Trials / Unknown
UnknownNCT04176562
Prospective SPINE Registry
Prospective Study on Safety and Performance of Surgalign spINE Products
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 5,000 (estimated)
- Sponsor
- Xtant Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-01-28
- Primary completion
- 2025-03-01
- Completion
- 2025-06-01
- First posted
- 2019-11-25
- Last updated
- 2024-03-12
Locations
12 sites across 3 countries: United States, Germany, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04176562. Inclusion in this directory is not an endorsement.