Evaluation of the clinical results of the cervical disc prosthesis ROATIO in the longterm Follow-up

Evaluation of the clinical results of the cervical disc prosthesis ROATIO in the longterm Follow-up - ROTAIO Longterm

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040397

Enrollment

Registered

2026-05-19

Start date

2026-06-22

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Cervical disorders in the C3–C7 region, such as discopathy, herniated disc, foraminal stenosis, and spinal stenosis.

Interventions

Group 1: The overall objective is the collection of long-term clinical data to compare the long-term performance of the ROTAIO implant in its certified application. This is a monocentric, non-randomiz

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients at the study center who received a ROTAIO prosthesis, the implantation of which occurred more than 54 months ago.

Exclusion criteria

Exclusion criteria: • Vulnerable patient groups (pregnant and breastfeeding women, people with intellectual disabilities)

Design outcomes

Primary

Measure	Time frame
• Odom’s Criteria (Success Rate), Nurick Score • PROMs: NDI, VAS, EQ-5D-5L, PSI, mJOA • Safety This study comprises only one visit. Data collection takes place >54 months after implantation of ROTAIO. Data are collected via CRFs and validated questionnaires.	—

Secondary

Measure	Time frame
• Radiological mobility / Dynamic radiographs • Rate of radiological / symptomatic adjacent segment degeneration (ASD) • Subsidence / Migration / Dislocation of the implant	—

Countries

Austria

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026