Stronger Together Global Registry

March 30, 2023 updated by: SeaSpine, Inc.

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2285

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Durango, Colorado, United States, 81301
        • Spine Colorado
    • Ohio
      • New Albany, Ohio, United States, 43054
        • OrthoNeuro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 2285 patients who were previously implanted with SeaSpine products

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Implanted with SeaSpine spinal or orthobiologics product
Standard of Care Registry- Patients must have been implanted with at least one SeaSpine product
Device: Spinal Surgery with SeaSpine product
Implanted with SeaSpine spinal or orthobiologic product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of product failure
Time Frame: 12 months post-operative
Product failure is defined as product fracture, loosening, gross migration and/or dissociation.
12 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intra-operative to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SeaSpine, Inc.

Investigators

  • Study Director: Frank Vizesi, PhD, SeaSpine Orthopedics Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2020

Primary Completion (Anticipated)

February 1, 2028

Study Completion (Anticipated)

August 1, 2028

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SS-GR-1902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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