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

Cerapedics

Status: Not yet enrolling

Conditions: Degenerative Disc Disease

Treatments: Other: CT radioraphic assessment

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05144126

21/SP/COM/01

Details and patient eligibility

About

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

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

i-Factor Arm

Experimental group

Description:

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

Treatment:

Other: CT radioraphic assessment