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JULIET® PO

JULIET® PO

JULIET® PO

Product catalog summary
Study Overview: The JULIET®PO study evaluates the safety and effectiveness of the lumbar intersomatic poly-ether-ether-ketone cage for treating symptomatic degenerative disc diseases through arthrodesis. Conducted in France, this investigator-initiated study is FDA approved and completed, with follow-up data submitted to HAS (FR).
Primary Objectives: The study focuses on the safety and overall performance of the JULIET®PO cage over a two-year follow-up period. Key metrics include the incidence and seriousness of implant-related complications, absence of lumbar and radicular pain, absence of neurologic disorders, fusion status, patient satisfaction, and global prognostic.
Secondary Objectives: Early qualitative effectiveness is assessed two months post-surgery using Stauffer and Lassale criteria. These include pain relief, return to work, physical activity levels, pain medication usage, functional improvements, and radiologic criteria such as implant positioning and radicular compression.
Study Type: This is an observational, cohort, retrospective analysis involving 138 patients.
Primary Outcomes: The study measures the incidence of serious adverse events (SAE) and adverse events (AE) related to the implant, absence of pain and neurologic disorders, fusion status, patient satisfaction, and global prognostic.
Secondary Outcomes: Changes in back and leg pain, physical activity capacity, pain medication usage, claudication, radicular pain, neurologic disorders, kinesitherapy, time to return to work and normal life, implant positioning, radicular compression, and adverse events narratives are evaluated.
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Catalog excerpts

JULIET® PO-1

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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JULIET® PO-2

• 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 compression...

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