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Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis

Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without an Activ-C Cervical Disc Prosthesis.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00868335
Enrollment
24
Registered
2009-03-24
Start date
2007-12-31
Completion date
2015-10-31
Last updated
2016-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diskectomy, Intervertebral Disk Displacement

Keywords

Cervical degenerative disc disease, Anterior cervical discectomy, Cervical disc prosthesis, Activ-C, Mobility, Movement

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. 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.

Interventions

DEVICEActiv C disc prosthesis

cervical disc prosthesis

PROCEDUREAnterior cervical discectomy

Removal of protruding cervical disc through an anterior approach

Sponsors

B. Braun/Aesculap Spine
CollaboratorUNKNOWN
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Order of movementbaseline, 3 months, 12 months
Segmental mobilityBaseline, 3 months, 12 months

Secondary

MeasureTime frame
Treatment of symptoms (pain, neurological assessment)Baseline, 3 months, 12 months
Influence on subjects functioning (social, work)Baseline, 3 months, 12 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026