN2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05508360
• Other study ID #: LOPAIN2
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: August 22, 2029

Study information

• Verified date: February 2023
• Source: Spinal Stabilization Technologies
• Contact: Andy Murillo
• Phone: 1 (210) 632-5444
• Email: amurillo[@]sstspine.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: August 22, 2029
• Est. primary completion date: August 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• 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.

Locations

Country	Name	City	State
Colombia	Cediul S.A.	Barranquilla	Atlantico
Colombia	Fundación Campbell	Barranquilla	Atlantico
Colombia	Sabbag Radiólogos S.A.	Barranquilla	Atlantico
Colombia	Sociedad de Cirugia de Bogota- Hospital de San Jose	Bogotá	D.c.
Colombia	Clínica Imbanaco de Cali S.A.	Cali	Valle Del Cauca
Colombia	CIGE: Centro de Imunologia y Genetica	Medellín	Antioquia
Colombia	Fundacion Hospitalaria San Vicente de Paul	Medellín	Antioquia
Paraguay	Sanatario Americano	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
Spinal Stabilization Technologies

Countries where clinical trial is conducted

Colombia,  Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfromance: ODI	Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool	6 months
Primary	Perfromance: ODI	Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool	12 months
Primary	Performance: VAS	Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)	6 months
Primary	Performance: VAS	Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)	12 months
Primary	Safety: Expulsion & Device Failure	Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's	6 months
Primary	Safety: Expulsion & Device Failure	Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's	12 months
Secondary	Safety: Revision Surgery	Incidence of revision surgery	6 months, 12 months, and 5 years
Secondary	Safety: Expulsion & Device Failure	Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's	5 years
Secondary	Performance: Disc Height	Preservation of intervertebral disc height (in mm) as measured on MRI post-surgery compared to baseline	6 months, 12 months, and 5 years
Secondary	Performance: RoM	Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs	6 months, 12 months, 5 years
Secondary	Safety: Neurological Status	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	6 months, 12 months, and 5 years
Secondary	Performance: Analgesic Score	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)	6 months, 12 months, and 5 years
Secondary	Safety: SAE	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	6 months, 12 months, and 5 years