Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Implante artificial PerQdisc inserido cirurgicamente na lombar após nuclectomia 3 (LOPAIN3)

4 de novembro de 2026 atualizado por: Spinal Stabilization Technologies

Primeiro plano de investigação clínica em humanos Implante artificial PerQdisc lombar inserido cirurgicamente após nuclectomia "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.

Visão geral do estudo

Status

Suspenso

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

50

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

21 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Safety: Number of Patients with Serious Adverse Events related to the PerQdisc
Prazo: 12 months

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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Performance: ODI
Prazo: 3 months

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Exploratory Endpoint: Disch Height
Prazo: 3 months

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

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

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

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Spinal Stabilization Technologies

Colaboradores

Raylytic GmbH

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

16 de junho de 2023

Conclusão Primária (Estimado)

16 de setembro de 2027

Conclusão do estudo (Estimado)

16 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

30 de janeiro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de fevereiro de 2023

Primeira postagem (Real)

17 de fevereiro de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • DPQ114.B: LOPAIN3

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever