The Fixation Study

Active, not recruiting

• Conditions: Degenerative Conditions, Neurologic
• Interventions: Device: SeaSpine Non-Cervical Pedicle Screw Systems

• Registration Number: NCT04300777
• Lead Sponsor: SeaSpine, Inc.

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

Study Timeline

• Study Start: 2020-03-05
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-09
• Primary Completion: 2021-06-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-04-04
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated with Non-Cervical Pedicle Screw Systems	SeaSpine Non-Cervical Pedicle Screw Systems	50 patients who have been implanted with SeaSpine Non-Cervical Pedicle Screw Systems

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evaluation of unanticipated adverse device effects (UADE)	12-months	Intra or Post-Procedure UADEs

Trial Locations

Locations (2)

Henry Ford; 🇺🇸 Jackson, Michigan, United States

OrthoNeuro; 🇺🇸 New Albany, Ohio, United States