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

Not Applicable

Not yet recruiting

• Conditions: Degenerative Disc Disease

• Registration Number: NCT05144126
• Lead Sponsor: CeraPedics, Inc

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

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-21
• Study First Submitted QC: 2021-11-21
• Last Update Submitted: 2021-11-21
• Study First Posted: 2021-12-03
• Last Update Posted: 2021-12-03
• Study Start: 2022-01
• Primary Completion: 2024-05
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
index segment revision	12-months post-operative	Reintervention rate at index segment