Cervical and Lumbar FusionENTRUSTNCT03699891
Evaluation of the Fortilink IBF System With TETRAfuse Technology
An observational study of Cervical and Lumbar Fusion, run by RTI Surgical at 5 sites in United States.
Trial summary
This is a multi-center, post-market, retrospective study to collect safety and performance data for patients implanted with the Fortilink IBF System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical and Lumbar Fusion
- What is being tested?
- Fortilink IBF System with TETRAfuse Technology
- Type of treatment
- Medical device
- How many people
- 119 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Nov 2018to 15 Jan 2019
- 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: Patient must have had an attempted implant of the Fortilink IBF System
Who may be able to join
- Patient must have had an attempted implant of the Fortilink IBF System
Who cannot join
- There are no exclusion criteria
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
OrthoBethesda
Bethesda, Maryland, 20817
Florida Back Institute
Boca Raton, Florida, 33496
Spine Institute of South Florida
Delray Beach, Florida, 33484
Rocky Mountain Spine
Lone Tree, Colorado, 80124
Los Angeles Orthopedic Institute
Sherman Oaks, California, 91403
About this study
This is a multi-center, post-market, retrospective study to collect safety and performance data for patients implanted with the Fortilink IBF System.
Read the detailed description
This is a multi-center, post-market, retrospective study to collect safety and performance data for patients implanted with the Fortilink IBF System.
The study will include up to 110 patients at up to 8 US sites. All patients implanted with the Fortilink System at a site will be included in the data collection. The goal is to collect data for at least 100 subjects, but the sample size will be capped at 110 to ensure that all patients at a given site are included in the analysis.
- Conditions
- Cervical and Lumbar Fusion
- Being tested
- Fortilink IBF System with TETRAfuse Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortilink IBF System with TETRAfuse TechnologyDevice
Cervical and lumbar fusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcomes associated with use of the Fortlink System
Safety assessment includes evaluation of all adverse events or complications related to the procedure and post-operative adverse events.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start6 Nov 2018
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical and Lumbar FusionStudies 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
- Retrospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699891
- Sponsor's protocol ID
- CL1103
- Acronym
- ENTRUST
- Status last verified
- Sep 2019
- First submitted
- 5 Oct 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Fortilink IBF System With TETRAfuse Technology
- ClinicalTrials.gov ID
- NCT03699891
- Acronym / sponsor ID
- ENTRUST / CL1103
- Conditions
- Cervical and Lumbar Fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- RTI SurgicalIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 9 Oct 2018 (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.
This is a multi-center, post-market, retrospective study to collect safety and performance data for patients implanted with the Fortilink IBF System.
Detailed description
This is a multi-center, post-market, retrospective study to collect safety and performance data for patients implanted with the Fortilink IBF System.
The study will include up to 110 patients at up to 8 US sites. All patients implanted with the Fortilink System at a site will be included in the data collection. The goal is to collect data for at least 100 subjects, but the sample size will be capped at 110 to ensure that all patients at a given site are included in the analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient must have had an attempted implant of the Fortilink IBF System
Key inclusion criteria (1 listed)
- Patient must have had an attempted implant of the Fortilink IBF System
Key exclusion criteria (1 listed)
- There are no exclusion criteria
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 |
|---|---|---|
| Fortilink IBF System with TETRAfuse TechnologyCervical and lumbar fusion | Device | – |
Primary outcome
Safety outcomes associated with use of the Fortlink System
Time frame: Up to 1 year
Safety assessment includes evaluation of all adverse events or complications related to the procedure and post-operative adverse events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical and Lumbar Fusion, run by RTI Surgical at 5 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 1 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: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety outcomes associated with use of the Fortlink System (time frame: Up to 1 year). 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 2 Oct 2019.