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Lumbaal operatief ingebracht kunstmatig PerQdisc-implantaat na nuclectomie 3 (LOPAIN3)

4 november 2026 bijgewerkt door: Spinal Stabilization Technologies

Klinisch onderzoeksplan als eerste in proef bij mensen Lumbaal operatief ingebracht kunstmatig PerQdisc-implantaat na nuclectomie "LOPAIN3"

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.

Studie Overzicht

Toestand

Geschorst

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The PerQdisc® Nucleus Replacement System is comprised of an in situ formed silicone-based prosthesis with its delivery system, implant fill device, dispenser gun, a disc access system and two different imaging balloons. For this trial, the PerQdisc® will be implanted using minimally invasive posterolateral (MIPL) approach. The implanted device provides an effective means of replacing dysfunctional nucleus pulposus while supporting the native annulus fibrosis to bridge annular defects.

Patients that suffer clinically significant lumbar disc herniations currently undergo discectomy procedures to relieve nerve root compression. The standard discectomy procedure does not correct the annular defect associated with the herniation and is associated with a risk for re-herniation. In addition, the progressive loss of disc height and overall lack of disc turgor and weight bearing capacity is thought to be associated with downstream degenerative changes that may lead to chronic low back pain and premature spondylosis.

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Oezbekistan
    • Tashkent
      • Tashkent, Tashkent, Oezbekistan, 100007
        • Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova
  • Paraguay
      • Asunción, Paraguay, 1101
        • Sanatorio Americano

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 osteopenia of the spine (T-score of -1.0 or lower). All patients 50 years of age or older, and any post menopausal women with a history of fractures should have a dual x-ray absorptiometry (DEXA) scan to confirm exclusion.
  • 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).
  • Patient has a significant Schmorl's node at the level to be treated, or any Schmorl's nodes affecting 3 or more lumbar levels. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes).
  • Patient has more than 20 degrees of mobility on flexion/extension radiographs at the index level
  • Patient has more than 10 degrees of lumbar scoliosis.
  • 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)
  • Patient is pregnant or plans to become pregnant during the course of the study. Pregnancy ruled out by serum HCG. If patient becomes pregnant during the course of the study and wishes to continue study participation, a new Pregnancy Informed Consent must be completed.

Intraoperative Exclusion:

  • Poor radiological visualization of Kambin's triangle
  • Patient has annular defect following surgical treatment of the disc herniation/protrusion that is greater than 6 mm
  • 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 of repositioning instruments.
  • Protrusion of the 50A 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Lumbar Disc Nucleus Replacement following discectomy

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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Safety: Number of Patients with Serious Adverse Events related to the PerQdisc
Tijdsspanne: 12 months

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Performance: ODI
Tijdsspanne: 3 months

Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
3 months
Performance: ODI
Tijdsspanne: 6 months

Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
6 months
Performance: ODI
Tijdsspanne: 12 months

Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
12 months
Performance: ODI
Tijdsspanne: 24 months

Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
24 months
Performance: VAS Back
Tijdsspanne: 3 months

Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
3 months
Performance: VAS Back
Tijdsspanne: 6 months

Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
6 months
Performance: VAS Back
Tijdsspanne: 12 months

Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
12 months
Performance: VAS Back
Tijdsspanne: 24 months

Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
24 months
Performance: VAS Leg
Tijdsspanne: 3 months

Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
3 months
Performance: VAS Leg
Tijdsspanne: 6 months

Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
6 months
Performance: VAS Leg
Tijdsspanne: 12 months

Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
12 months
Performance: VAS Leg
Tijdsspanne: 24 months

Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
24 months
Performance: Analgesic Score
Tijdsspanne: 3 months

Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
3 months
Performance: Analgesic Score
Tijdsspanne: 6 months

Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
6 months
Performance: Analgesic Score
Tijdsspanne: 12 months

Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
12 months
Performance: Analgesic Score
Tijdsspanne: 24 months

Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
24 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Tijdsspanne: 3 months

Freedom from reherniation/recurrent disc herniation
3 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Tijdsspanne: 6 months

Freedom from reherniation/recurrent disc herniation
6 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Tijdsspanne: 12 months

Freedom from reherniation/recurrent disc herniation
12 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Tijdsspanne: 24 months

Freedom from reherniation/recurrent disc herniation
24 months
Safety: Number of Patient that Received Supplemental fixation
Tijdsspanne: 3 months

Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
3 months
Safety: Number of Patient that Received Supplemental fixation
Tijdsspanne: 6 months

Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
6 months
Safety: Number of Patient that Received Supplemental fixation
Tijdsspanne: 12 months

Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
12 months
Safety: Number of Patient that Received Supplemental fixation
Tijdsspanne: 24 months

Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
24 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Exploratory Endpoint: Disch Height
Tijdsspanne: 3 months

Disc height in millimeters at each clinical visit as measured on plain film X-ray
3 months
Exploratory Endpoint: Disch Height
Tijdsspanne: 6 months

Disc height in millimeters at each clinical visit as measured on plain film X-ray
6 months
Exploratory Endpoint: Disch Height
Tijdsspanne: 12 months

Disc height in millimeters at each clinical visit as measured on plain film X-ray
12 months
Exploratory Endpoint: Disch Height
Tijdsspanne: 24 months

Disc height in millimeters at each clinical visit as measured on plain film X-ray
24 months
Exploratory Endpoint: RoM
Tijdsspanne: 3 months

Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs
3 months
Exploratory Endpoint: RoM
Tijdsspanne: 6 months

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
Exploratory Endpoint: RoM
Tijdsspanne: 12 months

Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs
12 months
Exploratory Endpoint: RoM
Tijdsspanne: 24 months

Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs
24 months
Exploratory Endpoint: Neurological Status
Tijdsspanne: 3 months

Maintenance and/or improvement 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
3 months
Exploratory Endpoint: Neurological Status
Tijdsspanne: 6 months

Maintenance and/or improvement 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
Exploratory Endpoint: Neurological Status
Tijdsspanne: 12 months

Maintenance and/or improvement 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
12 months
Exploratory Endpoint: Neurological Status
Tijdsspanne: 24 months

Maintenance and/or improvement 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
24 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Spinal Stabilization Technologies

Medewerkers

Raylytic GmbH

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 juni 2023

Primaire voltooiing (Geschat)

16 september 2027

Studie voltooiing (Geschat)

16 juni 2028

Studieregistratiedata

Eerst ingediend

30 januari 2023

Eerst ingediend dat voldeed aan de QC-criteria

7 februari 2023

Eerst geplaatst (Werkelijk)

17 februari 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

4 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DPQ114.B: LOPAIN3

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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