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

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Diskectomy
Intervertebral Disk Displacement

Treatments

Procedure: Anterior cervical discectomy
Device: Activ C disc prosthesis

Study type

Interventional

Funder types

Other

Identifiers

NCT00868335
CWK-Tracking01

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

1
Active Comparator group
Description:
Anterior cervical discectomy, no disc prosthesis
Treatment:
Procedure: Anterior cervical discectomy
2
Experimental group
Description:
Anterior cervical discectomy, with disc prosthesis
Treatment:
Device: Activ C disc prosthesis
Procedure: Anterior cervical discectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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