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NCT05144126 Clinical Trial

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

Degenerative Disc Disease Clinical Trial

— CAPREG  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05144126
Other study ID # 21/SP/COM/01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2022
Est. completion date September 2025

Study information
Verified date November 2021
Source CeraPedics, Inc
Contact Shankar Sivshankar, MS
Phone +447975566265
Email ssivshankar@cerapedics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date September 2025
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• CT radioraphic assessment
CT radioraphic assessment

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
CeraPedics, Inc Medical Metrics Diagnostics, Inc, Talosix

Outcome
Type Measure Description Time frame Safety issue
Primary index segment revision Reintervention rate at index segment 12-months post-operative
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