Clinical Trial: Activ C European Multicenter Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Activ C Disc Prosthesis European Multi-Center Clinical Investigation

Brief 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 Summary:

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.


Sponsor: Aesculap AG

Current Primary Outcome: Clinical Outcome measured by the Neck Disability Index (NDI) [ Time Frame: 4 years ]

The primary endpoint of the study will be changes in the clinical outcome measured by the Neck Disability Index (NDI) as published by Vernon et. al.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visual Analogue Scale (VAS) on severity of neck pain and arm pain (experienced in the pain-dominant arm) [ Time Frame: 4 years ]
  • Visual Analogue Scale (VAS) on frequency of neck pain and arm pain (experienced in the pain-dominant arm) [ Time Frame: 4 years ]
  • Adjacent segment degeneration [ Time Frame: 4 years ]
  • Postoperative angular motion on flexion/extension radiographs in the replaced segment [ Time Frame: 4 years ]
  • Complication rates (device related and non-device related) [ Time Frame: 4 years ]
  • Overall success rate [ Time Frame: 4 years ]


Original Secondary Outcome: Same as current

Information By: Aesculap AG

Dates:
Date Received: July 6, 2015
Date Started: February 2007
Date Completion:
Last Updated: July 8, 2015
Last Verified: July 2015