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

NCT05508360 | Recruiting DMC

• 1 other identifier: LOPAIN2
• Study Type: interventional
• Target: 72
• Locations: 3 countries
• Sites: 9

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.

Conditions

Chronic Low-back Pain; Degenerative Disc Disease

Keywords

Degenerative Disc Disease; DDD; Chronic Low Back Pain; cLBP; Disc Herniation; Nucleus Replacement; Low Back Pain

Outcome Measures

Primary Outcomes (6)

• Perfromance: ODI

  Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool

  6 months

• Perfromance: ODI

  Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool

  12 months

• Performance: VAS

  Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)

  6 months

• Performance: VAS

  Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)

  12 months

• Safety: Expulsion & Device Failure

  Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's

  6 months

• 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 Outcomes (7)

• Safety: Revision Surgery

  6 months, 12 months, and 5 years

• Safety: Expulsion & Device Failure

  5 years

• Performance: Disc Height

  6 months, 12 months, and 5 years

• Performance: RoM

  6 months, 12 months, 5 years

• Safety: Neurological Status

  6 months, 12 months, and 5 years

Study Arms (1)

Lumbar Disc Nucleus Replacement

EXPERIMENTAL

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

Interventions

PerQdisc Nucleus Replacement System DEVICE

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.

Lumbar Disc Nucleus Replacement

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spinal Stabilization Technologies: lead

Study Sites (10)

CIGE: Centro de Imunologia y Genetica

Medellín, Antioquia, Colombia

ACTIVE NOT RECRUITING

Fundacion Hospitalaria San Vicente de Paul

Medellín, Antioquia, Colombia

ACTIVE NOT RECRUITING

Cediul S.A.

Barranquilla, Atlántico, Colombia

ACTIVE NOT RECRUITING

Fundación Campbell

Barranquilla, Atlántico, Colombia

WITHDRAWN

Sabbag Radiólogos S.A.

Barranquilla, Atlántico, Colombia

WITHDRAWN

Sociedad de Cirugia de Bogota- Hospital de San Jose

Bogotá, D.C., Colombia

ACTIVE NOT RECRUITING

Clínica Imbanaco de Cali S.A.

Cali, Valle del Cauca Department, Colombia

ACTIVE NOT RECRUITING

Pacífica Salud Hospital Punta Pacífica

Panama City, Provincia de Panamá, Panama

RECRUITING

Sanatario Americano

Asunción, 1101, Paraguay

RECRUITING

Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova

Tashkent, Uzbekistan

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Intervertebral Disc Displacement; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Michael Hess, MD

  London Spine Clinic/ATOS-Klinik

  STUDY CHAIR

Central Study Contacts

Maren Lange

CONTACT

8004841588; mlange@sstspine.com

Molly Bond

CONTACT

1 (715) 577-7527; mbond@sstspine.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 19, 2022
• Study Start: August 22, 2022
• Primary Completion (Estimated): August 22, 2027
• Study Completion (Estimated): August 22, 2030
• Last Updated: May 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1); UZ (1); CO (7)