OssDsign® Spine Registry Study ("Propel")

OssDsign

Status: Enrolling

Conditions: Degenerative Disc Disease; Spinal Stenosis

Treatments: Device: OssDsign® Catalyst

Study type: Observational

Funder types: Industry

Identifiers

NCT05329129

OSD202101

Details and patient eligibility

About

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.

Full description

This multi-center study (up to 15 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 450 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• The patient has been diagnosed as a candidate for spinal fusion surgery for which the surgeon has decided an OssDsign® bone graft is appropriate.
• The patient is ≥21 years old.
• The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent
• The patient is willing and able to participate in post- operative clinical and radiographic follow up evaluations for 2 years.

Exclusion Criteria:

• Patients not meeting all of the inclusion criteria