Catalog excerpts
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
Open the catalog to page 1• 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
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