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.

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.

Study Overview

• Status: Completed
• Conditions: Intervertebral Disk Displacement; Diskectomy
• Intervention / Treatment: Procedure: Anterior cervical discectomy; Device: Activ C disc prosthesis

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Anterior cervical discectomy, no disc prosthesis	Procedure: Anterior cervical discectomy; Removal of protruding cervical disc through an anterior approach
Experimental: 2; Anterior cervical discectomy, with disc prosthesis	Procedure: Anterior cervical discectomy; Removal of protruding cervical disc through an anterior approach; Device: Activ C disc prosthesis; cervical disc prosthesis; Other Names: Activ C cervical disc prosthesis, B.Braun/Aesculap Spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Order of movement	baseline, 3 months, 12 months
Segmental mobility	Baseline, 3 months, 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment of symptoms (pain, neurological assessment)	Baseline, 3 months, 12 months
Influence on subjects functioning (social, work)	Baseline, 3 months, 12 months

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: B. Braun/Aesculap Spine
• Investigators: Principal Investigator: H van Santbrink, MD, PhD, Department of Neurosurgery, Maastricht University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: March 23, 2009
• First Submitted That Met QC Criteria: March 23, 2009
• First Posted (Estimate): March 24, 2009

Study Record Updates

• Last Update Posted (Estimate): March 22, 2016
• Last Update Submitted That Met QC Criteria: March 20, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Mobility; Movement; Cervical degenerative disc disease; Anterior cervical discectomy; Cervical disc prosthesis; Activ-C
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: CWK-Tracking01