Prospective SPINE Registry

Status unconfirmed

Conditions studied: Sacroiliac; Fusion, Sacroiliac, Joint Diseases, Musculoskeletal Diseases, Spinal Disease, Spinal Stenosis, Spinal Instability, Fusion of Joint, Fusion of Spine, Spinal Fusion, Spine

In brief

This study is a prospective, multi-center, open label registry designed to collect real-world data on performance and safety data on RTI's spine products.

Key facts

Study ID

NCT04176562

Run by

Xtant Medical

People needed

5000

Starts

2020-01-28

Expected to finish

2025-06-01

Last updated by the study team

2024-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Candidate for RTI spine product.
• Willing and able to consent to the study.

You may not qualify if…

• Patient who is, or is expected to be inaccessible for follow-up.
• Patient meets any exclusion criteria required by local law (e.g. age, mental capacity, etc.).
• 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.

Where it is running

• Hospital Nacional de Parapléjicos — Toledo, Spain (enrolling)
• 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
• Hartford Hospital — Hartford, Connecticut, 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
• Lindner Center for Research & Education at The Christ Hospit — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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