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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04364295
Other study ID # SS-GR-1902
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 20, 2020
Est. completion date August 2028

Study information

Verified date March 2023
Source SeaSpine, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Spinal Surgery with SeaSpine product
Implanted with SeaSpine spinal or orthobiologic product

Locations

Country Name City State
United States Spine Colorado Durango Colorado
United States OrthoNeuro New Albany Ohio

Sponsors (1)

Lead Sponsor Collaborator
SeaSpine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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