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

Primary Purpose

Degenerative Disc Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CT radioraphic assessment
Sponsored by
CeraPedics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    i-Factor Arm

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    index segment revision
    Reintervention rate at index segment

    Secondary Outcome Measures

    Full Information

    First Posted
    November 21, 2021
    Last Updated
    November 21, 2021
    Sponsor
    CeraPedics, Inc
    Collaborators
    Talosix, Medical Metrics Diagnostics, Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05144126
    Brief Title
    Safety, Radiological and Patient Reported Outcomes of i-FACTOR+ Matrix Bone Graft Device - A Canadian, Multicenter, Post-Market Clinical Investigation
    Acronym
    CAPREG
    Official Title
    Safety, Radiological and Patient Reported Outcomes of i-FACTOR+ Matrix Bone Graft Device - A Canadian, Multicenter, Post-Market Clinical Investigation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    September 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CeraPedics, Inc
    Collaborators
    Talosix, Medical Metrics Diagnostics, Inc

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Degenerative Disc Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    i-Factor Arm
    Arm Type
    Experimental
    Arm Description
    All patients undergoing spine fusion surgery will be treated with i-FACTOR
    Intervention Type
    Other
    Intervention Name(s)
    CT radioraphic assessment
    Intervention Description
    CT radioraphic assessment
    Primary Outcome Measure Information:
    Title
    index segment revision
    Description
    Reintervention rate at index segment
    Time Frame
    12-months post-operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shankar Sivshankar, MS
    Phone
    +447975566265
    Email
    ssivshankar@cerapedics.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher Witiw, MD
    Organizational Affiliation
    St Michael's Hosptal Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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