The purpose of this study is to evaluate outcomes in patients treated with iFuse INTRA Ti for chronic SI joint pain.
PIERCE is a prospective, multicenter, post-market observational study evaluating the safety, performance, and efficacy of iFuse INTRA Ti.
Study Type
OBSERVATIONAL
Enrollment
110
FDA-cleared implant used for fusion of the sacroiliac joint (SIJ) for SIJ dysfunction, that is a direct result of SIJ disruption and degenerative sacroiliitis.
Composite endpoint of safety and performance
The participant is considered a success if all the following criteria are met: * A ≥ 2 point improvement from baseline in SIJ pain on the target side. * Absence of device-related SAE. * Absence of SSI at index procedure.
Time frame: 6 months.
Proportion of Participants with a Serious Adverse Event (SAE)
Proportion of participants with a serious adverse event classified as probably or definitely related to the study device or procedure
Time frame: 24 months
Proportion of Participants with ≥1 Subsequent Surgical Intervention(s) (SSI)
Proportion of participants undergoing one or more SSI related to the index procedure.
Time frame: 24 months
Proportion of Treated Sides with Radiographic Evidence of Loosening
Proportion of treated sides showing signs of loosening of INTRA Ti, as evidenced by both radiolucent areas around implant plus bony reaction ("rind") near implant.
Time frame: 24 months
Proportion of Implants with Radiographic Evidence of Device Migration.
Proportion of INTRA Ti implants that show evidence of device migration.
Time frame: 24 months
Proportion of Implants with Radiographic Evidence of Device Breakage.
Proportion of INTRA Ti implants that show breakage.
Time frame: 24 months
Proportion of Participants with Radiographic Evidence of SI Joint Fusion
Radiographic fusion defined as the presence of bony apposition along the bone-implant interface at the index sacroiliac joint(s), as assessed by CT.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 months