iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction (STACI) is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.
This trial is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system. The goal of the trial is to demonstrate the effectiveness of the device for its intended use.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Use of iFuse TORQ for the treatment of SI Joint dysfunction
Napa Valley Orthopaedics
Napa, California, United States
Source Healthcare
Santa Monica, California, United States
Comprehensive Pain and Spine Specialists
Shelbyville, Indiana, United States
Change in SI joint pain measured by numerical rating scale (NRS)
Change in SI joint pain measured by NRS (0- no pain to 10- worst pain imaginable)
Time frame: At baseline and 6 months
Improvement from baseline in SI joint (SIJ) pain
Improvement from baseline in SIJ pain as measured by numeric rating scale (0- no pain to 10- worst pain imaginable).
Time frame: At baseline, 1-, 3-, 6-, 12-, and 24-months
Improvement from baseline in disability
Improvement from baseline in disability as measured by Oswestry Disability Index
Time frame: At baseline, 1-, 3-, 6-, 12-, and 24-months
Improvement from baseline in quality of life
Improvement from baseline in aggregate quality of life and individual domains as measured by PROMIS-29.
Time frame: At baseline, 1-, 3-, 6-, 12-, and 24-months
Proportion of subjects with a complication rated as probably or definitely related to the procedure or device.
Time frame: At baseline, 1-, 3-, 6-, 12-, and 24-months
Evidence of bone binding
Evidence of bone binding to at least 50% of the porous surface area of each implanted device
Time frame: At baseline and 24 months
Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation
Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation, as evidenced by both radiopaque areas around implant plus bony reaction ("rind") near implant
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Ascentist Healthcare
Leawood, Kansas, United States
Crimson Pain Management
Overland Park, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Clearway Pain
Annapolis, Maryland, United States
St Louis Pain Consultants
Chesterfield, Missouri, United States
Nevada Advanced Pain
Reno, Nevada, United States
Clinical Investigations
Edmond, Oklahoma, United States
...and 4 more locations
Time frame: At baseline and 24 months
Proportion of iFuse TORQ implants that show evidence of device migration
Time frame: At baseline and 24 months
Proportion of iFuse TORQ implants that show breakage
Time frame: At baseline and 24 months