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).

Study Overview

• Status: Not yet recruiting
• Conditions: Degenerative Disc Disease(DDD)
• Intervention / Treatment: Device: Pain treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Echo Cundiff, Director of Clinical Research; Phone Number: 815-848-4189; Email: ecundiff@spinalsimplicity.com

Study Locations

• Canada
  • Calgary, Canada
    • Beam Radiology
    • Contact: Kimberly Clinical Research Manager; Phone Number: 587-885-2988; Email: kcarcary@beamradiology.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Intralink Device	Device: Pain treatment; Device: Intralink; Other Names: Intralink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	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
Assess occurrence of serious adverse events post-treatment.	Frequency of serious adverse events post implant	Through 1 Month post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate type of adverse events	Incidence and type of adverse events (AEs) and serious adverse events (SAEs)	Baseline through 6 months post procedure
Assess change from baseline in mean disability scores using Oswestry Disability Index (ODI) 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
Assess change from baseline in mean pain scores using Visual Analog Scale (VAS)	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
Evaluate change of baseline spinal instability using flexion-extension radiographic imaging	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
Assess use of escalated interventions post-procedure	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
Patient Global Impression of Change (PGIC)	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
Patient Satisfaction	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

Collaborators and Investigators

• Sponsor: Spinal Simplicity LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: October 27, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 6, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration; Anesthesia and Analgesia; Analgesia
• Other Study ID Numbers: CANLINK-2026-CIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No