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).
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Echo Cundiff, Director of Clinical Research
- Номер телефона: 815-848-4189
- Электронная почта: ecundiff@spinalsimplicity.com
Места учебы
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Calgary, Канада
- Beam Radiology
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Контакт:
- Kimberly Clinical Research Manager
- Номер телефона: 587-885-2988
- Электронная почта: kcarcary@beamradiology.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Treatment
Intralink Device |
Device: Intralink
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Oswestry Disability Index (ODI)
Временное ограничение: 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.
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Evaluate type of adverse events
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CANLINK-2026-CIP
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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