NCT05035693

Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C

"PMCF MOVE®-C" International, Prospective, Multicentre, Non-randomised Post-market Clinical Follow-up Study Clinical and Radiological Outcome After Mono- and Bisegmental Cervical Intervertebral Disc Prosthetics

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: NGMedical GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG. Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.

Detailed description

This clinical investigation is conducted to gain post market results on the Cervical Disc Prosthesis MOVE®-C and to demonstrate the safety and performance. Besides, it is aimed to gain knowledge concerning the development of patients' quality of life (QoL) after the implantation of the Cervical Disc Prosthesis MOVE®-C and to collect data for the analysis of the range of motion (ROM), which is an essential parameter for motion-preserving implants.

Conditions

• Discopathy
• Herniated Cervical Disc
• Stenoses, Spinal
• Radiculopathy

Interventions

Type	Name	Description
DEVICE	MOVE®-C	Momo- or bisegmental implantation of MOVE®-C cervical prothesis.

Timeline

• Start date: 2021-03-11
• Primary completion: 2025-03-11
• Completion: 2027-03-11
• First posted: 2021-09-05
• Last updated: 2024-11-15

Locations

7 sites across 2 countries: Austria, Germany