Evaluation of the IFuse Bedrock Technique in Association with Posterior Lumbosacral Fusion with Iliac Fixation.

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.

Study Overview

• Status: Recruiting
• Conditions: Sacroiliitis; Spine Deformity; Sacroiliac; Fusion; Lumbosacral; Fusion
• Intervention / Treatment: Device: iFuse Bedrock technique

Detailed 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).

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Stéphane Bourret; Phone Number: +33(0)556437017; Email: s.bourret@bordeauxnord.com
• Study Contact Backup: Name: Lisa Boue; Phone Number: +33(0)556437017; Email: l.boue@bordeauxnord.com

Study Locations

• France
  • Bordeaux, France, 33300
    • Recruiting
    • Polyclinique Bordeaux Nord Aquitaine
    • Contact: Lisa Boue; Phone Number: +33(0)556437017; Email: l.boue@bordeauxnord.com
    • Contact: Stéphane Bourret, PhD; Phone Number: +33(0)556437017; Email: s.bourret@bordeauxnord.com
    • Contact: Jean Charles Le Huec, M.D., PhD
  • Marseille, France, 13005
    • Recruiting
    • Hopitaux Universitaires de Marseille
    • Contact: Severine Quéant; Phone Number: +33(0)491389098; Email: severine.queant@ap-hm.fr
    • Contact: Stéphane Fuentes, M.D., PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
iFuse Bedrock technique; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Polyclinique Bordeaux Nord Aquitaine
• Collaborators: SI-BONE, Inc.
• Investigators: Principal Investigator: Jean Charles LE HUEC, M.D., PhD, VERTEBRA Institute, Polyclinique Bordeaux Nord Aquitaine

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 21, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Sacroiliac joint pain; Sacroiliac joint fusion; Bedrock technique; Open posterior lumbosacral fusion; Spine deformties
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Sacroiliitis
• Other Study ID Numbers: 2021-ORT03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No