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| Name | Class |
|---|---|
| B. Braun/Aesculap Spine | UNKNOWN |
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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.
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.
Adjacent disc disease (ADD), symptomatic degenerative changes in the levels adjacent to the operated level is regarded as a late complication. Fusion at the operated level is thought to contribute to this process due to compensative increased mobility and stress on the adjacent segments.
Keeping the operated segment mobile through the use of a cervical disc prosthesis possibly prevents ADD.
We hypothesize that use of a cervical disc prosthesis preserves or restores normal mobility to the cervical spine. To test this hypothesis subjects are randomised in a group receiving a standard anterior cervical discectomy, and a group receiving a standard discectomy with placement of a cervical disc prosthesis. Digital X-ray cinematographic videos are made of a flexion/extension movement. The videos will be analyzed manually and through a newly designed automated program, to check for mobility and order of movement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Anterior cervical discectomy, no disc prosthesis |
|
| 2 | Experimental | Anterior cervical discectomy, with disc prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activ C disc prosthesis | Device | cervical disc prosthesis |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Order of movement | baseline, 3 months, 12 months | |
| Segmental mobility | Baseline, 3 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment of symptoms (pain, neurological assessment) | Baseline, 3 months, 12 months | |
| Influence on subjects functioning (social, work) | Baseline, 3 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H van Santbrink, MD, PhD | Department of Neurosurgery, Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6229 HX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25887569 | Derived | Boselie TF, van Mameren H, de Bie RA, van Santbrink H. Cervical spine kinematics after anterior cervical discectomy with or without implantation of a mobile cervical disc prosthesis; an RCT. BMC Musculoskelet Disord. 2015 Feb 21;16:34. doi: 10.1186/s12891-015-0479-4. |
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| Anterior cervical discectomy | Procedure | Removal of protruding cervical disc through an anterior approach |
|
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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