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

CeraPedics, Inc300 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Degenerative Disc Disease

Interventions

CT radioraphic assessmentOTHER

CT radioraphic assessment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

index segment revision

Reintervention rate at index segment

Time frame: 12-months post-operative

Central Contacts

Shankar Sivshankar, MS

CONTACT

+447975566265 ssivshankar@cerapedics.com

Data from ClinicalTrials.gov

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