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History of Changes for Study: NCT05508360
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) (LOPAIN2)
Latest version (submitted February 9, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 17, 2022 None (earliest Version on record)
2 January 27, 2023 Study Status and Contacts/Locations
3 February 9, 2023 Contacts/Locations and Study Status
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Study NCT05508360
Submitted Date:  August 17, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: LOPAIN2
Brief Title: "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) (LOPAIN2)
Official Title: "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2022
Overall Status: Recruiting
Study Start: August 22, 2022
Primary Completion: August 22, 2024 [Anticipated]
Study Completion: August 22, 2029 [Anticipated]
First Submitted: August 1, 2022
First Submitted that
Met QC Criteria:
August 17, 2022
First Posted: August 19, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
August 17, 2022
Last Update Posted: August 19, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Spinal Stabilization Technologies
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
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
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
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).
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 72 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
2. 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
3. Performance: VAS
[ Time Frame: 6 months ]

Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)
4. Performance: VAS
[ Time Frame: 12 months ]

Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)
5. 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
6. 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
Secondary Outcome Measures:
1. Safety: Revision Surgery
[ Time Frame: 6 months, 12 months, and 5 years ]

Incidence of revision surgery
2. 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
3. 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
4. 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
5. 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
6. 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)
7. 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
Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Andy Murillo
Telephone: 1 (210) 632-5444
Email: amurillo@sstspine.com
Central Contact Backup: Molly Bond
Telephone: 1 (715) 577-7527
Email: mbond@sstspine.com
Study Officials: Jeff Golan, MD
Study Chair
Jewish General Hospital
Michael Hess, MD
Study Chair
London Spine Clinic/ATOS-Klinik
Locations: Colombia, Antioquia
Fundacion Hospitalaria San Vicente de Paul
[Not yet recruiting]
Medellín, Antioquia, Colombia
Contact:Contact: Alejandra Mazo alejandra.mazo@sanvicentsfundacion.com
Contact:Principal Investigator: Eloy Barrios, MD
Colombia, Atlantico
Cediul S.A.
[Recruiting]
Barranquilla, Atlantico, Colombia
Contact:Contact: Yolanda Muvdi eclinicos2@cediul.com
Contact:Principal Investigator: Salvador Mattar, MD
Fundación Campbell
[Recruiting]
Barranquilla, Atlantico, Colombia
Contact:Contact: Briany Angulo investigacion@clinicacampbell.com
Contact:Principal Investigator: Jose Dangond, MD
Sabbag Radiólogos S.A.
[Not yet recruiting]
Barranquilla, Atlantico, Colombia
Contact:Contact: Diana Rodriguez coordinatorinvestigacion@sabbagradiologos.com
Contact:Principal Investigator: Nestor Taboada, MD
Colombia, D.c.
Sociedad de Cirugia de Bogota- Hospital de San Jose
[Not yet recruiting]
Bogotá, D.c., Colombia
Contact:Contact: Laura Alvarado Coordinacionestudios@hospitalsanjose.org
Contact:Principal Investigator: Rodolfo Paez, MD
Colombia, Valle Del Cauca
Clínica Imbanaco de Cali S.A.
[Recruiting]
Cali, Valle Del Cauca, Colombia
Contact:Contact: Monica Dominguez monica.dominguez@imbanaco.com
Contact:Principal Investigator: Eduardo Walteros, MD
Paraguay
Sanatarion Americano
[Recruiting]
Asunción, Paraguay, 1101
Contact:Contact: Carlos Cetraro radiosolutionspy@gmail.com
Contact:Principal Investigator: Francisco Duarte, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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