Evaluation of the iFuse Bedrock Technique in Association With Posterior Lumbosacral Fusion With Iliac Fixation.

Spine Deformity Clinical Trial

Official title:

Evaluation of the iFuse Bedrock Technique in Association With Posterior Lumbosacral Fusion With Iliac Fixation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05276024
• Other study ID #: 2021-ORT03
• Status: Recruiting
• Start date: June 10, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: November 2023
• Source: Polyclinique Bordeaux Nord Aquitaine
• Contact: Stéphane Bourret
• Phone: +33(0)556437017
• Email: s.bourret[@]bordeauxnord.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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, ...);

• Currently pregnant or planning pregnancy;

• Prisoner or a ward of the state;

• Subject no willing to participate in the study;

• Subject not affiliated to a social security insurance.

Related Conditions & MeSH terms

• Sacroiliac; Fusion
• Sacroiliitis
• Spine Deformity

Intervention

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.

Locations

Country	Name	City	State
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	Hôpitaux Universitaires de Marseille	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Polyclinique Bordeaux Nord Aquitaine	SI-BONE, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of any serious adverse events	Record of any intra and postoperative complications	During 12 months