Activ C European Multicenter Study

July 8, 2015 updated by: Aesculap AG

Activ C Disc Prosthesis European Multi-Center Clinical Investigation

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Liberec, Czech Republic, 46063
        • Regional Hospital Liberec
      • Prague 5, Czech Republic, 150 06
        • Faculty Hospital Motol Prague
      • Prague 6, Czech Republic, 16000
        • University Hospital Motol
  • Finland
      • Helsinki, Finland, FI-00029 HUS
        • Helsinki University Central Hospital
  • Germany
      • Berlin, Germany, 10709
        • Charité Berlin
      • Halle / Saale, Germany, 06112
        • Berufsgenossenschaftliche Kliniken Bergmannstrost
      • Koblenz, Germany, 56073
        • Katholisches Klinikum Koblenz
      • Rostock, Germany, 18057
        • Universität Rostock, Abteilung Neurochirurgie
  • Italy
      • Rome, Italy, 00114
        • Neurosurgery at Instituti Fisioterapici Ospitalieri IFO
  • United Kingdom
      • Warrington, United Kingdom, WA4 4LU
        • Warrington District General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Investigators

  • Principal Investigator: Petr Suchomel, MD PhD, Neurocentre, Regional Hospital Liberec, Liberec, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 6, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (Estimate)

July 9, 2015

Study Record Updates

Last Update Posted (Estimate)

July 9, 2015

Last Update Submitted That Met QC Criteria

July 8, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-0707

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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