CClinicalTrials.gg
Enrolling by invitationNCT07849244SIMPLIFYUpdated Sep 30, 2026

Sacroiliac Joint Fusion Intervention For Mobility, Pain Relief, and Lasting Improvement in Functional Recovery "SIMPLIFY"

An observational study in Degenerative Sacroiliitis and Sacroiliac Disorder, sponsored by OrthoFundamentals, LLC. Enrolling by invitation at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by OrthoFundamentals, LLC · Observational

Updated Sep 30, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
21 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Degenerative Sacroiliitis
  • Sacroiliac Disorder

Keywords

  • degenerative sacroiliitis
  • sacroiliac disruption
03

In context

Lead sponsor

This is the only study on the registry with OrthoFundamentals, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic

Inclusion criteria

  1. Age ≥ 21 at time of screening;
  2. Diagnosis of unilateral sacroiliac (SI) joint dysfunction (degenerative sacroiliitis or sacroiliac disruption)
  3. 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%;
  4. SIJ pain score ≥ 5 on 0-10 numerical rating scale (NRS);
  5. Ability and willingness to comply with follow-up regimen; and
  6. Written informed consent by the patient

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. Planned bilateral SI joint fixation
  3. Received prior SI joint fusion1;
  4. Cluneal neuralgia;
  5. Inflammatory sacroiliitis (e.g., ankylosing spondylitis, psoriatic arthritis, reactive arthritis, non-radiographical axial spondyloarthritis, inflammatory bowel disease-associated arthritis);
  6. Sacroiliac tumor as source of symptoms;
  7. Sacroiliac fracture or unresolved trauma as source of symptoms;
  8. Anatomic anomalies/defects that in the opinion of the Investigator preclude device placement
  9. History of recent (\<1 year) major trauma to pelvis;
  10. History of suspected history of severe osteoporosis (defined with a prior T-score \< -2.5 or history of osteoporotic fracture);
  11. Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid arthritis);
  12. History of fibromyalgia;
  13. Infection at the site of surgery;
  14. Known or suspected allergies to titanium or titanium alloys
  15. 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;
  16. A body mass index (BMI) > 35;
  17. 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;
  18. Currently receiving worker's compensation related to the sacroiliac;
  19. Current or recent history of substance abuse (drug or alcohol) per the Investigator's determination;
  20. Mental conditions (e.g., schizophrenia, personality disorders) that could interfere with study participation, per the investigator's determination;
  21. Use of any investigational drug or medical device within the last 60 days prior to surgery;
  22. 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;
  23. Currently a prisoner; 1Prior allograft implant is acceptable and not exclusionary
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • DeviceTRELLIS SI Joint Fusion System

    TRELLIS SI Joint Fusion System

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 18 months

  2. 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.

    Time frame: 18 months

07

Study locations

1 site
  • Northwest Specialty Hospital
    Post Falls, Idaho 83854, United States
08

References and documents

Individual participant data

Plan to share: No — IPD will not be shared

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07849244
Lead sponsor
OrthoFundamentals, LLC
Responsible party
Sponsor
First posted
Sep 30, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Sep 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion