Evaluation of the safety and the performance of the TRYPTIK2®C-Plate Cervical Plate System on patient treated for cervical degenerative disease or trauma
| ISRCTN | ISRCTN11908022 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11908022 |
| Secondary identifying numbers | P65_CLD001 |
- Submission date
- 25/01/2023
- Registration date
- 31/01/2023
- Last edited
- 26/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
This study will look at how well a device called the TRYPTIK2®C-Plate works in a type of surgery called Anterior Cervical Discectomy and Fusion (ACDF) for people with Degenerative Disc Disease (DDD), spondylosis, or trauma. The TRYPTIK2®C-Plate is made up of different sizes of plates and screws that are used to hold the spine in place. The screws have a special locking feature that keeps them from coming loose. The study will see how well this device works, if it has any benefits and if it is safe to use.
Who can participate?
The device is used for its intended use and patients represent the intended population. All patients required an anterior cervical discectomy with fusion, between C2 and C7 and up to 4 consecutive levels, due to symptomatic cervical degenerative disc disease (CDDD), after unsuccessful non-operative treatment.
What does the study involve?
Retrospective data will be collected for patients who underwent surgery between 2018 and 2020. All visits are standard and data collected will consist in pre-operative, surgery, post-operative before discharge, post-surgery at approximately 1-6 months, at ≥12 months and at the last follow up at enrollment (prospective visit). The study does not involve additional examinations.
What are the possible benefit and risks of participating?
There are no anticipated benefits for the patient. The information obtained from this study will be used to confirm the safety and efficacy of the TRYPTIK®2C-Plate as a part of the Post-Market Surveillance.
There is no risk inherent to the study participation as this is a retrospective study that does not involve any additional examinations for the patients.
Where is the study run from?
Spineart (Switzerland)
When is the study starting and how long is it expected to run for?
April 2021 to April 2022
Who is funding the study?
Spineart (Switzerland)
Who is the main contact?
clinic@spineart.com
Contact information
Scientific
3, chemin du Pré Fleuri
Plan-les-Ouates
1228
Switzerland
| Phone | +41 225701261 |
|---|---|
| dbermingham@spineart.com |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Evaluation of clinical and radiographic outcomes after cervical arthrodesis surgery using a TRYPTIK2®C-Plate Anterior Cervical Plate System |
| Study acronym | Tryptik 2C-Plate |
| Study hypothesis | Evaluation of the performance and safety of the Tryptik 2C-Plate device in the treatment of myelopathy and/or radiculopathy, or trauma. |
| Ethics approval(s) | Approved 02/06/2021, Comité de Ética de la Investigación con medicmentos (CElm del Hospital Clínoco Universitario de Valencia; +34 96 1973976; ceic_hvc@gva.es) ref. 94/21 |
| Condition | Myelopathy and/or radiculopathy, or trauma |
| Intervention | 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 evaluate the performance and safety of the device. The pre-operative data, surgical data, discharge data and short to medium term follow-up data (Visit 4: 1-6 months after surgery, Visit 5: ≥12 months after surgery) were collected retrospectively. No randomization or blinding took place during the study. One prospective visit was performed after the patient was enrolled to collect the patient self-assessment questionnaires and to answer safety questions. The data collection will reflect the site standard practice and the IFU. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | TRYPTIK®2C-Plate Anterior Cervical Plate |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/04/2021 |
| Overall study end date | 22/04/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 42 |
| Participant 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 |
| Participant exclusion criteria | Off label surgeries |
| Recruitment start date | 27/09/2021 |
| Recruitment end date | 22/04/2022 |
Locations
Countries of recruitment
- Spain
Study participating centre
Valencia
46010
Spain
Sponsor information
Industry
Chemin du Pré-Fleuri 3
Plan-les-Ouates
1228
Switzerland
| Phone | +41 22 570 12 00 |
|---|---|
| clinic@spineart.com | |
| Website | https://www.spineart.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
26/01/2023: Trial's existence confirmed by Comité de Ética de la Investigación con medicmentos.
