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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05329129
Study type Observational
Source OssDsign
Contact Jeff Feldhaus
Phone 13476694903
Email jfeldhaus@msquaredassociates.com
Status Recruiting
Phase
Start date March 23, 2022
Completion date April 1, 2027

See also
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