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Not yet recruitingNCT05144126CAPREGUpdated Dec 3, 2021

Safety, Radiological and Patient Reported Outcomes of i-FACTOR+ Matrix Bone Graft Device - A Canadian, Multicenter, Post-Market Clinical Investigation

An interventional study of CT radioraphic assessment in Degenerative Disc Disease, sponsored by CeraPedics, Inc. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-03.

Sponsored by CeraPedics, Inc · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study intends tracking the usage patterns of a Bonegraft device within spine surgery in a multicenter setting in Canada.

Read the detailed description

The study wil track the usage patterns of a bone graft by identifying and classifying spine surgery procedures by access and segment type within the spins and furthet, record and analyse safety and performance measures associated with each classification. This is a post-market surveillance study

02

Conditions studied

  • Degenerative Disc Disease
03

In context

Intervertebral Disc Degeneration

464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.

This study's planned enrollment of 300 is above the median of 60 across 261 interventional studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

CeraPedics, Inc is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patient subjects not responding to conservative management of neck / arm or back/leg pain and requiring spinal fusion between levels C1 - T2 or L1 - S1
  • Informed Consent

Exclusion criteria

Exclusion Criteria:

  • Hypersensitivity to i-FACTOR Bone Graft Devices
  • Adult Spinal deformity, Spinal Cord Injury
  • Infection
  • Compromised renal function
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    i-Factor Arm

    All patients undergoing spine fusion surgery will be treated with i-FACTOR

    Other: CT radioraphic assessment

Interventions

  • OtherCT radioraphic assessment

    CT radioraphic assessment

06

What researchers measure

Primary outcomes

  1. index segment revision

    Reintervention rate at index segment

    Time frame: 12-months post-operative

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05144126
Lead sponsor
CeraPedics, Inc
Collaborators
Talosix, Medical Metrics Diagnostics, Inc
Responsible party
Sponsor
First posted
Dec 3, 2021
Start date
Jan 2022 (estimated)
Primary completion
May 2024 (estimated)
Completion
Sep 2025 (estimated)
Last update
Dec 3, 2021

Study contacts

Shankar Sivshankar, MS
Contact
ssivshankar@cerapedics.com
+447975566265
Christopher Witiw, MD
principal investigator · St Michael's Hosptal Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Intervertebral Disc Degeneration→

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