ClinicalTrials.gg
Status unknownNCT04300777Updated Apr 4, 2023

The Fixation Study

An observational study in Degenerative Conditions, Neurologic, sponsored by SeaSpine, Inc.. Status unknown at 2 sites in United States. Per ClinicalTrials.gov, last updated 2023-04-04.

Sponsored by SeaSpine, Inc. (part of Orthofix Inc.) · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Active, not recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 176 studies in Neurodegenerative Diseases with a site in United States — 45 open to participants now, 58 under way, 4 of them phase 3. Neurodegenerative Diseases · United States.

Enrollment
33rd of 54
50 · median 85
Started
2020
with 9 others
Observational
54 of 176
18 open now
Registered
94th of 176
by date

Among the 176 studies in Neurodegenerative Diseases with a site in United States, this one is the 33rd largest by enrollment of the 54 observational ones that give a count, is one of 10 that started in 2020, is one of 54 observational ones, and was the 94th registered.

Neurodegenerative Diseases

436 studies on the registry are indexed under Neurodegenerative Diseases; 143 are open to participants now.

Browse Neurodegenerative Diseases studies →

Open to participants now

45 of the 176 studies in Neurodegenerative Diseases with a site in United States are open now. Recruiting first, the newest first:

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All 45 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 101 Neurodegenerative Diseases studies recruiting now, 52 (51%) set no upper age limit and 11 (11%) stop at 75 or younger; 20 take children under 18; 49 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study summary

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

Read the detailed description

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

03

Conditions studied

  • Degenerative Conditions, Neurologic
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any condition that the Investigator determines is unacceptable
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceSeaSpine Non-Cervical Pedicle Screw Systems

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

06

What researchers measure

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.

    Time frame: 12 months post-operative

Secondary outcomes

  1. Evaluation of unanticipated adverse device effects (UADE)

    Intra or Post-Procedure UADEs

    Time frame: 12-months

07

Study locations

2 sites
  • Henry Ford
    Jackson, Michigan 49201, United States
  • OrthoNeuro
    New Albany, Ohio 43054, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2020 to primary completion in Jun 2021, 15 months.

Of 82 observational studies under Neurodegenerative Diseases, half reached primary completion within 94 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 216. This study's 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2020
First posted
Mar 9, 2020
StartActual
Mar 5, 2020
Primary completionActual
Jun 30, 2021
CompletionEst.
Jun 30, 2023
Last update
Apr 4, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04300777
Lead sponsor
SeaSpine, Inc.
Responsible party
Sponsor
First posted
Mar 9, 2020
Start date
Mar 5, 2020
Primary completion
Jun 30, 2021
Completion
Jun 30, 2023 (estimated)
Last update
Apr 4, 2023

Study contacts

Frank Vizesi, Ph.D.
study director · SeaSpine, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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