Clinical study on 15 years follow up after neck surgery with Baguera®C device.

15-year follow up after surgery with Baguera®C cervical disc prosthesis for treatment of cervical degenerative disease.

Registry ID
ISRCTN11828907
Source registry
ISRCTN
Status
Recruiting
Phase
PHASE4
Study type
OBSERVATIONAL
Sponsor
Spineart (Switzerland)
Enrollment
88
Start date
2026-03-24
Completion date
2026-09-30
Last update
2026-08-17

Conditions

Summary

Cervical disk arthroplasty (CDA) for the treatment of Symptomatic cervical disc disease (SCDD) affecting one level or two adjacent levels between C3 and C7.

Detailed description

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.

Interventions

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

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

Locations

Related clinical trials

View on source registry