Safety, Radiological and Patient Reported Outcomes of i-FACTOR+ Matrix Bone Graft Device - A Canadian, Multicenter, Post-Market Clinical Investigation
Not Applicable
Not yet recruiting
- Conditions
- Degenerative Disc Disease
- Interventions
- Other: CT radioraphic assessment
- Registration Number
- NCT05144126
- Lead Sponsor
- CeraPedics, Inc
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description i-Factor Arm CT radioraphic assessment All patients undergoing spine fusion surgery will be treated with i-FACTOR
- Primary Outcome Measures
Name Time Method index segment revision 12-months post-operative Reintervention rate at index segment
- Secondary Outcome Measures
Name Time Method