An observational study in Sacroiliac; Fusion, Sacroiliac and Joint Diseases, sponsored by Xtant Medical. Recruiting at 12 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Xtant Medical · Observational
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.
386 studies on the registry are indexed under Joint Diseases; 64 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 86 across 116 observational studies indexed under Joint Diseases.
Browse Joint Diseases studies →Xtant Medical is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients that have spinal problems requiring treatment with an RTI Surgical spine product.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
* 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.
Intervention Rates
Rates of reoperation and/or revision procedures at index level
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Fusion
Fusion success measures by radiological assessment (x-ray, CT scan, MRI, etc.)
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Radiographic Findings
Change in radiographic findings
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Adverse Events
Number of procedure and device related adverse events
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Disability (Cervical)
Change in Neck Disability Index
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Disability (non-Cervical)
Change in Oswestry Disability Index
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Pain Change
Change in pain as determined by Visual Analogue Scale (VAS)
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Time to Intervention
Time to first reoperation and/or revision procedure at index leve
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
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Plan to share: No — There is no plan to share IPD
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Xtant Medical