NCT02936739

Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Prosthesis Rotaio (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two different cervical disc prosthetic devices with respect to postoperative change in neck disability index. The evaluation will include clinical and radiological parameters.

Conditions

• Intervertebral Disc Displacement

Interventions

Type	Name	Description
DEVICE	Anterior cervical discectomy with prosthetic disc replacement / ESP.	Anterior cervical discectomy, with the use of the ESP prosthesis (Manufacturer: FH orthopedics, Mulhouse, France) for the disc replacement.
DEVICE	Anterior cervical discectomy with prosthetic disc replacement / Rotaio.	Anterior cervical discectomy, with the use of the Rotaio prosthesis (Manufacturer: Signus Med, Alzenau, Germany) for the disc replacement.

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-12-01
• Completion: 2019-06-01
• First posted: 2016-10-18
• Last updated: 2016-10-18

Locations

1 site across 1 country: Germany