Stronger Together Global Registry

Spinal Disease Clinical Trial

Official title:

Evaluating Real-World Spine Outcomes for Spinal and Orthobiologics Products From Around the World

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04364295
• Other study ID #: SS-GR-1902
• Status: Enrolling by invitation
• Start date: March 20, 2020
• Est. completion date: August 2028

Study information

• Verified date: March 2023
• Source: SeaSpine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2285
• Est. completion date: August 2028
• Est. primary completion date: February 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Disease
• Spinal Diseases

Intervention

Device:
• Spinal Surgery with SeaSpine product
Implanted with SeaSpine spinal or orthobiologic product

Locations

Country	Name	City	State
United States	Spine Colorado	Durango	Colorado
United States	OrthoNeuro	New Albany	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
SeaSpine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of product failure	Product failure is defined as product fracture, loosening, gross migration and/or dissociation.	12 months post-operative
Secondary	Incidence of product-related Serious Adverse Events (SAEs) related to the spine, fusion or bone healing, and intraoperative and postoperative unanticipated adverse device effects	Product-related SAEs related to the spine, fusion, or bone will be collected for this outcome measure.	Intra-operative to 24 months