JULIET®AN

Product catalog summary

Study Overview: This document details a prospective safety and effectiveness study of the JULIET®AN system combined with rhBMP2 for treating symptomatic degenerative disc diseases through anterior lumbar arthrodesis. Conducted in France, the study is investigator-initiated and FDA-approved for this indication. It has been completed and submitted as a post CE-Marking follow-up study to the French Health Authority (HAS).

Primary Objectives: The study aimed to evaluate the overall performance of the JULIET®AN system over a two-year follow-up period. The primary composite endpoint included the incidence and seriousness of implant-related complications, a two-point improvement in back and leg pain as measured by the Visual Analog Scale (VAS), and functional improvement assessed by the Oswestry Disability Index (ODI).

Secondary Objectives: The study also focused on the dynamic evaluation of physical and neurological outcomes at 2, 6, 12, and 24 months post-surgery. Radiologic assessments were conducted to evaluate fusion status, implant positioning, and radicular compression.

Study Details: The study is observational, cohort-based, and involves a prospective analysis. A total of 33 patients with symptomatic lumbar disc degenerative disease were enrolled.

Primary Outcomes: The primary outcomes measured were the incidence of serious adverse events (SAE) and adverse events (AE) related to the implant, changes in back and leg pain compared to preoperative status, and changes in the ODI score compared to preoperative status.

Secondary Outcomes: Secondary outcomes included assessments of fusion status, implant positioning, radicular compression, and narratives of adverse events.

Catalog excerpts

JULIET®AN Study #14001 Symptomatic degenerative disc diseases treated by anterior lumbar arthrodesis with JULIET®AN and rhBMP2. A prospective safety and effectiveness study Investigator initiated study FDA approved for this indication Region: France Status: Completed Post CE-Marking Follow-up Study submitted to HAS (FR) Primary Objectives:  Overall performance of JULIET®AN, evaluated at the end of 2 years follow-up period, as a composite primary endpoint: - Incidence and seriousness of implant related complications - 2 points improvement for back and leg pain (VAS) - Functional improvement evaluated by Oswestry Disability Index (ODI) Secondary objectives:  Dynamic evaluation of physical and neurological outcomes, controlled at 2, 6, 12 and 24 months after surgery for lumbar arthrodesis using JULIET®AN:  Radiologic assessment : - Fusion status - Implant positioning - Radicular compression Indication - condition: Symptomatic lumbar disc degenerative disease Study type: Observational, cohort, prospective analysis Patients enrolled: 33 Primary outcomes: • Incidence of SAE and AE implant related • Changes in back and leg pain (compared to preoperative status) • Changes in ODI score (compared to preoperative status) Secondary outcomes: • Fusion status • Implant positioning • Radicular compression • Adve

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