Stronger Together Global Registry
Evaluating Real-World Spine Outcomes for Spinal and Orthobiologics Products From Around the World
1 other identifier
observational
2,285
1 country
2
Brief Summary
A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2020
CompletedFirst Submitted
Initial submission to the registry
April 23, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
April 4, 2023
March 1, 2023
7.9 years
April 23, 2020
March 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of product failure
Product failure is defined as product fracture, loosening, gross migration and/or dissociation.
12 months post-operative
Secondary Outcomes (1)
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
Study Arms (1)
Implanted with SeaSpine spinal or orthobiologics product
Standard of Care Registry- Patients must have been implanted with at least one SeaSpine product
Interventions
Implanted with SeaSpine spinal or orthobiologic product
Eligibility Criteria
Approximately 2285 patients who were previously implanted with SeaSpine products
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SeaSpine, Inc.lead
Study Sites (2)
Spine Colorado
Durango, Colorado, 81301, United States
OrthoNeuro
New Albany, Ohio, 43054, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Frank Vizesi, PhD
SeaSpine Orthopedics Corporation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2020
First Posted
April 28, 2020
Study Start
March 20, 2020
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
April 4, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share