Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorSI-BONE, Inc.

About this trial

The purpose of this study is to evaluate outcomes in patients treated with iFuse INTRA Ti for chronic SI joint pain.

Eligibility criteria

Qualifiers

Age > 21 years.

Patient has chronic lower back pain (≥6 months) refractory to non-surgical care.

Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or SIJ disruption) and scheduled to be treated with INTRA Ti.

Patient has SIJ pain of at least 5 on a 0-10 numeric rating scale (NRS) prior to procedure.

Disqualifiers

ASA score 4 or 5.

Severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture.

Other known sacroiliac pathology such as: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor, infection, acute fracture.

Current diagnosis of cluneal neuralgia.

Trial design

Treatments tested in this trial

  • iFuse INTRA Ti Implant System

Treatment groups

120 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators