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

November 21, 2021 updated by: CeraPedics, Inc
The study intends tracking the usage patterns of a Bonegraft device within spine surgery in a multicenter setting in Canada.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: i-Factor Arm
All patients undergoing spine fusion surgery will be treated with i-FACTOR
Other: CT radioraphic assessment
CT radioraphic assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
index segment revision
Time Frame: 12-months post-operative
Reintervention rate at index segment
12-months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CeraPedics, Inc

Collaborators

Talosix
Medical Metrics Diagnostics, Inc

Investigators

  • Principal Investigator: Christopher Witiw, MD, St Michael's Hosptal Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

November 21, 2021

First Submitted That Met QC Criteria

November 21, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

December 3, 2021

Last Update Submitted That Met QC Criteria

November 21, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21/SP/COM/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Degenerative Disc Disease

Clinical Trials on CT radioraphic assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe