Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2022-03-23
2027-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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OssDsign® Catalyst
An osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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OssDsign
INDUSTRY
Responsible Party
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Principal Investigators
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Melanie Marshall
Role: STUDY_DIRECTOR
OssDsign
Locations
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Community Health Partners Neuroscience
Fresno, California, United States
San Diego Neurosurgery
San Diego, California, United States
Orthopedic Associates of Hartford
Hartford, Connecticut, United States
Central Connecticut Neurosurgery and Spine
New Britian, Connecticut, United States
Yale Center for Clinical Investigation, Yale School of Medicine
New Haven, Connecticut, United States
Minimally Invasive Spine Center of South Florida
Miami, Florida, United States
Foundation for Orthopaedic Research and Education
Tampa, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Carle Foundation Hospital, NeuroScience Institute
Urbana, Illinois, United States
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States
OrthoBethesda Research Foundation
Bethesda, Maryland, United States
Twin Cities Orthopedics
Edina, Minnesota, United States
University Orthopedics Center
State College, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OSD202101
Identifier Type: -
Identifier Source: org_study_id
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