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).
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Echo Cundiff, Director of Clinical Research
- 电话号码：815-848-4189
- 邮箱：ecundiff@spinalsimplicity.com
学习地点
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Calgary、加拿大
- Beam Radiology
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接触：
- Kimberly Clinical Research Manager
- 电话号码：587-885-2988
- 邮箱：kcarcary@beamradiology.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Treatment
Intralink Device |
Device: Intralink
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Oswestry Disability Index (ODI)
大体时间：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.
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluate type of adverse events
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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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合作者和调查者
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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