JULIET®OL Study #52001

The JULIET®OL, 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®OL, 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®OL, 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®OL:

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 normal life

Radiologic criteria:

- Implant positioning
- Radicular compression

 

Indication - condition:

Symptomatic lumbar disc degenerative disease

Study type: 

Observational, cohort, retrospective analysis

Patients enrolled:

27

 

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 to work
- Time after surgery for getting back to normal life
- Implant positioning
- Radicular compression
- Adverse events narratives