CeraPedics, Inc
The study intends tracking the usage patterns of a Bonegraft device within spine surgery in a multicenter setting in Canada.
Degenerative Disc Disease
CT radioraphic assessment
Not Applicable
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 Type : | Interventional |
| Estimated Enrollment : | 300 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Treatment |
| Official Title : | Safety, Radiological and Patient Reported Outcomes of i-FACTOR+ Matrix Bone Graft Device - A Canadian, Multicenter, Post-Market Clinical Investigation |
| Actual Study Start Date : | January 2022 |
| Estimated Primary Completion Date : | May 2024 |
| Estimated Study Completion Date : | September 2025 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: i-Factor Arm All patients undergoing spine fusion surgery will be treated with i-FACTOR |
Other: CT radioraphic assessment |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.