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Prospective SPINE Registry

NCT04176562 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2024-03-12

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Xtant Medical

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-28
Primary Completion
2025-03-31
Completion
2025-06-30
FDA Device
Yes

Countries

  • United States
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04176562 on ClinicalTrials.gov