Other Clinical Trial - The Fixation Study NCT04300777

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Active, not recruiting

To perform a clinical evaluation of safety and performance for the SeaSpine Non- Cervical Pedicle Screw Systems

A multi-center, post-market, clinical evaluation for subjects implanted with the SeaSpine Non-Cervical Pedicle Screw Systems

Recruitment information / eligibility
Status	Active, not recruiting
Enrollment	50
Est. completion date	June 30, 2023
Est. primary completion date	June 30, 2021
Accepts healthy volunteers	No
Gender	All
Age group	N/A and older
Eligibility	Inclusion Criteria: - Have undergone surgery - Have undergone at least 12-months of postoperative follow-up Exclusion Criteria: - Any condition that the Investigator determines is unacceptable

Device:
• SeaSpine Non-Cervical Pedicle Screw Systems
Any patient treated with a SeaSpine Non-Cervical Pedicle Screw System

Locations
Country	Name	City	State
United States	Henry Ford	Jackson	Michigan
United States	OrthoNeuro	New Albany	Ohio

Sponsors *(1)*
Lead Sponsor	Collaborator
SeaSpine, Inc.

United States,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome for the study is device performance.	Device performance is defined as lack of component failure involving screw and/or rod fracture and/or screw loosening or disassociation.	12 months post-operative
Secondary	Evaluation of unanticipated adverse device effects (UADE)	Intra or Post-Procedure UADEs	12-months