Clinical Trials in the USA / NCT04364295
Enrolling by invitation
Observational
Stronger Together Global Registry
NCT04364295 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Spinal Disease
Investigational drug(s) / intervention(s)
Spinal Surgery with SeaSpine product
Spinal Surgery with SeaSpine product: Implanted with SeaSpine spinal or orthobiologic product
Study summary
A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.
Eligibility
Inclusion Criteria:
* Have been treated with at least one SeaSpine product.
* Have obtained radiographic imaging, as part of the standard of care, at the following time points: preoperative and postoperative.
* Have obtained at least one preoperative patient-reported outcome measure, as part of the standard of care.
* Patient is planned, per standard of care, to be assessed with radiographic imaging and consistent patient-reported outcome measure(s) from preoperative through at least two scheduled follow-up visits.
Exclusion Criteria:
* Was not implanted with at least one SeaSpine product during operation
* Any other condition that the Investigator determines is unacceptable for enrollment into this registry
Primary outcome measure(s)
- Evaluation of product failure — 12 months post-operative
Product failure is defined as product fracture, loosening, gross migration and/or dissociation.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Spine Colorado | Durango | Colorado | |
| OrthoNeuro | New Albany | Ohio |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04364295 on ClinicalTrials.gov ↗ ← All trials in the USA