Evaluation of the safety and the performance of the TRYPTIK2®C-Plate Cervical Plate System on patient treated for cervical degenerative disease or trauma

Evaluation of clinical and radiographic outcomes after cervical arthrodesis surgery using a TRYPTIK2®C-Plate Anterior Cervical Plate System

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11908022

Enrollment

Registered

2023-01-31

Start date

2021-09-27

Completion date

Unknown

Last updated

2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelopathy and/or radiculopathy, or trauma Nervous System Diseases

Interventions

Retrospective study which will include approximately 70 CDDD consecutive patients (depending on the recruitment) having received the TRYPTIK®2C-Plate Anterior Cervical Plate between 2018 and 2020, to

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years 2. Patients who have received one TRYPTIK®2C-Plate as per the IFU 3. Informed consent/Information letter signed

Exclusion criteria

Exclusion criteria: Off label surgeries

Design outcomes

Primary

Measure	Time frame
1. Performance assessed qualitatively by radiological imaging at =12 months: 1.1. Stability: Preservation of the implant position: good, absent 1.2. Absence of mobility chambers around the screws: yes, no 2. Safety assessed by the rate of device failure, defined as revision surgery; cage or screw migration; screw pullout; clip disconnection; cage, plate, screw fracture; plate failure; device component misplacement measured using patient records.	—

Measure

Time frame

1. Performance assessed qualitatively by radiological imaging at =12 months: 1.1. Stability: Preservation of the implant position: good, absent 1.2. Absence of mobility chambers around the screws: yes, no 2. Safety assessed by the rate of device failure, defined as revision surgery; cage or screw migration; screw pullout; clip disconnection; cage, plate, screw fracture; plate failure; device component misplacement measured using patient records.

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Secondary

Measure	Time frame
1. Evaluation of safety associated with the implantation of Tryptik 2C Plate, from surgery and up to the last follow-up (Safety assessment intra-operatively and post-surgery by reporting the incidence and time to resolution of all complications and adverse events related to the medical device and/or procedure, including all surgical revisions). 2. Evaluation of the performance of Tryptik 2C Plate assessed at approximately 1-6 months post-surgery as per standard practice. 3. Clinical and neurologic evaluation pre-operatively and post-surgery at approximately 1-6 months and at =12 months per standard practice. 4. Pain evaluation by self-reported VAS questionnaire at last follow-up post-surgery. 5. Assessment of Neck Disability Index, by the self-reported NDI questionnaire at last follow-up post-surgery. 6. Quality of life in relation to health and patient satisfaction through the self-reported SF-12 questionnaire at last follow-up post-surgery. 7. Assessment of time to return to work post-surgery. 8. Fusion of the interbody cage at the treated levels: acquired, in progress, absent, pseudoarthrosis at approximately 1-6 months and at =12 months post-surgery as per standard practice. 9. Evaluation of the TRYPTIK®2C-Plate instrumentation supporting the surgery.	—

Measure

Time frame

1. Evaluation of safety associated with the implantation of Tryptik 2C Plate, from surgery and up to the last follow-up (Safety assessment intra-operatively and post-surgery by reporting the incidence and time to resolution of all complications and adverse events related to the medical device and/or procedure, including all surgical revisions). 2. Evaluation of the performance of Tryptik 2C Plate assessed at approximately 1-6 months post-surgery as per standard practice. 3. Clinical and neurologic evaluation pre-operatively and post-surgery at approximately 1-6 months and at =12 months per standard practice. 4. Pain evaluation by self-reported VAS questionnaire at last follow-up post-surgery. 5. Assessment of Neck Disability Index, by the self-reported NDI questionnaire at last follow-up post-surgery. 6. Quality of life in relation to health and patient satisfaction through the self-reported SF-12 questionnaire at last follow-up post-surgery. 7. Assessment of time to return to work post-surgery. 8. Fusion of the interbody cage at the treated levels: acquired, in progress, absent, pseudoarthrosis at approximately 1-6 months and at =12 months post-surgery as per standard practice. 9. Evaluation of the TRYPTIK®2C-Plate instrumentation supporting the surgery.

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Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026