OssDsign® Spine Registry Study ("Propel")
Purpose
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.
Conditions
- Degenerative Disc Disease
- Spinal Stenosis
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Fresno, California 93720
Long Beach, California 90806
New Britian, Connecticut 06051
New Haven, Connecticut 06519
Miami, Florida 33133
Tampa, Florida 33607
State College, Pennsylvania 16801
More Details
- Status
- Recruiting
- Sponsor
- OssDsign
Detailed Description
This multi-center study (up to 25 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 750 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.