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

NCT ID: NCT05144126

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2025-09-30

Brief Summary

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

Detailed Description

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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

Conditions

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Degenerative Disc Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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i-Factor Arm

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

Group Type EXPERIMENTAL

CT radioraphic assessment

Intervention Type OTHER

CT radioraphic assessment

Interventions

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CT radioraphic assessment

CT radioraphic assessment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Talosix

UNKNOWN

Sponsor Role collaborator

Medical Metrics Diagnostics, Inc

INDUSTRY

Sponsor Role collaborator

CeraPedics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Witiw, MD

Role: PRINCIPAL_INVESTIGATOR

St Michael's Hosptal Toronto

Central Contacts

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Shankar Sivshankar, MS

Role: CONTACT

Phone: +447975566265

Email: [email protected]

Other Identifiers

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21/SP/COM/01

Identifier Type: -

Identifier Source: org_study_id