Status:
COMPLETED
Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
B. Braun/Aesculap Spine
Conditions:
Diskectomy
Intervertebral Disk Displacement
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The purpose of this study is to find out if use of a cervical disc prosthesis in the treatment of a cervical disc herniation preserves or restores normal mobility and movement in the cervical spine.
Detailed Description
Intractable nerve pain to the arm caused by a cervical disc herniation is typically treated by removal of the protruding disc through an operation. Fusion of the discs follows in about 70% of cases. ...
Eligibility Criteria
Inclusion
- indication for anterior cervical discectomy
- monoradicular syndrome caused by compression at C5-6 or C6-7
- monosegmental disease on MRI
- able to actively perform flexion/extension movement
- segmental mobility on the afflicted level \>2 degrees of rotation
- informed consent
Exclusion
- previous operative interventions on the cervical spine
- multiple segments afflicted
- positive L'Hermittes sing
- Active infection
- Immature bone
- Tumorous processes in the cervical region
- Previous radiation therapy in the cervical region
- Pregnancy
- Cervical myelopathy
- not able to speak Dutch
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00868335
Start Date
December 1 2007
End Date
October 1 2015
Last Update
March 22 2016
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX