Status:
ENROLLING_BY_INVITATION
Stronger Together Global Registry
Lead Sponsor:
SeaSpine, Inc.
Conditions:
Spinal Disease
Eligibility:
All Genders
Brief Summary
A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.
Detailed Description
To gain observational, prospective, real-world clinical, and radiographic data in order to evaluate continued safety and performance following the implantation of SeaSpine products.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
2285 Patients enrolled
Trial Details
Trial ID
NCT04364295
Start Date
March 20 2020
End Date
August 1 2028
Last Update
April 4 2023
Active Locations (2)
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1
Spine Colorado
Durango, Colorado, United States, 81301
2
OrthoNeuro
New Albany, Ohio, United States, 43054