OssDsign® Spine Registry Study ("Propel")

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	21 Years and Over
Gender	All

More Inclusion & 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05329129
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	OssDsign
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Melanie Marshall
Principal Investigator Affiliation	OssDsign
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Degenerative Disc Disease, Spinal Stenosis

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Community Health Partners Neuroscience, Fresno, California

Status

Recruiting

Address

Community Health Partners Neuroscience

Fresno, California, 93720

Site Contact

Allyssa Gomez, CRC

[email protected]

13476694903

San Diego Neurosurgery, San Diego, California

Status