The Fixation Study

March 30, 2023 updated by: SeaSpine, Inc.

Clinical Evaluation of the SeaSpine Non-Cervical Pedicle Screw Systems

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Jackson, Michigan, United States, 49201
        • Henry Ford
    • Ohio
      • New Albany, Ohio, United States, 43054
        • OrthoNeuro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have been implanted with a SeaSpine Non-Cervical Pedicle Screw System

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treated with Non-Cervical Pedicle Screw Systems
50 patients who have been implanted with SeaSpine Non-Cervical Pedicle Screw Systems
Device: SeaSpine Non-Cervical Pedicle Screw Systems
Any patient treated with a SeaSpine Non-Cervical Pedicle Screw System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome for the study is device performance.
Time Frame: 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.
12 months post-operative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SeaSpine, Inc.

Investigators

  • Study Director: Frank Vizesi, Ph.D., SeaSpine, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 6, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SS-PMCF-1905

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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