Status:
COMPLETED
PRESTIGE Observational Study
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Degenerative Cervical Disc Disease
Eligibility:
All Genders
18+ years
Brief Summary
Prestige artificial disc replacement is an alternative treatment option with 16 years of experience addressing the unmet needs of surgical fusion interventions. Previous studies on the PRESTIGE® cervi...
Detailed Description
Degenerative cervical disc disease is associated with a very high burden to the patient and the society. If conservative treatment options fail, surgical interventions are the last treatment option. ...
Eligibility Criteria
Inclusion
- Patient must be willing to sign a Patient Data Release Form.
- Patient with degenerative disc disease (DDD) who is scheduled to receive a PRESTIGE® Cervical Disc and fulfills the indications according to the product description.
Exclusion
- Patient fulfills any contraindication according to the product description.
- Patient has not reached the age of legal consent according to local laws.
- Patient has diabetes.
- Patient has Body Mass Index (BMI) \> 35.
- Patient has affected disc not between C3/C4 and C6/C7.
- Patient with instability of cervical spine.
- Patients who will receive extensive decompression.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00875810
Start Date
April 1 2008
End Date
November 1 2013
Last Update
January 28 2016
Active Locations (26)
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1
Hospital Plzen - Lochotin
Pilsen, Czechia, 32318
2
Hospital Plzen - Lochotin
Pilsen, Czechia
3
University Clinic Motol
Prague, Czechia
4
Agia Olga Hospital
Athens, Greece