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TRYPTIK ® CA

TRYPTIK ® CA

TRYPTIK ® CA

Product catalog summary
Study Overview: This document details a completed investigator-initiated study conducted in France, evaluating the safety and effectiveness of the TRYPTIK®CA, a poly-ether-ether-ketone intersomatic cervical anatomical cage, for treating spinal degenerative discopathy through decompression and anterior arthrodesis.
Primary Objectives: The study aimed to assess the safety of the TRYPTIK®CA cage over a follow-up period of up to 31 months, focusing on implant-related complications, absence of neck and arm pain, neurologic disorders, fusion status, patient satisfaction, and overall prognosis.
Secondary Objectives: Early effectiveness was evaluated at 3 months post-operation, focusing on pain relief, functional improvement, quality of life, patient satisfaction, return to work, and radiologic assessment of the implant and fusion process.
Study Design: This was an observational, cohort, retrospective analysis involving 31 patients with symptomatic cervical disc degenerative disease.
Primary Outcomes: Key outcomes included the incidence of serious adverse events (SAE) and adverse events (AE) related to the implant, persistence of pain, absence of neurologic disorders, fusion status, patient satisfaction, and global prognosis.
Secondary Outcomes: These included changes in neck and arm pain, time to return to work, changes in physical activity capacity, pain medication usage, neurologic disorders, time to return to normal life, implant positioning, and narratives of adverse events.
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Catalog excerpts

TRYPTIK ® CA-1

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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TRYPTIK ® CA-2

• 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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