Clinical trial NCT05276024: Evaluation of the IFuse Bedrock Technique in Association with Posterior Lumbosacral Fusion with Iliac Fixation.
Official title: Evaluation of the IFuse Bedrock Technique in Association with Posterior Lumbosacral Fusion with Iliac Fixation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sacroiliitis
Sacroiliac; Fusion
Lumbosacral; Fusion
Spine Deformity
Keywords: Sacroiliac joint pain
Sacroiliac joint fusion
Bedrock technique
Open posterior lumbosacral fusion
Spine deformties
Lead sponsor: Polyclinique Bordeaux Nord Aquitaine
Sponsor class: OTHER
Collaborators: name: SI-BONE, Inc.
First posted: 2022-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in self-reported Oswestry Disability Index (ODI) at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in sacroiliac joint pain provocation tests.
timeFrame: During 12 months
measure: Assessment of the Oswestry Disability Index
timeFrame: 3 and 6 months
measure: Improvement of back and leg pains at 3, 6 and 12 months compared to preoperative scores
timeFrame: 3, 6 and 12 months
measure: Change in Patient's quality of life
timeFrame: 3, 6 and 12 months
measure: Proportion of subjects with postoperative SIJ fusion failure
timeFrame: 12 months
measure: Impact of iFuse Bedrock technique on Pelvic Incidence
timeFrame: During 12 months
measure: Impact of iFuse Bedrock technique on Pelvic Tilt
timeFrame: During 12 months
measure: Impact of iFuse Bedrock technique on Sacral Slope
timeFrame: During 12 months
measure: Impact of iFuse Bedrock technique on Lumbar Lordosis
timeFrame: During 12 months
measure: Impact of iFuse Bedrock technique on Thoracic Kyphosis
timeFrame: During 12 months
measure: Impact of iFuse Bedrock technique on the Odontoid Hip Axis
timeFrame: During 12 months
measure: Impact of iFuse Bedrock technique on the T1 pelvic angle
timeFrame: During 12 months
measure: Proportion of subjects with iFuse-3D implant-related complications
timeFrame: 12 months
measure: Incidence of any serious adverse events
timeFrame: During 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Marseille
country: France
facility: Hôpitaux Universitaires de Marseille
Study officials:
affiliation: VERTEBRA Institute, Polyclinique Bordeaux Nord Aquitaine
name: Jean Charles Le Huec, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: