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Degenerative Disc Disease(DDD)NCT07923565

CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease

A study testing Pain treatment in people with Degenerative Disc Disease(DDD), run by Spinal Simplicity LLC at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 22 to 80 years
Conditions the study is for
Degenerative Disc Disease(DDD)
What is being tested?
Pain treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
Jan 2027to Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Echo Cundiff, Director of Clinical Research contact

815-848-4189

ecundiff@spinalsimplicity.com

Canada1 site

  • Beam Radiology

    Calgary

    Kimberly Clinical Research Manager, 587-885-2988, kcarcary@beamradiology.com

Other trials in Canada

About this study

Official title: 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).

Read the 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.

Being tested
Pain treatment
Medical subject headings
Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain treatmentDevice

    Also called Intralink

    Device: Intralink

Study groups in NCT07923565
Study groupRoleWhat they receive
TreatmentExperimentalIntralink Device
Receives: Device: Pain treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 Month compared to Baseline

  2. Assess occurrence of serious adverse events post-treatment.

    Frequency of serious adverse events post implant

    Measured: Through 1 Month post procedure

Secondary outcomes (7)

  1. Evaluate type of adverse events

    Incidence and type of adverse events (AEs) and serious adverse events (SAEs)

    Measured: Baseline through 6 months post procedure

  2. 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.

    Measured: 3, 6, 12, and 24 months post procedure

  3. 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".

    Measured: 1, 3, 5, 12, and 24 months post procedure

  4. 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

    Measured: Baseline, 1, 3, 5, 12, and 24 months

  5. 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.

    Measured: From Baseline to 1, 3, 6, 12, and 24 months

  6. 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.

    Measured: 1, 3, 6, 12, and 24 months post-implant

  7. 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

    Measured: 1, 3, 6, 12, and 24 months post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07923565
Sponsor's protocol ID
CANLINK-2026-CIP
Status last verified
Nov 2026
First submitted
27 Oct 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 37583391

  • 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.

    PubMed 40281749

  • 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.

    PubMed 38927771

Questions about this trial

What is this clinical trial studying?

A study testing Pain treatment in people with Degenerative Disc Disease(DDD), run by Spinal Simplicity LLC at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Echo Cundiff, Director of Clinical Research (815-848-4189, ecundiff@spinalsimplicity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oswestry Disability Index (ODI) (time frame: 1 Month compared to Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07923565, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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