Degenerative SacroiliitisSIMPLIFYNCT07849244
Sacroiliac Joint Fusion Intervention For Mobility, Pain Relief, and Lasting Improvement in Functional Recovery "SIMPLIFY"
An observational study of Degenerative Sacroiliitis and Sacroiliac Disorder, run by OrthoFundamentals, LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine the clinical efficacy of The Trellis SI Joint Fusion System in unilateral sacroiliac (SI) joint fusion surgeries. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Degenerative Sacroiliitis, Sacroiliac Disorder
- What is being tested?
- TRELLIS SI Joint Fusion System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 30 Sep 2028
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Age ≥ 21 at time of screening;
- Diagnosis of unilateral sacroiliac (SI) joint dysfunction (degenerative sacroiliitis or sacroiliac disruption)
- Presence of low back/buttock pain and unresponsive to non-operative treatment for at least 6 months or has the presence of progressive symptoms in the face of conservative treatment; Oswestry Disability Index (ODI) score ≥ 30%;
- SIJ pain score ≥ 5 on 0-10 numerical rating scale (NRS);
- Ability and willingness to comply with follow-up regimen; and
- Written informed consent by the patient
Who cannot join
- Low back/buttock pain due to other causes including, but not limited to, lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degermation, or lumbar vertebral body fracture;
- Planned bilateral SI joint fixation
- Received prior SI joint fusion1;
- Cluneal neuralgia;
- Inflammatory sacroiliitis (e.g., ankylosing spondylitis, psoriatic arthritis, reactive arthritis, non-radiographical axial spondyloarthritis, inflammatory bowel disease-associated arthritis);
- Sacroiliac tumor as source of symptoms;
Show all 23Show fewer
- Sacroiliac fracture or unresolved trauma as source of symptoms;
- Anatomic anomalies/defects that in the opinion of the Investigator preclude device placement
- History of recent (<1 year) major trauma to pelvis;
- History of suspected history of severe osteoporosis (defined with a prior T-score < -2.5 or history of osteoporotic fracture);
- Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid arthritis);
- History of fibromyalgia;
- Infection at the site of surgery;
- Known or suspected allergies to titanium or titanium alloys
- Pregnant (verified in patients of childbearing potential by a negative urine pregnancy test when preadmission testing is obtained), or interested in becoming pregnant during the duration of the study;
- A body mass index (BMI) > 35;
- Currently pursuing personal litigation (defined as litigation that will likely influence the patient's ability or willingness to accurately report their treatment outcomes) related to the sacroiliac;
- Currently receiving worker's compensation related to the sacroiliac;
- Current or recent history of substance abuse (drug or alcohol) per the Investigator's determination;
- Mental conditions (e.g., schizophrenia, personality disorders) that could interfere with study participation, per the investigator's determination;
- Use of any investigational drug or medical device within the last 60 days prior to surgery;
- Tobacco and/or nicotine use within the last 60 days prior to surgery, or tobacco and/or nicotine use during the duration of the study;
- Currently a prisoner; 1Prior allograft implant is acceptable and not exclusionary
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northwest Specialty Hospital
Post Falls, Idaho, 83854
About this study
The purpose of this study is to determine the clinical efficacy of The Trellis SI Joint Fusion System in unilateral sacroiliac (SI) joint fusion surgeries.
Read the detailed description
This multi-center, post-market, prospective clinical study evaluates patients identified by the Investigator in their practice. The purpose of this study is to determine the clinical efficacy of The Trellis SI Joint Fusion System in unilateral sacroiliac (SI) joint fusion surgeries.
- Conditions
- Degenerative Sacroiliitis, Sacroiliac Disorder
- Being tested
- TRELLIS SI Joint Fusion System
- Keywords
- degenerative sacroiliitis, sacroiliac disruption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRELLIS SI Joint Fusion SystemDevice
TRELLIS SI Joint Fusion System
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Evaluation through Computed Tomography (CT) Scan
Fusion evaluation through computed tomography (CT) scan at 18-month post operatively. Device placement will be confirmed by an Independent Radiologist using radiographic endpoints of the proportion of subjects who show at least 30% apposition of bone to both the iliac and sacral sides of at least 1 implant(s).
