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

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:

• 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)
• Claudication
• Radicular pain (at rest and at effort)
• Neurologic disorders (motor and/or sensitive)
• Kinesitherapy
• Time after surgery for getting back work and normal life
• Implant positioning
• Radicular compression
• Adverse events narratives

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