JULIET®AN Study #14001

Symptomatic degenerative disc diseases treated by anterior lumbar arthrodesis with JULIET®AN and rhBMP2. A prospective safety and effectiveness study

Investigator initiated study

FDA approved 

Region: France

Status: Completed  

 

Post CE-Marking Follow-up Study submitted to HAS (FR)

 

Primary Objectives:

• Overall performance of JULIET®AN, evaluated at the end of 2 years follow-up period, as a composite primary endpoint:

- Incidence and seriousness of implant related complications
- 2 points improvement for back and leg pain (VAS)
- Functional improvement evaluated by Oswestry Disability Index (ODI)

 

Secondary objectives:

• Dynamic evaluation of physical and neurological outcomes, controlled at 2, 6, 12 and 24 months after surgery for lumbar arthrodesis using JULIET®AN:
• Radiologic assessment :

- Fusion status
- Implant positioning
- Radicular compression

 

Indication - condition:

Symptomatic lumbar disc degenerative disease

 

Study type:

Observational, cohort, prospective analysis

 

Patients enrolled:

33

 

Primary outcomes:

• Incidence of SAE and AE implant related
• Changes in back and leg pain (compared to preoperative status)
• Changes in ODI score (compared to preoperative status)

 

Secondary outcomes:

• Fusion status
• Implant positioning
• Radicular compression
• Adverse events narratives