Stronger Together Global Registry for Spinal Disease

This is an observational study called the Stronger Together Global Registry. It's looking at how well SeaSpine spinal or orthobiologic products work in real-world settings after spinal surgery. Researchers want to see if these products fail within 12 months after surgery. You could be included if you've had spinal surgery using at least one SeaSpine product, have had standard pre- and post-operative X-rays or other imaging, and have completed at least one standard pre-operative patient-reported outcome measure (a survey about your health). The study is currently unclear on its recruitment status and plans to include about 2285 people.

Study design: This is an observational study, meaning researchers will collect information from medical records rather than assigning treatments. It aims to include about 2285 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The study evaluates product failure at 12 months post-operative.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Stronger Together Global Registry

Enrolling by Invitation

Not specifiedAll AgesObservational

SeaSpine, Inc.

~2,285 participants

Updated 2023-04-04 on ClinicalTrials.gov

What's tested:Spinal Surgery with SeaSpine product

At a glance

Recruiting sites

0 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Evaluation of product failure

Measured over 12 months post-operative

Conditions

Spinal Disease

Where it's being run

2 sites across 2 states

Colorado1

Ohio1

Study leadership

Frank Vizesi, PhD · STUDY_DIRECTOR · SeaSpine Orthopedics Corporation

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

Evaluation of product failure12 months post-operative
Product failure is defined as product fracture, loosening, gross migration and/or dissociation.

Trialytics