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| Name | Class |
|---|---|
| SI-BONE, Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iFuse Bedrock technique | Multilevel lumbar fusion procedure with additional sacroiliac joint stabilization using the iFuse-3D system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iFuse Bedrock technique | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stéphane Bourret | Contact | +33(0)556437017 | s.bourret@bordeauxnord.com | |
| Lisa Boue | Contact | +33(0)556437017 | l.boue@bordeauxnord.com |
| Name | Affiliation | Role |
|---|---|---|
| Jean Charles Le Huec, M.D., PhD | VERTEBRA Institute, Polyclinique Bordeaux Nord Aquitaine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinique Bordeaux Nord Aquitaine | Recruiting | Bordeaux | 33300 | France |
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| Assessment of the Oswestry Disability Index |
Change from baseline in self reported Oswestry Disability Index (ODI) score at 3 and 6 months. |
| 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). | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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) | 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 | 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. | 12 months |
| Incidence of any serious adverse events | Record of any intra and postoperative complications | During 12 months |
| Hôpitaux Universitaires de Marseille | Recruiting | Marseille | 13005 | France |
|
| ID | Term |
|---|---|
| D058566 | Sacroiliitis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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