Spinal Disease Clinical Trial
Official title:
Evaluating Real-World Spine Outcomes for Spinal and Orthobiologics Products From Around the World
Verified date | March 2023 |
Source | SeaSpine, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.
Status | Enrolling by invitation |
Enrollment | 2285 |
Est. completion date | August 2028 |
Est. primary completion date | February 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Spine Colorado | Durango | Colorado |
United States | OrthoNeuro | New Albany | Ohio |
Lead Sponsor | Collaborator |
---|---|
SeaSpine, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of product failure | Product failure is defined as product fracture, loosening, gross migration and/or dissociation. | 12 months post-operative | |
Secondary | Incidence of product-related Serious Adverse Events (SAEs) related to the spine, fusion or bone healing, and intraoperative and postoperative unanticipated adverse device effects | Product-related SAEs related to the spine, fusion, or bone will be collected for this outcome measure. | Intra-operative to 24 months |
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