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Clinical Trials/NCT05144126
NCT05144126Not yet recruitingNot Applicable

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

CeraPedics, Inc0 sites300 target enrollmentStarted: January 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
300
Primary Endpoint
index segment revision
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Time Frame: 12-months post-operative

Reintervention rate at index segment

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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Safety, Radiological and Patient Reported... | Clinical Trial