Sacroiliac Joint Disruption Clinical Trial
Official title:
INSITE Investigation of Sacroiliac Fusion Treatment
The purpose of this study is to compare outcomes when patients with degenerative sacroiliitis (arthritis of the SI joint) and or sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint)undergo either SI joint fusion with the iFuse Implant System or undergo specific, targeted non-surgical treatment of the SI joint.
The intended analysis was to examine differences in responses at 6 months. It was acknowledged that subjects with chronic pain in the NSM arm group might not experience any benefit as there was little evidence at the time that NSM was helpful. The protocol included optional crossover to other treatments, including surgical treatment. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02270203 -
LOIS: Long-Term Follow-Up in INSITE/SIFI
|
||
| Recruiting |
NCT05633888 -
Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System
|
N/A | |
| Enrolling by invitation |
NCT05628142 -
Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study
|
N/A | |
| Active, not recruiting |
NCT04062630 -
SI Joint Stabilization in Long Fusion to the Pelvis
|
N/A | |
| Active, not recruiting |
NCT01640353 -
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
|
Phase 4 |