A Multicenter, Retrospective Evaluation of The Efficacy of a Novel Posterior Sacroiliac Joint Fusion System: Initial Case Series

Author(s): Robert E. Tibbs Jr., Ankur Khosla, Jonathan Grossman, Joseph Savino

Background:

The advent of minimally invasive techniques has significantly advanced sacroiliac joint (SIJ) fusion procedures. Previous studies have reported improvements in pain and functional improvement using Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI) following SIJ fusion. Clinical outcomes have been modest, with some patients not achieving the Minimal Clinically Important Difference (MCID) in pain and functional improvement with respect to certain techniques and approaches. The TiLink-P®, SIJ fusion implant is a novel 3D-printed titanium implant with an advanced surface technology designed to improve patient outcomes in SIJ fusion via a posterior approach. This study aimed to assess the efficacy of the TiLink-P® Minimally Invasive SIJ fusion procedure and implant in a case series.

Methods:

A multicenter retrospective analysis included four US sites. Patients who were previously treated with TiLink-P® between October 1, 2023 to January 4, 2024, were consecutively screened for eligibility. De-identified demographic data, preoperative pain, disability scores, and postoperative outcomes at approximately one year were collected. The primary outcome measures were changes in pain using NRS (Numeric Rating Scale) or VAS and disability using ODI from preoperative to approximately one-year postoperative.

Results:

A total of 21 subjects were included for analysis with a mean age of 66.6 years, and a mean BMI of 32.1 . The mean follow-up period was 11.6 months. Compared to the preoperative values, the follow up back pain score (VAS) and ODI values improved 60.3%, from 83.3 to 31.1 (p < 0.0001) and 71.9% from 52.8 to 8.3 (p = 0.001) respectively.

Clinical Relevance:

There were no device or procedure events during the study period. Pain and ODI scores were statistically improved at approximately 1 year follow-up.

Conclusions/Level of Evidence:

The TiLink-P® posterior SIJ fusion system demonstrated significant pain reduction and functional improvement scores without procedure or device-related adverse events.