The purpose of this study is to compare outcomes when patients with chronic sacroiliac joint pain undergo either SI joint fusion with the iFuse Implant System or undergo conservative management of the SI joint
This study is a multicenter randomized controlled, post-market clinical follow-up clinical trial of the iFuse Implant System for SI joint fusion vs. conservative management. Subjects assigned to conservative management may cross over to iFuse after a minimum of 6 months of conservative treatment. Conservative management does not include interventional procedures such as prolotherapy, steroid injections and/or RF ablation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Placement of iFuse implant system via surgery
Medications for pain, physical therapy, cognitive behavour therapy
OLV Ziekenhuis Aalst
Aalst, Belgium
La Clinique de l'Espérance
Montegnée, Belgium
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
The change in lower back pain as rated by the study subject using a 0-100 visual analog scale (VAS) at 6 months after initiation of treatment
Time frame: 6 months
Change from baseline in lower back pain (VAS)
Time frame: 1, 3, 12 and 24 months
Change from baseline in leg pain (VAS
Time frame: 1, 3, 6, 12 and 24 months
Change in disability due to back pain (ODI
Time frame: 3, 6, 12 and 24 months
Change in quality of life (EQ-5D
Time frame: 3, 6, 12 and 24 months
Change in ambulatory and work status
Time frame: 1, 3, 6, 12 and 24 months
Change in depression score (Zung Depression Scale
Time frame: 3, 6, 12 and 24 months
Change in objective functional test (ASLR
Time frame: 3, 6, 12 and 24 months
Change in walking distance
Time frame: 3, 6, 12 and 24 months
Patient satisfaction and self-rating of disease state
Time frame: 3, 6, 12 and 24 months
Serious adverse events
Time frame: during 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Praxisgemeinschaft "Leben in Bewegung"
Hilden, Germany
Istituto Ortopedico Rizzoli
Bologna, Italy
Ospedale Civile Di Legnano
Legnano, Italy
IRCCS Policlinico San Matteo
Pavia, Italy
Aleris Specialistvård Ängelholm, Ortopedkliniken
Ängelholm, Sweden
Device breakage, loosening and migration
Time frame: 12 months