NCT02492724

Activ C European Multicenter Study

Activ C Disc Prosthesis European Multi-Center Clinical Investigation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 210 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who suffer from cervical symptomatic degenerative disc disease. A maximum of 200 cases will be enrolled into the study. An 18-month recruitment period is planned with a 4-year postoperative follow-up period for each subject. Thus, it is anticipated that the study will require a minimum of 5.5 years. Patients will be assessed preoperatively, intraoperatively, prior to discharge and again at 6 weeks, 6 months, 1 year, 2 years and 4 years postoperatively from the date of surgery.

Detailed description

The activ C Disc Prosthesis pursues the goal of restoring the disc function, the geometry and motion of the cervical disc. Its concept is based on a ball and socket joint, anchored between adjacent vertebral bodies. The modular prosthesis comprises the following elements: an inferior CoCr plate component anchored in the endplate of the caudal vertebral body. The UHMWPE inlay is securely fixed in this inferior component. The second element is the superior CoCr component, which is anchored in the end plate of the cranial vertebral body. It forms a ball joint with the inlay of the inferior plate component. The activ C product range enables reconstruction of various disc heights as well as adaptation to the end plate sizes. Secure primary anchorage of the prosthesis to the vertebral bodies is achieved by convexly shaped superior end pla tes and fixation means (spikes and grooves on the superior end plate, a small keel on the inferior end plate), whereas secondary stability is facilitated by an osseointegrative Plasmapore® coating. The objective of the study is to collect outcome information on the Activ® C Disc Prosthesis.

Conditions

• Intervertebral Disc Replacement
• Degenerative Disc Disease

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-12-01
• Completion: 2013-12-01
• First posted: 2015-07-09
• Last updated: 2015-07-09

Locations

10 sites across 5 countries: Czechia, Finland, Germany, Italy, United Kingdom