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TRYPTIK ® CA - 2 Pages

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TRYPTIK ® CA

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

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• 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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