Spinal DiseaseNCT04364295
Stronger Together Global Registry
An observational study of Spinal Disease, run by SeaSpine, Inc. at 2 sites in United States.
Trial summary
A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Disease
- What is being tested?
- Spinal Surgery with SeaSpine product
- Type of treatment
- Medical device
- How many people
- 2,285 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Mar 2020to Aug 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Approximately 2285 patients who were previously implanted with SeaSpine products
Who may be able to join
- Have been treated with at least one SeaSpine product.
- Have obtained radiographic imaging, as part of the standard of care, at the following time points: preoperative and postoperative.
- Have obtained at least one preoperative patient-reported outcome measure, as part of the standard of care.
- Patient is planned, per standard of care, to be assessed with radiographic imaging and consistent patient-reported outcome measure(s) from preoperative through at least two scheduled follow-up visits.
Who cannot join
- Was not implanted with at least one SeaSpine product during operation
- Any other condition that the Investigator determines is unacceptable for enrollment into this registry
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Spine Colorado
Durango, Colorado, 81301
OrthoNeuro
New Albany, Ohio, 43054
About this study
Official title: Evaluating Real-World Spine Outcomes for Spinal and Orthobiologics Products From Around the World
A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.
Read the detailed description
To gain observational, prospective, real-world clinical, and radiographic data in order to evaluate continued safety and performance following the implantation of SeaSpine products.
- Conditions
- Spinal Disease
- Being tested
- Spinal Surgery with SeaSpine product
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Surgery with SeaSpine productDevice
Implanted with SeaSpine spinal or orthobiologic product
| Study group | Role | What they receive |
|---|---|---|
| Implanted with SeaSpine spinal or orthobiologics product | Standard of Care Registry- Patients must have been implanted with at least one SeaSpine product Receives: Device: Spinal Surgery with SeaSpine product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of product failure
Product failure is defined as product fracture, loosening, gross migration and/or dissociation.
Measured: 12 months post-operative
Secondary outcomes (1)
Incidence of product-related Serious Adverse Events (SAEs) related to the spine, fusion or bone healing, and intraoperative and postoperative unanticipated adverse device effects
Product-related SAEs related to the spine, fusion, or bone will be collected for this outcome measure.
Measured: Intra-operative to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start20 Mar 2020
- Primary completionFeb 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies 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
- 2,285 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- SeaSpine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Vizesi, PhD, Study director, SeaSpine Orthopedics Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364295
- Sponsor's protocol ID
- SS-GR-1902
- Status last verified
- Mar 2023
- First submitted
- 23 Apr 2020
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
- Evaluating Real-World Spine Outcomes for Spinal and Orthobiologics Products From Around the World
- ClinicalTrials.gov ID
- NCT04364295
- Acronym / sponsor ID
- SS-GR-1902
- Conditions
- Spinal Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,285 participants (estimated)
- Lead sponsor
- SeaSpine, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 28 Apr 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.
A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.
Detailed description
To gain observational, prospective, real-world clinical, and radiographic data in order to evaluate continued safety and performance following the implantation of SeaSpine products.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted with SeaSpine spinal or orthobiologics product | – | Device: Spinal Surgery with SeaSpine productStandard of Care Registry- Patients must have been implanted with at least one SeaSpine product |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 2285 patients who were previously implanted with SeaSpine products
Key inclusion criteria (4 listed)
- Have been treated with at least one SeaSpine product.
- Have obtained radiographic imaging, as part of the standard of care, at the following time points: preoperative and postoperative.
- Have obtained at least one preoperative patient-reported outcome measure, as part of the standard of care.
- Patient is planned, per standard of care, to be assessed with radiographic imaging and consistent patient-reported outcome measure(s) from preoperative through at least two scheduled follow-up visits.
Key exclusion criteria (2 listed)
- Was not implanted with at least one SeaSpine product during operation
- Any other condition that the Investigator determines is unacceptable for enrollment into this registry
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 |
|---|---|---|
| Spinal Surgery with SeaSpine productImplanted with SeaSpine spinal or orthobiologic product | Device | Implanted with SeaSpine spinal or orthobiologics product |
Primary outcome
Evaluation of product failure
Time frame: 12 months post-operative
Product failure is defined as product fracture, loosening, gross migration and/or dissociation.
1 secondary outcome
Incidence of product-related Serious Adverse Events (SAEs) related to the spine, fusion or bone healing, and intraoperative and postoperative unanticipated adverse device effects
Time frame: Intra-operative to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Frank Vizesi, PhD study director
SeaSpine Orthopedics Corporation
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 Spinal Disease, 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 4 inclusion and 2 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: enrolling by invitation, 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?
This study is still under way. Results are not available in the source record yet.
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?
Evaluation of product failure (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.