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).
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Echo Cundiff, Director of Clinical Research
- 電話番号：815-848-4189
- メール：ecundiff@spinalsimplicity.com
研究場所
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Calgary、カナダ
- Beam Radiology
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コンタクト：
- Kimberly Clinical Research Manager
- 電話番号：587-885-2988
- メール：kcarcary@beamradiology.com
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Treatment
Intralink Device |
Device: Intralink
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Oswestry Disability Index (ODI)
時間枠：1 Month compared to Baseline
|
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.
時間枠：Through 1 Month post procedure
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Frequency of serious adverse events post implant |
Through 1 Month post procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluate type of adverse events
時間枠：Baseline through 6 months post procedure
|
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
時間枠：3, 6, 12, and 24 months post procedure
|
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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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