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Activ C European Multicenter Study

NCT02492724 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 210

Last updated 2015-07-09

No results posted yet for this study

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.

Conditions

  • Intervertebral Disc Replacement
  • Degenerative Disc Disease

Sponsors & Collaborators

  • Aesculap AG

    lead INDUSTRY

Principal Investigators

  • Petr Suchomel, MD PhD · Neurocentre, Regional Hospital Liberec, Liberec, Czech Republic

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-12-31
Completion
2013-12-31

Countries

  • Czechia
  • Finland
  • Germany
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02492724 on ClinicalTrials.gov