The Fixation Study

Clinical Evaluation of the SeaSpine Non-Cervical Pedicle Screw Systems

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04300777

Enrollment

Registered

2020-03-09

Start date

2020-03-05

Completion date

2023-06-30

Last updated

2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Conditions, Neurologic

Brief summary

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

Detailed description

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

Interventions

DEVICESeaSpine Non-Cervical Pedicle Screw Systems

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The primary outcome for the study is device performance.	12 months post-operative	Device performance is defined as lack of component failure involving screw and/or rod fracture and/or screw loosening or disassociation.

Secondary

Measure	Time frame	Description
Evaluation of unanticipated adverse device effects (UADE)	12-months	Intra or Post-Procedure UADEs

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026