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OpenTrials
Completed

NCT Number: NCT00868335

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activ C disc prosthesis

Device

cervical disc prosthesis

Other names: Activ C cervical disc prosthesis, B.Braun/Aesculap Spine

Anterior cervical discectomy

Procedure

Removal of protruding cervical disc through an anterior approach

Primary outcomes

  1. Order of movement

    Time frame: baseline, 3 months, 12 months

  2. Segmental mobility

    Time frame: Baseline, 3 months, 12 months

Secondary outcomes

  1. Treatment of symptoms (pain, neurological assessment)

    Time frame: Baseline, 3 months, 12 months

  2. Influence on subjects functioning (social, work)

    Time frame: Baseline, 3 months, 12 months

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • B. Braun/Aesculap Spine

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Mar 24, 2009
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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