NCT04364295Enrolling By InvitationNot Applicable
Evaluating Real-World Spine Outcomes for Spinal and Orthobiologics Products From Around the World
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- SeaSpine, Inc.
- Enrollment
- 2,285
- Locations
- 2
- Primary Endpoint
- Evaluation of product failure
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Evaluation of product failure
Time Frame: 12 months post-operative
Product failure is defined as product fracture, loosening, gross migration and/or dissociation.
Secondary Outcomes
- Incidence of product-related Serious Adverse Events (SAEs) related to the spine, fusion or bone healing, and intraoperative and postoperative unanticipated adverse device effects(Intra-operative to 24 months)
Investigators
Study Sites (2)
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