Clinical study on 15 years follow up after neck surgery with Baguera®C device.
| ISRCTN | ISRCTN11828907 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11828907 |
| Internal Reference | P16_CLD008 |
| Sponsor | Spineart (Switzerland) |
| Funder | Spineart (Switzerland) |
- Submission date
- 10/03/2026
- Registration date
- 11/03/2026
- Last edited
- 11/03/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Cervical Disc Arthroplasty (CDA), also called disc replacement, aims to treat neck pain and nerve problems caused by worn or damaged discs while keeping your neck moving normally, without adding extra risks or complications.
Many studies have looked at the short- and mid-term results of disc replacement surgery, but only a few have checked what happens after more than 10 years.
For Baguera®C, previous studies have already shown positive results at 2 years, 5 years and 10 years. The goal of this study is to keep monitoring, for at least 15 years, how patients are doing after receiving the Baguera®C cervical disc implant.
Who can participate?
Only patients who participated in the previous Baguera® C study and have 5-year or 10-year follow-up data can participate in this 15-year follow-up visit.
What does the study involve?
The study includes one follow-up visit, in person or remotely. Before the visit, participants will have an X-ray as prescribed and share the images. During the visit, participants will:
* Complete pain questionnaires (VAS for arm and neck)
* Complete the Neck Disability Index (NDI) questionnaire
* Report pain medication use
* Provide cervical spine history since the last follow-up
What are the possible benefits and risks of participating?
There are no anticipated benefits for the patients participating in the study. The surgery benefit will be the same whether the patients participate in the study or not.
Risks not provided at time of registration
Where is the study run from?
This is an international multicenter study coordinated by Spineart SA (Switzerland) with four participating sites in France, Belgium, Spain, and Greece.
When is the study starting and how long is it expected to run for?
The study is expected to start in March 2026 and last for 4 months (June 2026).
Who is funding the study?
Spineart SA (Switzerland).
Who is the main contact?
clinic@spineart.com.
Contact information
Public, Scientific
Spineart SA - Clinical Affairs
Chemin du Pré-Fleuri 3
Plan-les-Ouates
1228
Switzerland
| Phone | +41225611200 |
|---|---|
| clinic@spineart.com |
Principal investigator
Clinique du Dos Bordeaux-Terrefort
Bruges
33520
France
| Phone | +41225611200 |
|---|---|
| clinic@spineart.com |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Scientific title | 15-year follow up after surgery with Baguera®C cervical disc prosthesis for treatment of cervical degenerative disease. |
| Study acronym | Baguera®C 15-Year Follow Up Study |
| Study objectives | The aim of this study is to continue evaluating, with at least 15 years FU, the clinical and radiological outcomes of CDA with Baguera®C cervical prosthesis that has been demonstrated in patients in the 2- year Follow Up (FU) study P16_CLD001 and in the 5 & 10-year FU study P16-CLD005 . |
| Ethics approval(s) |
Approved 18/02/2026, Scientific Council of Agios Loukas Clinic (3 Charilaou Trikoupi Street, Panorama, Thessaloniki, 55236, Greece; +30 2310 380,000; info@klinikiagiosloukas.gr), ref: - |
| Health condition(s) or problem(s) studied | Cervical disk arthroplasty (CDA) for the treatment of Symptomatic cervical disc disease (SCDD) affecting one level or two adjacent levels between C3 and C7. |
| Intervention | This is a single-arm, multicenter, international Post-Market Clinical Follow Up (PMCF) study without additional procedures. The study will be retrospective in France. The study will be prospective in Belgium, Greece & Spain. The Baguera® C prosthesis is designed to preserve mobility at the treated cervical level when replacing a degenerated intervertebral disc. This is a 15-year observational follow-up of patients previously enrolled in the 5 & 10-year FU prospective study of the Baguera® C cervical disc prosthesis. All original participants will be invited for one visit. Assessments include cervical segment mobility by radiography, pain using VAS (arm and neck), Neck Disability Index (NDI), documentation of cervical pain treatments, and adverse event review. |
| Intervention type | Device |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Baguera®C |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 88 |
| Key inclusion criteria | 1. Patient who have completed at least one of the 5-year or 10-year FU visit within the P16-CLD005 study 2. Completed the 15-year FU visit |
| Key exclusion criteria | Patients unwilling to participate to the study, i.e.: 1. For France, have provided a written opposition for their data collection within 4 weeks after dispatch of the information letter and opposition form 2. For Belgium, Greece and Spain, have refused to sign an informed consent or withdrew consent before their 15-year FU visit |
| Date of first enrolment | 01/03/2026 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- Belgium
- France
- Greece
- Spain
Study participating centres
-
-
Spain
-
-
Greece
-
-
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
11/03/2026: Study’s existence confirmed by the Scientific Council of Agios Loukas Clinic, Greece.
