Evaluation of the IFuse Bedrock Technique in Association with Posterior Lumbosacral Fusion with Iliac Fixation.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPolyclinique Bordeaux Nord Aquitaine
About this trial
The purpose of this study is to describe the impact of the iFuse Bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject scheduled for open posterior lumbosacral arthrodesis (including at least the following three vertebrae: L4, L5 and S1) associated with a sacroiliac fusion procedure and iliac fixation (thoracolumbar fusion procedures extended to sacrum are eligible in the study);
Insertion of at least 1 iFuse-3D implant according to the iFuse Bedrock technique (uni- and bilateral insertion are eligible);
Subject who preoperatively responded positively to pain provocation tests for SIJ dysfunction with or without a positive SIJ infiltration test;
Patient with a degenerative sacroiliac joint disease requested a fusion procedure;
Disqualifiers
Major osteoporosis (DEXA scan > 3);
Any previous history of sacroiliac joint fusion or any surgical procedure involving a S2-iliac fusion;
Subjects requested a SIJ fusion without the iFuse-3D device or iFuse-3D not inserted according to the manufacturer instruction (Bedrock technique);
Subjects with a medical or surgical contraindication preventing the intervention from being performed or potentially interfering in the interpretation of the data collected (neurologic condition, local or systemic infection, any known allergy to surgical implants, psychiatric diseases, ...);
Trial population
All participants enrolled in the study are adult subjects who underwent an open posterior lumbosacral fusion procedure with additional sacroiliac joint fusion according to the iFuse Bedrock technique (insertion of the iFUSE-3D implant). Lumbosacral fusion involved at least the following vertebrae : L4, L5 and S1.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
iFuse Bedrock technique
DeviceLumbosacral arthrodesis on 2 or more spinal segments (including at least L4, L5 and S1 vertebrae) associated with a sacroiliac fusion procedure according to the Bedrock technique using the iFuse 3D system and iliac fixation.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: iFuse Bedrock technique1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in self-reported Oswestry Disability Index (ODI) at 12 months
A decrease of 16 points in the ODI score at 12 months compared to the preoperative score is expected in order to demonstrate a 30% effecacy of the iFuse Bedrock technique in reducing postoperative pain.
Time frame
12 monthsSecondary outcomes
1
Change from baseline in sacroiliac joint pain provocation tests.
The number of positive SIJ pain provocation tests (Östgaard test, Faber test, Gaenslen test, Lasegue test, Compression, Long ligament test) performed at 3, 6 and 12 months will be compared against baseline (preoperative).
Time frame
During 12 months2
Assessment of the Oswestry Disability Index
Change from baseline in self reported Oswestry Disability Index (ODI) score at 3 and 6 months.
Time frame
3 and 6 months3
Improvement of back and leg pains at 3, 6 and 12 months compared to preoperative scores
Back and leg pain intensity self-report will be assessed before and after initial procedure for each patient (at 3, 6 and 12 months) using a 0 to 10 visual analog scale (0: no pain ; 10: most imaginable pain).
Time frame
3, 6 and 12 months4
Change in Patient's quality of life
Change from baseline in self reported 12-Item Short Form Survey (SF-12) score at 3, 6 and 12 months.
Time frame
3, 6 and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Polyclinique Bordeaux Nord Aquitaine
Lead sponsor
SI-BONE, Inc.
Collaborator
Source ClinicalTrials.gov