Prospective Study on Safety and Performance of Surgalign spINE Products

Xtant Medical12 sites in 3 countries5,000 target enrollmentJanuary 28, 2020

ConditionsSacroiliac; Fusion Sacroiliac Joint Diseases Musculoskeletal Diseases Spinal Disease Spinal Stenosis Spinal Instability Fusion of Joint Fusion of Spine Spinal Fusion Spine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sacroiliac; Fusion
Sponsor: Xtant Medical
Enrollment: 5000
Locations: 12
Primary Endpoint: Intervention Rates
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 28, 2020

End Date

June 2025

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Xtant Medical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Intervention Rates

Time Frame: 1 month, 3 months, 6 months, 12 months, and 24 months

Rates of reoperation and/or revision procedures at index level

Secondary Outcomes

Disability (Cervical)(1 month, 3 months, 6 months, 12 months, and 24 months)
Fusion(1 month, 3 months, 6 months, 12 months, and 24 months)
Time to Intervention(1 month, 3 months, 6 months, 12 months, and 24 months)
Radiographic Findings(1 month, 3 months, 6 months, 12 months, and 24 months)
Adverse Events(1 month, 3 months, 6 months, 12 months, and 24 months)
Disability (non-Cervical)(1 month, 3 months, 6 months, 12 months, and 24 months)
Pain Change(1 month, 3 months, 6 months, 12 months, and 24 months)