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JULIET®AN - 1 Pages

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JULIET®AN

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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