Intervertebral Disk Displacement Clinical Trial
Official title:
Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without an Activ-C Cervical Disc Prosthesis.
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | B. Braun/Aesculap Spine |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Order of movement | baseline, 3 months, 12 months | No | |
Primary | Segmental mobility | Baseline, 3 months, 12 months | No | |
Secondary | Treatment of symptoms (pain, neurological assessment) | Baseline, 3 months, 12 months | No | |
Secondary | Influence on subjects functioning (social, work) | Baseline, 3 months, 12 months | No |
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