Registry to collect data on RTI spine products
Prospective Study on Safety and Performance of Surgalign spINE Products
This study is collecting information on how well RTI's spine products work and their safety for patients needing spine treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xtant Medical Industry-sponsored |
| Locations | 12 sites (Hartford, Connecticut and 11 other locations) |
| Trial ID | NCT04176562 on ClinicalTrials.gov |
What this trial studies
This observational study is a prospective, multi-center registry aimed at gathering real-world performance and safety data on RTI's spine products. It involves multiple locations and focuses on patients who are candidates for these specific spine interventions. Participants will be monitored over time to assess outcomes related to sacroiliac and spinal diseases. The study seeks to provide valuable insights into the effectiveness of these products in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who are eligible for RTI spine products and can provide informed consent.
Not a fit: Patients who are not candidates for RTI spine products or those with conditions that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of the safety and effectiveness of RTI spine products, leading to improved patient outcomes.
How similar studies have performed: While this registry approach is common in observational studies, the specific focus on RTI spine products may provide novel insights into their performance.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hartford, Connecticut and 11 other locations
- Hartford Hospital — Hartford, Connecticut, United States (Active_not_recruiting)
- Florida Back Institute — Boca Raton, Florida, United States (Active_not_recruiting)
- Spine Institute of South Florida — Delray Beach, Florida, United States (Active_not_recruiting)
- Suburban Orthopaedics — Bartlett, Illinois, United States (Terminated)
- Indiana Spine Group — Carmel, Indiana, United States (Withdrawn)
- DK Orthopedics — Crown Point, Indiana, United States (Completed)
- Lindner Center for Research & Education at The Christ Hospit — Cincinnati, Ohio, United States (Active_not_recruiting)
- STENUM Ortho Fachklinik — Ganderkesee, Germany (Withdrawn)
- Wirbelsäulenzentrum Fulda | Main | Kinzig — Gelnhausen, Germany (Active_not_recruiting)
- Katholisches Klinikum Koblenz - Montabaur — Koblenz, Germany (Withdrawn)
- St. Christopherus Krankenhaus - Katholisches Klinikum — Werne, Germany (Withdrawn)
- Hospital Nacional de Parapléjicos — Toledo, Spain (Recruiting)
Study contacts
- Study coordinator: Isabella M Rosales, BS
- Email: irosales@xtantmedical.com
- Phone: 406-924-5884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.