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JULIET® PO - 2 Pages

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JULIET® PO

Catalog excerpts

JULIET®PO Study #12001 The JULIET®PO, lumbar intersomatic poly-ether-ether-ketone cage used for symptomatic degenerative disc diseases treatment by arthrodesis. Safety and effectiveness evaluation after two years follow-up Investigator Initiated Study FDA approved for this indication Region: France Status: Completed Post CE-Marking Follow-up Study submitted to HAS (FR) Primary Objectives: Safety of JULIET®PO, lumbar inter-somatic cage, evaluation based on all events observed (controls, investigations, hospitalizations, interventions) during 2 year follow-up after arthrodesis Overall performance of JULIET®PO, evaluated at the end of 2 years follow-up period, as a composite primary endpoint, based on data at last visit: - Incidence and seriousness of implant related complications - Absence of lumbar and radicular pain - Absence of neurologic disorders (sensitive and/or motor) - Fusion status - Patient satisfaction - Global prognostic Secondary objectives: Early qualitative effectiveness evaluation, at 2 months after surgery for lumbar arthrodesis using JULIET®PO: Overall success evaluated by Stauffer criteria: - Pain relief - Time after surgery for getting back to work - Diminution of physical activities - Pain medication Functional improvement evaluated by Lassale criteria: - Claudication - Radicular pain (at rest and at effort) - Lumbar pain - Neurologic disorders - Pain medication - Kinesitherapy - Time after surgery for getting back to work and normal life Radiologic criteria: - Implant positioning - Radicular compression Indication - condition: Symptomatic lumbar disc degenerative disease Study type: Observational, cohort, retrospective analysis Patients enrolled: 138 Primary outcomes:

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• Incidence of SAE and AE implant related • Absence of lumbar and radicular pain • Absence of neurologic disorders (sensitive and/or motor) • Fusion status • Patient satisfaction • Global prognostic Secondary outcomes: • Changes in back and leg pain (compared to preoperative status) • Changes in physical activities capacity (compared to preoperative status) • Pain medication (drug's category and frequency) • Radicular pain (at rest and at effort) • Neurologic disorders (motor and/or sensitive) • Time after surgery for getting back work and normal life • Implant positioning • Radicular...

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