An observational study in Sacroiliitis, Sacroiliac; Fusion and Lumbosacral; Fusion, sponsored by Polyclinique Bordeaux Nord Aquitaine. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Polyclinique Bordeaux Nord Aquitaine · Observational
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.
This study is a multicentric, post-marked clinical investigation to assess the efficacy of the iFuse Bedrock technique to avoid post-operative pains in patients who underwent open posterior multilevel lumbosacral fusion. Subjects will be monitored for lumbar pains (Oswestry score, VAS, SF-12 questionnaire) and sacroiliac joint pains (provocative tests) up to 12 months after initial procedure. A single CT-scan acquisition will be performed at 12 months to detect any iFuse system-related abnormality (implants loosening or breakages).
42 studies on the registry are indexed under Sacroiliitis; 11 are open to participants now.
This study's enrollment of 48 is below the median of 120 across 13 observational studies indexed under Sacroiliitis.
Browse Sacroiliitis studies →Polyclinique Bordeaux Nord Aquitaine is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Multilevel lumbar fusion procedure with additional sacroiliac joint stabilization using the iFuse-3D system
Device: iFuse Bedrock technique
Lumbosacral 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.
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 months
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 months
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 months
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 months
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 months
Proportion of subjects with postoperative SIJ fusion failure
Proportion of subjects with SIJ fusion failure on CT scan as interpreted by the investigator
Time frame: 12 months
Impact of iFuse Bedrock technique on Pelvic Incidence
Measurement of postoperative Pelvic Incidence (PI) using EOS stereography at 3, 6 and 12 months compared to baseline. Pelvic Incidence is the angle between the line perpendicular to the S1 endplate from the midpoint of the endplate and the connecting line from the midpoint of the S1 endplate to center of the femoral head.
Time frame: During 12 months
Impact of iFuse Bedrock technique on Pelvic Tilt
Measurement of postoperative Pelvic Tilt (PT) using EOS stereography at 3, 6 and 12 months compared to baseline. Pelvic Tilt is the angle between the connecting line from the midpoint of the S1 endplate to the center of the femoral head and the vertical line.
Time frame: During 12 months
Impact of iFuse Bedrock technique on Sacral Slope
Measurement of postoperative Sacral Slope (SS) using EOS stereography at 3, 6 and 12 months compared to baseline. Sacral Slope is the angle between the tangent and the horizontal line of S1 endplate.
Time frame: During 12 months
Impact of iFuse Bedrock technique on Lumbar Lordosis
Measurement of postoperative Lumbar Lordosis (LL) using EOS stereography at 3, 6 and 12 months compared to baseline. Lumbar Lordosis is the angle between the L1 upper endplate and the S1 upper endplate.
Time frame: During 12 months
Impact of iFuse Bedrock technique on Thoracic Kyphosis
Measurement of postoperative Thoracic Kyphosis (TK) using EOS stereography at 3, 6 and 12 months compared to baseline. Thoracic Kyphosis is the angle between the T4 upper endplate and the T12 lower endplate.
Time frame: During 12 months
Impact of iFuse Bedrock technique on the Odontoid Hip Axis
Measurement of postoperative Odontoid Hip Axis (OD-HA) using EOS stereography at 3, 6 and 12 months compared to baseline. Odontoid Hip Axis is the angle between the vertical and the highest point of the odontoid process (dens) connecting to the centre of the acetabulum (bi-coxo-femoral axis)
Time frame: During 12 months
Impact of iFuse Bedrock technique on the T1 pelvic angle
Measurement of postoperative T1 pelvic angle (TPA) using EOS stereography at 3, 6 and 12 months compared to baseline. TPA is the angle between the line from centroid of T1 to the femoral head axis and the line from femoral head axis to middle of the S1 endplate
Time frame: During 12 months
Proportion of subjects with iFuse-3D implant-related complications
Proportion of subjects with any of the following complications related to the iFuse-3D implant : malposition of the implant (intra-operative evaluation), loosening, displacement, abnormal bone reaction, breakage or any other complication directly related to the insertion or use of the iFuse-3D implant.
Time frame: 12 months
Incidence of any serious adverse events
Record of any intra and postoperative complications
Time frame: During 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2022 to primary completion in Apr 2026, 45 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Polyclinique Bordeaux Nord Aquitaine