CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
CANLINK: A Prospective Clinical Study Evaluating the Safety and Performance of the Intralink Intradiscal Device for Treatment of Low Back Pain From Degenerative Disc Disease
A single site, prospective study to evaluate the safety and performance of the Intralink device in participants with chronic or recurrent non-radicular discogenic low back pain (LBP) due to degenerative disc disease (DDD).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study designed to evaluate the safety and effectiveness of the Intralink device in participants with chronic or recurrent non-radicular discogenic LBP due to DDD.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Echo Cundiff, Director of Clinical Research
- Número de teléfono: 815-848-4189
- Correo electrónico: ecundiff@spinalsimplicity.com
Ubicaciones de estudio
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Calgary, Canadá
- Beam Radiology
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Contacto:
- Kimberly Clinical Research Manager
- Número de teléfono: 587-885-2988
- Correo electrónico: kcarcary@beamradiology.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 22 - 80 years
- Degenerative Disc Disease (DDD)
- Six (6) months or more of chronic low back pain and failure to respond to conservative care
- Pain medication use has been stable for at least 30 days
Exclusion Criteria:
- Body Mass Index (BMI) >40 kg/m2
- Uncontrolled diabetes
- Symptomatic DDD at more than 2 levels
- Previously diagnosed Paget's disease, osteomalacia, other metabolic bone disease
- Target disc collapse (disc height loss)
- Active systemic or spine infection
- Recent (< 3 months) therapeutic interventions (i.e., IDET, PRP or stem cell injections) on the target disc(s)
- Any surgery at the index level (i.e. discectomy or intradiscal ablation) or any extensive surgery (fusion, artificial disc, laminectomy) at any lumbar level
- Previous treatment of target disc level with steroid injection, intradiscal injection, trigger point injection, facet or medial branch block within 90 days of enrollment
- Active malignancy
- Spinal tumor
- Presence of extruded disc herniation or wide annular fissures confluent with large disc protrusions at the symptomatic level.
- Symptomatic spinal stenosis (i.e., neurogenic claudication)
- Congenital or degenerative spondylolisthesis greater than grade 1
- Currently participating in another investigational study that could interfere with the outcome measures of this study
- Known anaphylactic reaction to contrast dye
- Opioid medication >60 MME/day within 60 days of enrollment
- If female, participants who are pregnant or are trying to become pregnant during the course of the trial (due to risks of additional radiation exposures); participants of child-bearing potential that are sexually active must use a reliable form of birth control and present a negative urine pregnancy test prior to the implant procedure
- Other protocol defined inclusion/exclusion may apply
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Treatment
Intralink Device |
Device: Intralink
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Oswestry Disability Index (ODI)
Periodo de tiempo: 1 Month compared to Baseline
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Change from baseline in mean disability scores using Oswestry Disability Index (ODI) ODI is a self-reported questionnaire widely used to track changes in a patient's condition over time and evaluate the effectiveness of treatments for low back pain. The ODI consists of 10 sections, each addressing a specific aspect of daily functioning. A higher score indicates greater disability. The final score/index ranges from 0-100 scale. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed bound. |
1 Month compared to Baseline
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Assess occurrence of serious adverse events post-treatment.
Periodo de tiempo: Through 1 Month post procedure
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Frequency of serious adverse events post implant |
Through 1 Month post procedure
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluate type of adverse events
Periodo de tiempo: Baseline through 6 months post procedure
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Incidence and type of adverse events (AEs) and serious adverse events (SAEs) |
Baseline through 6 months post procedure
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Assess change from baseline in mean disability scores using Oswestry Disability Index (ODI) post-procedure
Periodo de tiempo: 3, 6, 12, and 24 months post procedure
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Change from baseline in mean disability scores using Oswestry Disability Index (ODI) ODI is a self-reported questionnaire widely used to track changes in a patient's condition over time and evaluate the effectiveness of treatments for low back pain. The ODI consists of 10 sections, each addressing a specific aspect of daily functioning. A higher score indicates greater disability. The final score/index ranges from 0-100 scale. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed bound. |
3, 6, 12, and 24 months post procedure
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Assess change from baseline in mean pain scores using Visual Analog Scale (VAS)
Periodo de tiempo: 1, 3, 5, 12, and 24 months post procedure
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Change from baseline in mean pain scores using Visual Analog Scale (VAS) The VAS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-100 mm scale, with zero meaning "no pain" and 100 meaning "the worst pain imaginable". |
1, 3, 5, 12, and 24 months post procedure
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Evaluate change of baseline spinal instability using flexion-extension radiographic imaging
Periodo de tiempo: Baseline, 1, 3, 5, 12, and 24 months
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Proportion of participants with a 50% or greater reduction from baseline value in spinal instability (when baseline value is greater than or equal to 1.0), as measured by vertebral angular motion and sagittal plane translations on flexion-extension radiographs |
Baseline, 1, 3, 5, 12, and 24 months
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Assess use of escalated interventions post-procedure
Periodo de tiempo: From Baseline to 1, 3, 6, 12, and 24 months
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Any of the following count as escalated interventions: increase pain medication use and additional interventions - i.e. injections and surgical interventions at the treatment level. |
From Baseline to 1, 3, 6, 12, and 24 months
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Patient Global Impression of Change (PGIC)
Periodo de tiempo: 1, 3, 6, 12, and 24 months post-implant
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The Patient Global Impression of Change (PGIC) PGIC is a standardized tool designed to assess a patient's self-reported perception of improvement or worsening in their health status over time. The PGIC consists of 1 question, using a 1 to 7 scale: 1-Very Much Improved to 7-Very much Worse. |
1, 3, 6, 12, and 24 months post-implant
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Patient Satisfaction
Periodo de tiempo: 1, 3, 6, 12, and 24 months post-implant
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Patient Satisfaction Survey is designed to assess a patient's self-reported satisfaction or dissatisfaction on a 5 point scale. 1- Very Satisfied to 5-Very Dissatisfied |
1, 3, 6, 12, and 24 months post-implant
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Hedman T, Yu J, Singh H, Deer T. Early Clinical Results of Intervertebral Joint Stabilization by Injectable Load-Sharing Polymers. J Pain Res. 2023 Aug 10;16:2777-2789. doi: 10.2147/JPR.S413104. eCollection 2023.
- Hedman T, Rogers A. Pathomechanics of Early-Stage Lumbar Intervertebral Disc Degradation Leading to Discogenic Pain-A Narrative Review. Bioengineering (Basel). 2025 Apr 5;12(4):389. doi: 10.3390/bioengineering12040389.
- Hedman T, Rogers A, Beall D. A Self-Polymerizing Mesh of Nano-Tethers for the Mechanical Constraint of Degraded Intervertebral Discs-A Review of 25 Years of Pre-Clinical and Early Clinical Research. Bioengineering (Basel). 2024 May 24;11(6):535. doi: 10.3390/bioengineering11060535.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CANLINK-2026-CIP
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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