Comparative study of the cervical disc prothesis Rhine™ (K2M) in comparison to Anterior Cervical Discectomy and Fusion in patients with symptomatic radiculo- and/or myelopathy - theoretically possible and clinically verifiable differences due to the movable and non-movable design of cervical spacers in medium-term follow-up

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00018069

Enrollment

Registered

2019-09-10

Start date

2019-09-16

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

M50.1 M48.02

Interventions

Group 1: Implantation cervical disc prothesis Rhine™ (K2M) Group 2: ACDF Anterior Cervical Discectomy and Fusion

Eligibility

Sex/Gender

All

Age

20 Years to 85 Years

Inclusion criteria

Inclusion criteria: Entirety of the patients who were provided with the cervical disc prothesis Rhine™ (K2M) or an ACDF and whose surgery appointment allowed the long-term analysis

Exclusion criteria

Exclusion criteria: Missing declaration of consent

Design outcomes

Primary

Measure	Time frame
Prevention of ASD Adjacent Segment Degeneration in the following two years	—

Secondary

Measure	Time frame
Pain reduction, restoration of motoric function und sensibility, ROM range of motion, heterotopic ossification, sintering, dysphagia, hoarseness	—

Countries

Germany

Contacts

Public ContactRichard Bostelmann

Universitätsklinikum Düsseldorf

Richard.Bostelmann@uni-duesseldorf.deTelefon: (0211) 81 08037

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026