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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 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05276024
Study type Observational
Source Polyclinique Bordeaux Nord Aquitaine
Contact Stéphane Bourret
Phone +33(0)556437017
Email s.bourret@bordeauxnord.com
Status Recruiting
Phase
Start date June 10, 2022
Completion date April 1, 2024
View Details
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