Stronger Together Global Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spinal Surgery with SeaSpine product.
- Who it may be relevant to
- Registry conditions: Spinal Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating Real-World Spine Outcomes for Spinal and Orthobiologics Products From Around the World
Overview
A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.
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.
Interventions
- Device Spinal Surgery with SeaSpine product
Implanted with SeaSpine spinal or orthobiologic product
Primary outcome measures
- Evaluation of product failure [Time frame: 12 months post-operative]
Secondary outcome measures (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 [Time frame: Intra-operative to 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Spine Colorado — Durango
- OrthoNeuro — New Albany
Identifiers
NCT: NCT04364295 · SS-GR-1902