TRYPTIK®MC Study #33001

Cervico-brachial neuralgia treated by decompression and anterior arthrodesis using intersomatic poly-ether-ether-ketone and titanium cervical anatomical modular cage-plate TRYPTIK®MC. Evaluation of safety and effectiveness.

Investigator Initiated Study

Not FDA approved

Region: France

Status: Completed

 

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

 

Primary Objective:

Safety of TRYPTIK®MC cervical inter-somatic cage-plate, evaluation based on all events observed

(controls, investigations, hospitalizations, interventions) during 2 year follow-up after arthrodesis:

• Overall performance of TRYPTIK®MC, 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 radicular pain
- Absence of neurologic deficit
- Patient satisfaction
- Fusion
- Global prognostic

 

Secondary objectives:

Early qualitative effectiveness evaluation, at 2 months after surgery for cervical arthrodesis using TRYPTIK®MC

Overall success evaluated by clinical and neurological criteria:

- Pain relief
- Mobility improvement (flexion/extension and rotation)
- Neurological deficit
- Pain medication
- Evolution
- Kinesitherapy

Overall success evaluated by socio-economic criteria:

- Time after surgery for getting back to work
- Time after surgery for getting back to normal life

Radiologic criteria:

- Implant positioning
- Radicular compression

 

Indications - condition:

Patients with cervico-brachial neuralgia, with 6-month prior conservative treatment who underwent anterior cervical arthrodesis at one or more levels with intersomatic modular cage-plate TRYPTIK®MC.

 

Study type:

Observational, cohort, retrospective analysis

 

Patients enrolled:

59

 

Primary outcomes:

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

 

Secondary outcomes:

• Changes in Pain (compared to preoperative status)
• Mobility improvement in flexion/extension and rotation (compared to preoperative status)
• Pain medication (drug’s category and frequency)
• Radicular pain
• 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

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