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

NCT07849244 | Enrolling By Invitation FDA Device

• 1 other identifier: PM-413
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Sacroiliitis; Sacroiliac Disorder

Keywords

degenerative sacroiliitis; sacroiliac disruption

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  18 months

Interventions

TRELLIS SI Joint Fusion System DEVICE

TRELLIS SI Joint Fusion System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• OrthoFundamentals, LLC: lead

Study Sites (1)

Northwest Specialty Hospital

Post Falls, Idaho, 83854, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 30, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)