Measured: 18 months
Bridging Bone
Bridging bone across the sacroiliac joint will be assessed as continuous bridging across the treated joint, occurring either adjacent to implants, distant from implants and/or adjacent/ distant from implants, degree of bridging (<5% of joint, 5-15%, 15-30%, or 30-100%), signs of both positive and/ or adverse bone remodeling.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative SacroiliitisStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrthoFundamentals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849244
- Sponsor's protocol ID
- PM-413
- Acronym
- SIMPLIFY
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacroiliac Joint Fusion Intervention For Mobility, Pain Relief, and Lasting Improvement in Functional Recovery "SIMPLIFY"
- ClinicalTrials.gov ID
- NCT07849244
- Acronym / sponsor ID
- SIMPLIFY / PM-413
- Conditions
- Degenerative Sacroiliitis, Sacroiliac Disorder
- Keywords
- degenerative sacroiliitis, sacroiliac disruption
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- OrthoFundamentals, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 30 Sep 2026 (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 purpose of this study is to determine the clinical efficacy of The Trellis SI Joint Fusion System in unilateral sacroiliac (SI) joint fusion surgeries.
Detailed description
This multi-center, post-market, prospective clinical study evaluates patients identified by the Investigator in their practice. The purpose of this study is to determine the clinical efficacy of The Trellis SI Joint Fusion System in unilateral sacroiliac (SI) joint fusion surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (6 listed)
- Age ≥ 21 at time of screening;
- Diagnosis of unilateral sacroiliac (SI) joint dysfunction (degenerative sacroiliitis or sacroiliac disruption)
- Presence of low back/buttock pain and unresponsive to non-operative treatment for at least 6 months or has the presence of progressive symptoms in the face of conservative treatment; Oswestry Disability Index (ODI) score ≥ 30%;
- SIJ pain score ≥ 5 on 0-10 numerical rating scale (NRS);
- Ability and willingness to comply with follow-up regimen; and
Key exclusion criteria (23 listed)
- Low back/buttock pain due to other causes including, but not limited to, lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degermation, or lumbar vertebral body fracture;
- Planned bilateral SI joint fixation
- Received prior SI joint fusion1;
- Cluneal neuralgia;
- Inflammatory sacroiliitis (e.g., ankylosing spondylitis, psoriatic arthritis, reactive arthritis, non-radiographical axial spondyloarthritis, inflammatory bowel disease-associated arthritis);
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 |
|---|---|---|
| TRELLIS SI Joint Fusion SystemTRELLIS SI Joint Fusion System | Device | – |
Primary outcome
Fusion Evaluation through Computed Tomography (CT) Scan
Time frame: 18 months
Fusion evaluation through computed tomography (CT) scan at 18-month post operatively. Device placement will be confirmed by an Independent Radiologist using radiographic endpoints of the proportion of subjects who show at least 30% apposition of bone to both the iliac and sacral sides of at least 1 implant(s).
Bridging Bone
Time frame: 18 months
Bridging bone across the sacroiliac joint will be assessed as continuous bridging across the treated joint, occurring either adjacent to implants, distant from implants and/or adjacent/ distant from implants, degree of bridging (<5% of joint, 5-15%, 15-30%, or 30-100%), signs of both positive and/ or adverse bone remodeling.
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 30 Sep 2026.
- Individual participant dataSharing planned: No. IPD will not be shared
Related trials for Degenerative Sacroiliitis
Not yet recruitingObservational study
Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes
Sacro Iliac Joint Pain, Sacro-iliac Joints
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Degenerative Sacroiliitis and Sacroiliac Disorder, run by OrthoFundamentals, LLC 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 6 inclusion and 23 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 30 Sep 2026. 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?
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?
Fusion Evaluation through Computed Tomography (CT) Scan (time frame: 18 months). The study lists 2 primary outcomes in all. 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 30 Sep 2026.