Activ C European Multicenter Study

Completed

• Conditions: Degenerative Disc Disease; Intervertebral Disc Replacement

• Registration Number: NCT02492724
• Lead Sponsor: Aesculap AG

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 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.

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2009-12
• Study Completion: 2013-12
• Status Verified: 2015-07
• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-07-08
• Last Update Submitted: 2015-07-08
• Study First Posted: 2015-07-09
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Symptomatic single-level cervical degenerative disc disease with neck and/or arm
• pain and/or neurological deficit, confirmed by MR scan
• Single-level surgery and single-level implantation of prosthesis between C3 and C7
• Age between 18 - 65 years at the time of surgery
• Pre-operative disc space height of the segment to be operated of at least 3mm
• Unsuccessful adequate conservative treatment
• Patient understands the conditions of the study and is willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
• Patient signed Informed Consent

Exclusion Criteria

• Major facet joint degeneration at the segment to be operated on
• Severe spondylosis at the segment to be operated on (bridging osteophytes, absence of motion (<2°))
• Pre-operative disc space height of the segment to be operated on of less than 3mm
• Major cervical segmental instability at the segment to be operated on (translation ≥3,5 mm and/or ≥11° of rotational difference to that of either adjacent level)
• Previous trauma to the segment to be operated on resulting in compression or bursting

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Outcome measured by the Neck Disability Index (NDI)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (10)

University Hospital Motol; 🇨🇿 Prague 6, Czech Republic

Berufsgenossenschaftliche Kliniken Bergmannstrost; 🇩🇪 Halle / Saale, Germany

Charité Berlin; 🇩🇪 Berlin, Germany

Katholisches Klinikum Koblenz; 🇩🇪 Koblenz, Germany

Neurosurgery at Instituti Fisioterapici Ospitalieri IFO; 🇮🇹 Rome, Italy

Universität Rostock, Abteilung Neurochirurgie; 🇩🇪 Rostock, Germany

Warrington District General Hospital; 🇬🇧 Warrington, United Kingdom

Faculty Hospital Motol Prague; 🇨🇿 Prague 5, Czech Republic

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Regional Hospital Liberec; 🇨🇿 Liberec, Czech Republic