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
5000 participants
OBSERVATIONAL
2020-01-28
2025-06-30
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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RTI Spine products
* Interbody fusion devices - intended to help facilitate fusion by providing a platform for bone growth, while maintaining height and decompression.
* Supplemental fixation and/or stabilization devices - are intended to stabilize the spine to allow for fusion to occur, maintain current spinal movement, correct deformities or curvature, treat trauma, spinal stenosis, tumor and pseudarthrosis.
* Bone graft substitute - is intended to aid in fusion.
Eligibility Criteria
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Inclusion Criteria
2. Willing and able to consent to the study.
Exclusion Criteria
3. Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator may prevent participation or otherwise render patient ineligible for the study.
18 Years
ALL
No
Sponsors
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Xtant Medical
INDUSTRY
Responsible Party
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Locations
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Hartford Hospital
Hartford, Connecticut, United States
Florida Back Institute
Boca Raton, Florida, United States
Spine Institute of South Florida
Delray Beach, Florida, United States
Suburban Orthopaedics
Bartlett, Illinois, United States
Indiana Spine Group
Carmel, Indiana, United States
DK Orthopedics
Crown Point, Indiana, United States
Lindner Center for Research & Education at The Christ Hospit
Cincinnati, Ohio, United States
STENUM Ortho Fachklinik
Ganderkesee, , Germany
Wirbelsäulenzentrum Fulda | Main | Kinzig
Gelnhausen, , Germany
Katholisches Klinikum Koblenz - Montabaur
Koblenz, , Germany
St. Christopherus Krankenhaus - Katholisches Klinikum
Werne, , Germany
Hospital Nacional de Parapléjicos
Toledo, , Spain
Countries
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Central Contacts
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Facility Contacts
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María Elena Alonso
Role: primary
Other Identifiers
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19094
Identifier Type: -
Identifier Source: org_study_id
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