PROSPECTIVE OBSERVATIONAL SPINE FUSION REGISTRY FOR OssDsign® BONE GRAFT SUBSTITUTES IN REAL WORLD CLINICAL PRACTICE
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- STATUS
- Recruiting
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- End date
- Mar 23, 2024
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- participants needed
- 300
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- sponsor
- OssDsign
Summary
The purpose of this multi-center, prospective, observational registry is to gather information on the clinical outcomes and real-world use of commercially available bone graft substitutes manufactured by OssDsign® AB, in patients who require spine fusion.
Description
This multi-center study (up to 10 US study sites) is a post market, prospective, observational spine fusion registry. The outcomes of patients undergoing spine fusion with OssDsign® bone grafts will be documented and evaluated for the purposes of post market clinical follow up as part of OssDsign® post market surveillance activities. The length of study duration and number to be recruited is open-ended but initially a target of 300 subjects will be recruited and followed up for a period of 24 months ± 90 days after their index surgery in which an OssDsign® bone graft has been implanted.
Details
| Condition | Degenerative Disc Disease, Spinal Stenosis |
|---|---|
| Treatment | OssDsign® Catalyst |
| Clinical Study Identifier | NCT05329129 |
| Sponsor | OssDsign |
| Last Modified on | 25 October 2022 |
Eligibility
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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