NCT04300777

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

March 5, 2020

Last Update Submit

March 30, 2023

Conditions

Degenerative Conditions, Neurologic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluation of unanticipated adverse device effects (UADE)

    12-months

Study Arms (1)

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

Interventions

SeaSpine Non-Cervical Pedicle Screw SystemsDEVICE

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

Treated with Non-Cervical Pedicle Screw Systems

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Have undergone surgery
  • Have undergone at least 12-months of postoperative follow-up

You may not qualify if:

  • Any condition that the Investigator determines is unacceptable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Henry Ford

Jackson, Michigan, 49201, United States

Location

OrthoNeuro

New Albany, Ohio, 43054, United States

Location

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Frank Vizesi, Ph.D.

    SeaSpine, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 9, 2020

Study Start

March 5, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2023

Last Updated

April 4, 2023

Record last verified: 2023-03

Locations

US(2)