Fusion of Joint, Fusion of Spine, Joint Diseases, Musculoskeletal Diseases, Sacroiliac, Sacroiliac; Fusion, Spinal Disease, Spinal Fusion, Spinal Instability, Spinal Stenosis, Spine
Conditions
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.
Interventions
DEVICERTI 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
Xtant Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Rates | 1 month, 3 months, 6 months, 12 months, and 24 months | Rates of reoperation and/or revision procedures at index level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Fusion | 1 month, 3 months, 6 months, 12 months, and 24 months | Fusion success measures by radiological assessment (x-ray, CT scan, MRI, etc.) |
| Pain Change | 1 month, 3 months, 6 months, 12 months, and 24 months | Change in pain as determined by Visual Analogue Scale (VAS) |
| 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 |
| Disability (non-Cervical) | 1 month, 3 months, 6 months, 12 months, and 24 months | Change in Oswestry Disability Index |
Countries
Germany, Spain, United States
Contacts
Primary ContactIsabella M Rosales, BS
Backup ContactLaura Henderson
Outcome results
None listed