Stronger Together Global Registry

• Conditions: Spinal Disease
• Interventions: Device: Spinal Surgery with SeaSpine product

• Registration Number: NCT04364295
• Lead Sponsor: SeaSpine, Inc.

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 Timeline

• Study Start: 2020-03-20
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-04-04
• Primary Completion: 2028-02
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2285

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Implanted with SeaSpine spinal or orthobiologics product	Spinal Surgery with SeaSpine product	Standard of Care Registry- Patients must have been implanted with at least one SeaSpine product

Primary Outcome Measures

Name	Time	Method
Evaluation of product failure	12 months post-operative	Product failure is defined as product fracture, loosening, gross migration and/or dissociation.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Spine Colorado; 🇺🇸 Durango, Colorado, United States

OrthoNeuro; 🇺🇸 New Albany, Ohio, United States