Sacroiliac Joint DysfunctionSIMON1NCT06909292
Sacroiliac (SI) Joint Transfixing and Fusion: Meaningful Long Term Outcomes With Nevro1
An observational study of Sacroiliac Joint Dysfunction, run by Nevro Corp at 5 sites in United States.
Trial summary
The goal of this observational study is to learn if Nevro1 Sacroiliac Transfixing and Fusion System can treat sacroiliac joint dysfunction in males or females over 21. The main questions it aims to answer is what percentage of patients have clinically important pain relief with no adverse events, and what proportion… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- Sacroiliac Joint transfixing and fusion system (Nevro1)
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Apr 2025to 21 May 2025
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort will be selected from participating clinics
Who may be able to join
- Has medical insurance that covers this standard of care procedure and all other anticipated and unanticipated procedure-related care, and all coverage criteria required by insurer are met, which may include but are not limited to:
- Has had low back and/or buttock pain for at least 6 months that is inadequately responsive to non-surgical care
- Has a positive Fortin's test
- Has a diagnosis of SIJ dysfunction (degenerative sacroiliitis or SI disruption) with pain elicited on at least 3 of 5 provocative tests (FABER, Gaenslen, Distraction, Thigh Thrust, Compression).
- At least 75% reduction in pain for the expected duration of two anesthetics (on separate visits each with a different duration of action), and the ability to perform previously painful maneuvers, following an image-guided, contrast-enhanced intra-articular (diagnostic) SIJ injection
- A trial of at least one therapeutic intra-articular SIJ injection (i.e. corticosteroid injection)
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- Has an ODI score ≥30% at enrollment
- Has a SI joint pain score of at least 5 out of 10 on numerical rating scale at enrollment.
- Be at least 21 years of age at enrollment
- The patient's physician has decided that the best treatment for the patient's SIJ dysfunction is the Nevro1 SI Fixation System, and the patient has agreed to the treatment
- Be willing and capable of giving written informed consent
- Be mentally and physically able to comply with study-related requirements and procedures and attend all scheduled visits
Who cannot join
- Has current severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, lumbar radicular pain, and lumbar vertebral body fracture
- Has SIJ pain secondary to inflammatory conditions or other known sacroiliac pathology such as: Sacral dysplasia, inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondylo-arthropathy), tumor, infection, acute fracture, and crystal arthropathy
- Has had a previous SIJ implant placement, including an allograft
- Has had an injection with corticosteroid into the index SIJ within the last 30 days
- Has had a sacral radiofrequency ablation within the last 6 months
- Has a history of recent (<1 year) major trauma to pelvis
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- Has previously diagnosed or suspected severe osteoporosis (defined as prior T-score < -2.5 or history of osteoporotic fracture)
- Has a chronic rheumatologic condition (e.g., rheumatoid arthritis)
- Has a known allergy to titanium or titanium alloys
- Has a current local or systemic infection that raises the risk of surgery
- Is currently receiving or seeking short- or long-term worker's compensation related to the SI joint or low back pain, is currently receiving disability remuneration related to SI joint or low back pain, and/or is currently involved in injury litigation related to the SI joint or low back pain
- Is participating in an investigational study or has been involved in an investigational study within 3 months prior to enrollment
- Has any condition or anatomy that makes treatment with the Nevro1 SI Fixation System infeasible
- Is taking a medication known to have detrimental effects on bone quality and soft tissue healing
- Has a prominent neurologic condition that would interfere with physical therapy
- Be pregnant or plan on becoming pregnant in the next two years.
- Has a medical condition or pain in other area(s), not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
AIRS Clinic
Lodi, California, 95240
Michigan Orthopaedic Surgeons
Southfield, Michigan, 48033
Advanced Spine and Pain Specialists
Spring, Texas, 77380
Procura Pain and Spine
The Woodlands, Texas, 77384
Carolinas Pain Institute
Winston-Salem, North Carolina, 27103
About this study
Official title: A Post-market, Multicenter, Prospective, Clinical Study to Evaluate the Nevro1 Sacroiliac (SI) Transfixing and Fusion System for the Treatment of Sacroiliac Joint Dysfunction
The goal of this observational study is to learn if Nevro1 Sacroiliac Transfixing and Fusion System can treat sacroiliac joint dysfunction in males or females over 21. The main questions it aims to answer is what percentage of patients have clinically important pain relief with no adverse events, and what proportion of patients have fusion of the sacroiliac joint at 1 year and 2 years.
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- Sacroiliac Joint transfixing and fusion system (Nevro1)
- Keywords
- Sacroiliac transfixing, sacroiliac fusion, sacroiliac joint pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacroiliac Joint transfixing and fusion system (Nevro1)Device
The Nevro1 is a titanium cage the is implanted in the sacroiliac join from a posterior direction, and then anchors are deployed that stabilize the joint. It has multiple openings to allow surgeons to fill them with autogenous bone graft to encourage bone bridging through the implant for SIJ fusion.
| Study group | Role | What they receive |
|---|---|---|
| Treated Group | Treated with Nevro1 transfixing and fusion system Receives: Device: Sacroiliac Joint transfixing and fusion system (Nevro1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Pain Relief and Safety Responder
The proportion of patient meeting the following criteria:
- NRS score for SIJ pain reduced by at least 2 points from baseline.
- Absence of implant-related serious adverse events (SAEs).
- Absence of neurologic worsening related to the lumbosacral nerve roots.
