Stronger Together Global Registry

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04364295
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	SeaSpine, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Frank Vizesi, PhD
Principal Investigator Affiliation	SeaSpine Orthopedics Corporation
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spinal Disease

Additional Details

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

Arms & Interventions

Arms

: Implanted with SeaSpine spinal or orthobiologics product

Standard of Care Registry- Patients must have been implanted with at least one SeaSpine product

Interventions

Device: - Spinal Surgery with SeaSpine product

Implanted with SeaSpine spinal or orthobiologic product

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Spine Colorado, Durango, Colorado

Status

Address

Spine Colorado

Durango, Colorado, 81301

OrthoNeuro, New Albany, Ohio

Status

Address

OrthoNeuro

New Albany, Ohio, 43054

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