Prospective SPINE Registry

Recruiting

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

• Registration Number: NCT04176562
• Lead Sponsor: Xtant Medical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-25
• Study Start: 2020-01-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intervention Rates	1 month, 3 months, 6 months, 12 months, and 24 months	Rates of reoperation and/or revision procedures at index level

Secondary Outcome Measures

Name	Time	Method
Disability (non-Cervical)	1 month, 3 months, 6 months, 12 months, and 24 months	Change in Oswestry Disability Index
Pain Change	1 month, 3 months, 6 months, 12 months, and 24 months	Change in pain as determined by Visual Analogue Scale (VAS)
Fusion	1 month, 3 months, 6 months, 12 months, and 24 months	Fusion success measures by radiological assessment (x-ray, CT scan, MRI, etc.)
Time to Intervention	1 month, 3 months, 6 months, 12 months, and 24 months	Time to first reoperation and/or revision procedure at index leve
Radiographic Findings	1 month, 3 months, 6 months, 12 months, and 24 months	Change in radiographic findings
Adverse Events	1 month, 3 months, 6 months, 12 months, and 24 months	Number of procedure and device related adverse events
Disability (Cervical)	1 month, 3 months, 6 months, 12 months, and 24 months	Change in Neck Disability Index

Trial Locations

Locations (12)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Florida Back Institute; 🇺🇸 Boca Raton, Florida, United States

Spine Institute of South Florida; 🇺🇸 Delray Beach, Florida, United States

DK Orthopedics; 🇺🇸 Crown Point, Indiana, United States

Suburban Orthopaedics; 🇺🇸 Bartlett, Illinois, United States

Indiana Spine Group; 🇺🇸 Carmel, Indiana, United States

Hospital Nacional de Parapléjicos; 🇪🇸 Toledo, Spain

STENUM Ortho Fachklinik; 🇩🇪 Ganderkesee, Germany

Katholisches Klinikum Koblenz - Montabaur; 🇩🇪 Koblenz, Germany

Wirbelsäulenzentrum Fulda | Main | Kinzig; 🇩🇪 Gelnhausen, Germany

Lindner Center for Research & Education at The Christ Hospit; 🇺🇸 Cincinnati, Ohio, United States

St. Christopherus Krankenhaus - Katholisches Klinikum; 🇩🇪 Werne, Germany