Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3

NCT05732818 | Suspended DMC

• 1 other identifier: DPQ114.B: LOPAIN3
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

Brief Summary

This study is a First in Human, prospective, multi-center clinical study intended to collect safety and performance information for the Spinal Stabilization Technologies PerQdisc® Nucleus Replacement System and procedure concurrently following a successful discectomy using a minimally invasive posterolateral (MIPL) approach. Patients that are at least 21 years or older, presenting with symptomatic radiculopathy from a focal lumbar disc herniation that requires surgical decompression will be included in this study.

Conditions

Radiculopathy; Back Pain; Disc Herniation; Herniated Nucleus Pulposus; Herniated Disc; Disc Injury; Disk Herniated Lumbar; Back Pain With Radiation

Outcome Measures

Primary Outcomes (1)

• Safety: Number of Patients with Serious Adverse Events related to the PerQdisc

  Freedom from device- and procedure-related serious adverse events definitely related to the PerQdisc Device or the PerQdisc Surgical Procedure

  12 months

Secondary Outcomes (24)

• Performance: ODI

  3 months

• Performance: ODI

  6 months

• Performance: ODI

  12 months

• Performance: ODI

  24 months

• Performance: VAS Back

  3 months

Other Outcomes (12)

• Exploratory Endpoint: Disch Height

  3 months

• Exploratory Endpoint: Disch Height

  6 months

• Exploratory Endpoint: Disch Height

  12 months

Study Arms (1)

Lumbar Disc Nucleus Replacement following discectomy

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 following discectomy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is skeletally mature and at least 21 years of age.
• Patient has a lumbar disc herniation, between L1-S1, with compressive radiculopathy of the traversing nerve root requiring partial discectomy or sequestrectomy. Only one lumbar disc may be treated with the PerQdisc device.
• Patient must have an overall disc herniation (extrusion or protrusion) such that half or less of the width of the dorsal annulus of the spinal canal, is affected by the herniation. The width of the canal is defined by the lateral recesses and the central canal (i.e. pedicle to pedicle).
• Patient must have a minimum of 6 mm of disc height as measured in the center of the affected disc.
• Patient is willing and able to give informed consent.
• All surgeries must be approved by at least 2 members of the Medical Advisory Board (MAB) - potential anatomical limitations of safely accessing Kambin's, extent of annular disruption, as well as overall patient criteria will be evaluated

You may not qualify if:

• Patient has had prior lumbar spine surgery at the index level (nucleoplasy is acceptable).
• Patient has had spinal fusion in the lumbar spine. Cervical or thoracic fusion is allowed as long as there are no neurologic deficits in the lower extremities.
• Patient has spondyloarthropathy or other spondylolisthesis greater than 4 mm or spondylolysis at the index level (on standing X-ray).
• Patient has underlying moderate or severe spinal stenosis (congenital, degenerative, or due to epidural lipomatosis) at any level. If the index level shows stenosis due to the disc herniation, it is acceptable if the index level is going to be treated concurrently with the PerQdsic procedure.
• Patient has compressive radiculopathy of the exiting nerve root at the index level.
• Patient has significant facet disease. Significant is defined as clinically confirmed by diagnostic block or radiologically grade 2 or higher (mild joint narrowing and irregularity are acceptable, but not sclerosis or osteophyte formation).
• 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 local or systemic infection.
• Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including AIDS, AIDS related complex (ARC) and HIV.
• Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management.
• Patient has morbid obesity defined as a body mass index (BMI) more than 35 (\>35).
• Patient has a known allergy to silicone or barium sulfate.
• Patient has a broad disc herniation that is wider than ½ of the dorsal annulus forming the wall of the spinal canal
• Patient requires decompression involving disruption of the midline bony-ligamentous elements (i.e. laminectomy).

Sponsors & Collaborators

• Raylytic GmbH: collaborator
• Spinal Stabilization Technologies: lead

Study Sites (2)

Sanatorio Americano

Asunción, 1101, Paraguay

Location

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

Tashkent, Tashkent, 100007, Uzbekistan

Location

MeSH Terms

Conditions

Back Pain; Radiculopathy; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

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: 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: January 30, 2023
• First Posted: February 17, 2023
• Study Start: June 16, 2023
• Primary Completion (Estimated): September 16, 2026
• Study Completion (Estimated): June 16, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

UZ (1); PA (1)