The Fixation Study

SeaSpine, Inc.50 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Degenerative Conditions, Neurologic

Interventions

SeaSpine Non-Cervical Pedicle Screw SystemsDEVICE

Any patient treated with a SeaSpine Non-Cervical Pedicle Screw System

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (2)

Henry Ford

Jackson, Michigan, United States

OrthoNeuro

New Albany, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months post-operative

Secondary Outcomes

Evaluation of unanticipated adverse device effects (UADE)

Intra or Post-Procedure UADEs

Time frame: 12-months

Data from ClinicalTrials.gov

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