Spinal Disease
Conditions
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.
Interventions
DEVICESpinal Surgery with SeaSpine product
Implanted with SeaSpine spinal or orthobiologic product
Sponsors
SeaSpine, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of product failure | 12 months post-operative | Product failure is defined as product fracture, loosening, gross migration and/or dissociation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Product-related SAEs related to the spine, fusion, or bone will be collected for this outcome measure. |
Countries
United States
Outcome results
None listed