Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants

Area of Science:

• Orthopedic Surgery
• Biomedical Engineering
• Spine Surgery

Background:

• Chronic sacroiliac joint (SIJ) dysfunction is a significant source of pain and disability.
• Minimally invasive SIJ fusion using triangular titanium implants (TTI) is an established treatment.
• Evaluating novel implant designs is crucial for improving patient outcomes.

Observation:

• A prospective multicenter trial assessed SIJ fusion (SIJF) using a 3D-printed TTI in 51 subjects.
• Patients reported outcomes via validated questionnaires and underwent functional testing and pelvic CT scans.
• Data were collected at baseline and at 3, 6, and 12 months postoperatively.

Findings:

• Significant improvements were observed in pain (VAS SIJ pain from 78 to 21) and disability (Oswestry Disability Index from 52.8 to 27.9) at 12 months (p<.0001).
• 96% of subjects experienced substantial pain relief, and physical activity limitations decreased.
• Radiographic evidence showed high rates of bone bridging (77% at 12 months), with no device failures.

Implications:

• 3D-printed TTI is a safe and effective option for SIJ fusion, comparable to traditional milled implants.
• The novel implant may promote faster bony fusion, potentially leading to quicker recovery.
• Improved outcomes and reduced opioid use highlight the clinical benefit of this technology.