Sacroiliac Joint DysfunctionRELIEFNCT06487936
Real-World Registry Study on Patient Satisfaction With TransLoc 3D SI Joint Fusion
An observational study of Sacroiliac Joint Dysfunction and Sacroiliac; Fusion, run by CornerLoc at 1 site in United States.
Trial summary
This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliac Joint Dysfunction, Sacroiliac; Fusion
- What is being tested?
- TransLoc 3D SI Joint Fusion System
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 15 Dec 2024
- How long will I take part?
- 18 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have already received the TransLoc 3D System > 1 year postoperatively < 18 months, at the time of consent.
Who may be able to join
- Age 18 year or older
- Confirmed Implant of the Transloc 3D Fusion System
- Did not have Transloc device removed or another manufacturer device implanted post Transloc
- Does not have other manufacturer's titanium or metal implant
- Patient may be included with prior allograft implant
- Willing to participate and give written consent
- Must have or planned CT post ≥1 year per standard of care
Who cannot join
- Patient is younger than 18 years
- Patient is unable to sign the Informed Consent
- Implant of other manufacturer's titanium or alternative metal implant
- Revision with another manufacturer's implant
- Fracture or unresolved trauma of implant side after implantation of TransLoc
- Patient unwilling to participate in Patient Satisfaction Survey
- Patient has not returned for Standard of Care follow-up
Trial locations and contacts
1 site in 1 country.
Bob Compton contact
United States1 site, 1 recruiting
- Recruiting
Advanced Orthopedic Center
Port Charlotte, Florida, 33948
Lee James, DO
About this study
Official title: A Multi-Center, Real World Prospective/Retrospective Registry to Evaluate Patient Satisfaction With the TransLoc 3D SI Joint Fusion System
This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.
- Conditions
- Sacroiliac Joint Dysfunction, Sacroiliac; Fusion
- Being tested
- TransLoc 3D SI Joint Fusion System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransLoc 3D SI Joint Fusion SystemDevice
Satisfaction survey will be administered to collect real world evidence on patients that previously received the TransLoc 3D System commercially.
| Study group | Role | What they receive |
|---|---|---|
| Implanted TransLoc 3D SIJ Fusion Patients | Patients who were diagnosed with sacroiliitis and were treated with the TransLoc 3D System ≥ 1 year ≤ 18 months at the time of consent. Receives: Device: TransLoc 3D SI Joint Fusion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Survey
Patient satisfaction survey administered greater than 1 year post-op: satisfaction, functional improvement, and disability as it relates to their SI joint
Measured: Prospective 12 to 18 months post surgery
Secondary outcomes (4)
Visual Analogue Scale (VAS) of pain
Retrospective analysis of VAS pre and post surgery, if available
Measured: Baseline up to 1 year post surgery
Oswestry Disability Index (ODI)
Retrospective analysis of ODI pre and post surgery, if available
Measured: Baseline up to 1 year post surgery
SAEs
Retrospective capture of Serious Adverse Events (SAEs) from the time of SI Fusion up to 90 days post operatively that required re-operation or in-patient hospitalization.
Measured: Time of surgery up to 90 days post surgery
CT Scan Second Read (Radiological Overread)
CT scan for placement and fusion
Measured: 12 to 18 months post fusion surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start15 Aug 2024
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies 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
- Other
- Enrolment
- 120 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- CornerLoc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lee James, DO, Principal investigator, Advanced Orthopedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487936
- Sponsor's protocol ID
- RELIEF-02-24
- Acronym
- RELIEF
- Status last verified
- Aug 2024
- First submitted
- 24 Jun 2024
- Last updated
- 23 Aug 2024
- 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Real World Prospective/Retrospective Registry to Evaluate Patient Satisfaction With the TransLoc 3D SI Joint Fusion System
- ClinicalTrials.gov ID
- NCT06487936
- Acronym / sponsor ID
- RELIEF / RELIEF-02-24
- Conditions
- Sacroiliac Joint Dysfunction, Sacroiliac; Fusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- CornerLocIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 5 Jul 2024 (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, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted TransLoc 3D SIJ Fusion Patients | – | Device: TransLoc 3D SI Joint Fusion SystemPatients who were diagnosed with sacroiliitis and were treated with the TransLoc 3D System ≥ 1 year ≤ 18 months at the time of consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have already received the TransLoc 3D System > 1 year postoperatively < 18 months, at the time of consent.
Key inclusion criteria (7 listed)
- Age 18 year or older
- Confirmed Implant of the Transloc 3D Fusion System
- Did not have Transloc device removed or another manufacturer device implanted post Transloc
- Does not have other manufacturer's titanium or metal implant
- Patient may be included with prior allograft implant
Key exclusion criteria (7 listed)
- Patient is younger than 18 years
- Patient is unable to sign the Informed Consent
- Implant of other manufacturer's titanium or alternative metal implant
- Revision with another manufacturer's implant
- Fracture or unresolved trauma of implant side after implantation of TransLoc
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 |
|---|---|---|
| TransLoc 3D SI Joint Fusion SystemSatisfaction survey will be administered to collect real world evidence on patients that previously received the TransLoc 3D System commercially. | Device | Implanted TransLoc 3D SIJ Fusion Patients |
Primary outcome
Patient Satisfaction Survey
Time frame: Prospective 12 to 18 months post surgery
Patient satisfaction survey administered greater than 1 year post-op: satisfaction, functional improvement, and disability as it relates to their SI joint
4 secondary outcomes
Visual Analogue Scale (VAS) of pain
Time frame: Baseline up to 1 year post surgery
Oswestry Disability Index (ODI)
Time frame: Baseline up to 1 year post surgery
SAEs
Time frame: Time of surgery up to 90 days post surgery
CT Scan Second Read (Radiological Overread)
Time frame: 12 to 18 months post fusion surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- 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.
Bob Compton contact
Lee James, DO principal investigator
Advanced Orthopedic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacroiliac Joint Dysfunction and Sacroiliac; Fusion, run by CornerLoc at 1 site 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 7 inclusion and 7 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 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Carley Wiegner (888-743-8736, carley@cornerloc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction Survey (time frame: Prospective 12 to 18 months post surgery). 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 23 Aug 2024.