Stronger Together Global Registry

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

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Key information

Conditions

Spinal Disease Bone Diseases Musculoskeletal Diseases Spinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Spine Colorado, Durango, Colorado, United States

About this study

To gain observational, prospective, real-world clinical, and radiographic data in order to evaluate continued safety and performance following the implantation of SeaSpine products.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal Surgery with SeaSpine product

Device

Implanted with SeaSpine spinal or orthobiologic product

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

Time frame: Intra-operative to 24 months

Product-related SAEs related to the spine, fusion, or bone will be collected for this outcome measure.

Sponsors and collaborators

Lead sponsor

SeaSpine, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2028
Study completion: 2028
First posted: Apr 28, 2020
Registry last updated: Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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