NCT02936765

Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Spacer Squale (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 devices (prosthesis vs rigid spacer) 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 / Squale.	Anterior cervical discectomy, with the use of the Squale spacer (Manufacturer: OSD, Avignon, France) 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