JULIET® PO study #12002

The JULIET®PO, lumbar intersomatic Poly-Ether-Ether-Ketone cage used for symptomatic degenerative disc diseases treatment by arthrodesis. Safety and effectiveness evaluation after five years follow-up

Investigator Initiated Study

FDA approved

Region: France

Status: Completed

 

Post CE-Marking Follow-up Study 

 

Primary Objectives:

Safety of JULIET®PO, lumbar inter-somatic cage, evaluation based on all events observed (controls, investigations, hospitalizations, interventions) during 5 year follow-up after arthrodesis

 

Secondary objectives:

• Overall performance of JULIET®PO, evaluated at the end of 5 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

 

Indication - condition:

Symptomatic lumbar disc degenerative disease

 

Study type:

Observational, cohort, retrospective analysis 

 

Patients enrolled:

138

 

Primary outcomes:

• Incidence of SAE and AE implant related
• Fusion status
• Patient satisfaction
• Global prognostic

 

Secondary outcomes:

• Absence of lumbar and radicular pain
• Absence of neurologic disorders (sensitive and/or motor)
• Implant positioning
• Radicular compression
• Adverse events narratives

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