NCT05144126

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

2.3 years

First QC Date

November 21, 2021

Last Update Submit

November 21, 2021

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

  • index segment revision

    Reintervention rate at index segment

    12-months post-operative

Study Arms (1)

i-Factor Arm

EXPERIMENTAL

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

Other: CT radioraphic assessment

Interventions

CT radioraphic assessmentOTHER

CT radioraphic assessment

i-Factor Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hypersensitivity to i-FACTOR Bone Graft Devices
  • Adult Spinal deformity, Spinal Cord Injury
  • Infection
  • Compromised renal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Christopher Witiw, MD

    St Michael's Hosptal Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shankar Sivshankar, MS

CONTACT

+447975566265ssivshankar@cerapedics.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2021

First Posted

December 3, 2021

Study Start

January 1, 2022

Primary Completion

May 1, 2024

Study Completion

September 1, 2025

Last Updated

December 3, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share