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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05144126

Acronym

CAPREG

Enrollment

300

Registered

2021-12-03

Start date

2022-01-31

Completion date

2025-09-30

Last updated

2021-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disc Disease

Brief summary

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

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

Interventions

OTHERCT radioraphic assessment

CT radioraphic assessment

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame	Description
index segment revision	12-months post-operative	Reintervention rate at index segment

Contacts

Primary ContactShankar Sivshankar, MS

ssivshankar@cerapedics.com+447975566265

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026