- Absence of reoperation (removal, revision reoperation or supplemental fixation) for SIJ pain.
Measured: 6 months
Secondary outcomes (6)
Change in Disability
Absolute change from baseline in Oswestry Disability Index (ODI) score. The total score ranges from 0 (minimal disability) to 100 (severe disability, e.g., bedridden).
Measured: 6 months
Patient Global Impression of Change (PGIC)
Proportion of patients reporting "Better" or "A great deal better" on the PGIC. The PGIC is a 7-point scale with responses ranging from "no change (or condition has gotten worse)" to "a great deal better".
Measured: 6 months
Physical and Mental Health Summary (PROMIS-29)
Absolute change from baseline in PROMIS-29 score. Higher scores represent greater impact of pain on a patients life in the domains of physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance.
Measured: 6 months
Change in Quality of Life
Absolute change from baseline in the index score of EuroQol 5-dimension 5 level (EQ-5D-5L) a standardized measure of health status. The index score ranges from zero to one, with one representing the highest possible health state.
Measured: 6 months
Change in Sleep Disturbance Due to Pain
Absolute change from baseline in Pain and Sleep Questionnaire Three-Item Index (PSQ-3) score. The scale ranges from 0 (pain does not affect sleep) to 30 (pain has maximum effect on sleep).
Measured: 6 months
Timed "Up and Go" Performance test (TUG)
Absolute change from baseline in time to perform the TUG.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start3 Apr 2025
- Primary completion21 May 2025
- Study completion21 May 2025
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
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevro Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rose P Azalde, MS, Study director, Nevro Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909292
- Sponsor's protocol ID
- CA2024-02 US SIJ-PM
- Acronym
- SIMON1
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study data will be reported with descriptive statistics describing group level outcomes, not individual outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market, Multicenter, Prospective, Clinical Study to Evaluate the Nevro1 Sacroiliac (SI) Transfixing and Fusion System for the Treatment of Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT06909292
- Acronym / sponsor ID
- SIMON1 / CA2024-02 US SIJ-PM
- Conditions
- Sacroiliac Joint Dysfunction
- Keywords
- Sacroiliac transfixing, sacroiliac fusion, sacroiliac joint pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Nevro CorpIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 3 Apr 2025 (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.
The goal of this observational study is to learn if Nevro1 Sacroiliac Transfixing and Fusion System can treat sacroiliac joint dysfunction in males or females over 21. The main questions it aims to answer is what percentage of patients have clinically important pain relief with no adverse events, and what proportion of patients have fusion of the sacroiliac joint at 1 year and 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated Group | – | Device: Sacroiliac Joint transfixing and fusion system (Nevro1)Treated with Nevro1 transfixing and fusion system |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort will be selected from participating clinics
Key inclusion criteria (12 listed)
- Has medical insurance that covers this standard of care procedure and all other anticipated and unanticipated procedure-related care, and all coverage criteria required by insurer are met, which may include but are not limited to:
- Has an ODI score ≥30% at enrollment
- Has a SI joint pain score of at least 5 out of 10 on numerical rating scale at enrollment.
- Be at least 21 years of age at enrollment
- The patient's physician has decided that the best treatment for the patient's SIJ dysfunction is the Nevro1 SI Fixation System, and the patient has agreed to the treatment
Key exclusion criteria (17 listed)
- Has current severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, lumbar radicular pain, and lumbar vertebral body fracture
- Has SIJ pain secondary to inflammatory conditions or other known sacroiliac pathology such as: Sacral dysplasia, inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondylo-arthropathy), tumor, infection, acute fracture, and crystal arthropathy
- Has had a previous SIJ implant placement, including an allograft
- Has had an injection with corticosteroid into the index SIJ within the last 30 days
- Has had a sacral radiofrequency ablation within the last 6 months
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 |
|---|---|---|
| Sacroiliac Joint transfixing and fusion system (Nevro1)The Nevro1 is a titanium cage the is implanted in the sacroiliac join from a posterior direction, and then anchors are deployed that stabilize the joint. It has multiple openings to allow surgeons to fill them with autogenous bone graft to encourage bone bridging through the implant for SIJ fusion. | Device | Treated Group |
Primary outcome
Composite Pain Relief and Safety Responder
Time frame: 6 months
The proportion of patient meeting the following criteria: * NRS score for SIJ pain reduced by at least 2 points from baseline. * Absence of implant-related serious adverse events (SAEs). * Absence of neurologic worsening related to the lumbosacral nerve roots. * Absence of reoperation (removal, revision reoperation or supplemental fixation) for SIJ pain.
6 secondary outcomes
Change in Disability
Time frame: 6 months
Patient Global Impression of Change (PGIC)
Time frame: 6 months
Physical and Mental Health Summary (PROMIS-29)
Time frame: 6 months
Change in Quality of Life
Time frame: 6 months
Change in Sleep Disturbance Due to Pain
Time frame: 6 months
Timed "Up and Go" Performance test (TUG)
Time frame: 6 months
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 25 Jun 2026.
- Individual participant dataSharing planned: No. Study data will be reported with descriptive statistics describing group level outcomes, not individual outcomes.
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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.
Rose P Azalde, MS study director
Nevro Corp
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 Sacroiliac Joint Dysfunction, run by Nevro Corp 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 12 inclusion and 17 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 25 Jun 2026. 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?
Composite Pain Relief and Safety Responder (time frame: 6 months). 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 25 Jun 2026.