TRYPTIK®CA Study #32001

Spinal degenerative discopathy treated by decompression and anterior arthrodesis with intersomatic Poly-Ether-Ether-Ketone anatomical cervical cage TRYPTIK®CA. Evaluation of safety and effectiveness

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 evaluation of TRYPTIK®CA, poly-ether-ether-ketone intersomatic cervical anatomic cage, based on all events observed (controls, investigations, hospitalizations, interventions) during up to 31 months follow-up after arthrodesis
• Overall performance of TRYPTIK®CA, evaluated at the end of follow-up period, as a composite

primary endpoint, based on data at last visit:

- Incidence and seriousness of implant related complications
- Absence of neck and arm pain
- Absence of neurologic disorders (sensitive and/or motor)
- Fusion status
- Patient satisfaction
- Global prognostic

 

Secondary objectives:

Early effectiveness assessment, at 3 months post-op for cervical arthrodesis using TRYPTIK®CA:

- Neck and arm pain relief, evaluated by VAS scores
- Functional improvement evaluated by NDI scores
- Quality of Life and Patient satisfaction, evaluated by Odom criteria
- Back to work and normal life
- Radiologic assessment of implant status and fusion process.

 

Indication - condition:

Symptomatic cervical disc degenerative disease

 

Study type:

Observational, cohort, retrospective analysis

 

Patients enrolled:

31

 

Primary outcomes:

• Incidence of SAE and AE implant related
• Persistence of neck and/or arm pain
• Absence of neurologic disorders (sensitive and/or motor)
• Fusion status
• Patient satisfaction
• Global prognostic

 

Secondary outcomes:

• Neck and arm pain (compared to preoperative status)
• Time after surgery for getting back to work
• Changes in physical activities capacity (compared to preoperative status)
• Pain medication (drug’s category and frequency)
• Neurologic disorders (motor and/or sensitive)
• Time after surgery for getting back to normal life
• Implant positioning
• Adverse events narratives