Stronger Together Global Registry

SeaSpine

Status: Invitation-only

Conditions: Spinal Disease

Treatments: Device: Spinal Surgery with SeaSpine product

Study type: Observational

Funder types: Industry

Identifiers

NCT04364295

SS-GR-1902

Details and patient eligibility

About

A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.

Full 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.

Enrollment: 2,285 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

2,285 participants in 1 patient group

Implanted with SeaSpine spinal or orthobiologics product

Description:

Standard of Care Registry- Patients must have been implanted with at least one SeaSpine product

Treatment:

Device: Spinal Surgery with SeaSpine product