Evaluation of the TEKTONA® system designed to restore vertebral height in the treatment of vertebral fractures by compression
| ISRCTN | ISRCTN10328801 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10328801 |
| Secondary identifying numbers | P61_CLD001 |
- Submission date
- 13/04/2023
- Registration date
- 14/06/2023
- Last edited
- 02/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This is a post-market study to confirm the performance and safety of the TEKTONA system in the treatment of vertebral compression fractures. A compression fracture is usually defined as a vertebral bone in the spine that has decreased at least 15 to 20% in height due to fracture. The TEKTONA medical device reduces the vertebral fracture and allows the cement injection in the vertebra to consolidate it.
Who can participate?
Patients aged 18 years and over with vertebral compression fracture
What does the study involve?
The patient is screened during the preoperative visit. Those patients who are eligible for the study are invited to participate in the study. After reading the information letter, the patients should let their surgeon know if they agree/consent before any data collection. Clinical and radiographic data are collected at their preoperative, surgical, and postoperative clinical visits performed as the site standard of care.
What are the possible benefit and risks of participating?
As an observational study, there is no benefit or risk for the patients participating in the study.
Where is the study run from?
Spineart SA (Switzerland)
When is the study starting and how long is it expected to run for?
January 2016 to December 2020
Who is funding the study?
Spineart SA (Switzerland)
Who is the main contact?
clinic@spineart.com
Contact information
Scientific
3, chemin du Pré Fleuri
Plan-les-Ouates
1228
Switzerland
| Phone | +41 (0)225701261 |
|---|---|
| dbermingham@spineart.com |
Study information
| Study design | Post-market clinical follow-up (PMCF) prospective multicenter single-arm observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Non-randomized study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format |
| Scientific title | Evaluation of the safety and performance of the compression spinal fracture treatment system, TEKTONA® prospective study |
| Study acronym | TEKTONA® system |
| Study objectives | The TEKTONA® system is designed to restore the vertebral height and reduce the angle of vertebral kyphosis, for the treatment of osteoporotic or osteopathic vertebral settlement fractures (FTV) Type A1 and A2 (a gap between fragments of less than 2 mm) and A3 in the MAGERL classification. |
| Ethics approval(s) | Approved 26/04/2016, CPP Ile-de-France VI (Groupe Hospitalier Pitié-Salpêtrière, 47 Boulevard de l'Hôpital, 75013, Paris, France; +33 (0)1 42 16 16 83; cppidf6.salpetriere@yahoo.fr), ref: ID RCB 2016-A00150-51, CCTIRS # 16-640 |
| Health condition(s) or problem(s) studied | Vertebral compression fracture, stable type, without neurological deficit |
| Intervention | Evaluation of qualitative and quantitative of pre-, peri- and post-operative data. Comparison between pre-and post-operative values provided by radiological parameters, pain medication, VAS, ODI and SF-12 scores. The risk assessment is determined by the rate of complications observed. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | TEKTONA® |
| Primary outcome measure | 1. Risks are measured by the incidence of perioperative complications and safety reporting and post-operative risks (adverse events reporting, radiological assessments at 6, 12 and 24 months) 2. Restoration of vertebral height (mm) and reduction of kyphosis (Cobb Angle) at the level operated is measured by comparing radiological images pre-surgery, perioperative, immediate post-surgery, at 6-, 12- and 24-months post-surgery |
| Secondary outcome measures | 1. Volume of cement injected and cement distribution (vertebral and horizontal) is measured (in ml) at surgery 2. Effectiveness of the system is measured by the duration of post-operative hospitalization 3. Pain is evaluated by changes in the use of pain medication and the visual analogue score (VAS) score pre-surgery, immediate post-surgery, at 6-, 12- and 24-months post-surgery 4. Quality of life is measured using the SF-12 questionnaire preoperatively, immediate postoperatively and at 6, 12 and 24 months and time between intervention and back to work 5. Functional evaluation using Oswestry Disability Index (ODI) score preoperatively, immediate postoperatively and at 6, 12 and 24 months |
| Overall study start date | 26/01/2016 |
| Completion date | 07/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 37 |
| Key inclusion criteria | 1. Aged 18 years or older 2. Presenting one or more three stable vertebral fractures at non-adjacent levels, fractures type A1.1, A1.2, A1.3, A2 (gap between fragments less than 2 mm) and A3.1, A3.2, A3.3 according to Magerl classification 3. Presenting vertebral traumatic fracture(s), due to high-energy trauma, or osteoporotic fall of one's own height 4. Able to understand the investigation protocol, agree with the investigation plan, and complete the necessary documents 5. Who voluntarily signed the informed consent form |
| Key exclusion criteria | 1. Anterior treatment with cyphoplasty at the fractured level 2. Unstable fractures of type B or C according to Magerl 3. Size of the pedicules incompatible with safe access to the instrument |
| Date of first enrolment | 22/11/2016 |
| Date of final enrolment | 12/12/2018 |
Locations
Countries of recruitment
- France
Study participating centres
47-83 Bd de l’Hôpital
Paris
75651
France
Grenoble
38043
France
1, Place de L’Hôpital
Strasbourg
67000
France
Sponsor information
Industry
Chemin du Pré-Fleuri 3
Plan-les-Ouates
1228
Switzerland
| Phone | +33 (0)225701200 |
|---|---|
| clinic@spineart.com | |
| Website | https://www.spineart.com/ |
"ROR" |
https://ror.org/05sz2c652 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Additional documents can be obtained upon request from clinic@spineart.com. |
| IPD sharing plan | The dataset generated and analysed during the current study will be available upon request from clinic@spineart.com. The type of data that will be shared: clinical data of the study Dates of availability: up to 2035 Whether consent from participants was required and obtained: Yes Comments on data anonymization: All subjects' data are pseudo-anonymized Any ethical or legal restrictions: No restrictions |
Editorial Notes
02/06/2023: Study's existence confirmed by the CPP Ile-de-France VI.
