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Recruiting NCT05276024

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

— Observational Sacroiliitis Sacroiliac; Fusion Lumbosacral; Fusion Spine Deformity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iFuse Bedrock technique.
Who it may be relevant to
Registry conditions: Sacroiliitis, Sacroiliac; Fusion, Lumbosacral; Fusion, Spine Deformity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Interventions

  • 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.

Primary outcome measures

  • Change from baseline in self-reported Oswestry Disability Index (ODI) at 12 months [Time frame: 12 months]
Secondary outcome measures (12)
  • Change from baseline in sacroiliac joint pain provocation tests. [Time frame: During 12 months]
  • Assessment of the Oswestry Disability Index [Time frame: 3 and 6 months]
  • Improvement of back and leg pains at 3, 6 and 12 months compared to preoperative scores [Time frame: 3, 6 and 12 months]
  • Change in Patient's quality of life [Time frame: 3, 6 and 12 months]
  • Proportion of subjects with postoperative SIJ fusion failure [Time frame: 12 months]
  • Impact of iFuse Bedrock technique on Pelvic Incidence [Time frame: During 12 months]
  • Impact of iFuse Bedrock technique on Pelvic Tilt [Time frame: During 12 months]
  • Impact of iFuse Bedrock technique on Sacral Slope [Time frame: During 12 months]
  • Impact of iFuse Bedrock technique on Lumbar Lordosis [Time frame: During 12 months]
  • Impact of iFuse Bedrock technique on Thoracic Kyphosis [Time frame: During 12 months]
  • Impact of iFuse Bedrock technique on the Odontoid Hip Axis [Time frame: During 12 months]
  • Impact of iFuse Bedrock technique on the T1 pelvic angle [Time frame: During 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 2 centers
  • Polyclinique Bordeaux Nord Aquitaine — Bordeaux
  • Hôpitaux Universitaires de Marseille — Marseille

Identifiers

NCT: NCT05276024 · 2021-ORT03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