Degenerative Conditions, NeurologicNCT04300777
The Fixation Study
An observational study of Degenerative Conditions, Neurologic, run by SeaSpine, Inc. at 2 sites in United States.
Trial summary
To perform a clinical evaluation of safety and performance for the SeaSpine Non- Cervical Pedicle Screw Systems Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Conditions, Neurologic
- What is being tested?
- SeaSpine Non-Cervical Pedicle Screw Systems
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Mar 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have been implanted with a SeaSpine Non-Cervical Pedicle Screw System
Who may be able to join
- Have undergone surgery
- Have undergone at least 12-months of postoperative follow-up
Who cannot join
- Any condition that the Investigator determines is unacceptable
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Henry Ford
Jackson, Michigan, 49201
OrthoNeuro
New Albany, Ohio, 43054
About this study
Official title: 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
Read the detailed description
A multi-center, post-market, clinical evaluation for subjects implanted with the SeaSpine Non-Cervical Pedicle Screw Systems
- Conditions
- Degenerative Conditions, Neurologic
- Being tested
- SeaSpine Non-Cervical Pedicle Screw Systems
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeaSpine Non-Cervical Pedicle Screw SystemsDevice
Any patient treated with a SeaSpine Non-Cervical Pedicle Screw System
| Study group | Role | What they receive |
|---|---|---|
| Treated with Non-Cervical Pedicle Screw Systems | 50 patients who have been implanted with SeaSpine Non-Cervical Pedicle Screw Systems Receives: Device: SeaSpine Non-Cervical Pedicle Screw Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-operative
Secondary outcomes (1)
Evaluation of unanticipated adverse device effects (UADE)
Intra or Post-Procedure UADEs
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start5 Mar 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Conditions, NeurologicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- SeaSpine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Vizesi, Ph.D., Study director, SeaSpine, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300777
- Sponsor's protocol ID
- SS-PMCF-1905
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2020
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the SeaSpine Non-Cervical Pedicle Screw Systems
- ClinicalTrials.gov ID
- NCT04300777
- Acronym / sponsor ID
- SS-PMCF-1905
- Conditions
- Degenerative Conditions, Neurologic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SeaSpine, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated with Non-Cervical Pedicle Screw Systems | – | Device: SeaSpine Non-Cervical Pedicle Screw Systems50 patients who have been implanted with SeaSpine Non-Cervical Pedicle Screw Systems |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have been implanted with a SeaSpine Non-Cervical Pedicle Screw System
Key inclusion criteria (2 listed)
- Have undergone surgery
- Have undergone at least 12-months of postoperative follow-up
Key exclusion criteria (1 listed)
- Any condition that the Investigator determines is unacceptable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeaSpine Non-Cervical Pedicle Screw SystemsAny patient treated with a SeaSpine Non-Cervical Pedicle Screw System | Device | Treated with Non-Cervical Pedicle Screw Systems |
Primary outcome
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.
1 secondary outcome
Evaluation of unanticipated adverse device effects (UADE)
Time frame: 12-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
Related trials for Degenerative Conditions, Neurologic
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
Active, not recruitingObservational study
A Study of the Safety of Nusinersen (Spinraza®) and Its Effects on Motor Function in Koreans Living With SMA Treated During Their Usual Medical Care
Muscular Atrophy, Spinal
RecruitingObservational study
Natural History Evaluation of Charcot Marie Tooth Disease (CMT) Types CMT1B, CMT2A, CMT4A, CMT4C, and Others
Charcot Marie Tooth Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Vizesi, Ph.D. study director
SeaSpine, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Conditions, Neurologic, run by SeaSpine, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome for the study is device performance. (time frame: 12 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.