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

Intervertebral Disk Displacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868335
• Other study ID #: CWK-Tracking01
• Status: Completed
• Phase: N/A
• First received: March 23, 2009
• Last updated: March 20, 2016
• Start date: December 2007
• Est. completion date: October 2015

Study information

• Verified date: March 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diskectomy
• Intervertebral Disc Displacement
• Intervertebral Disk Displacement

Intervention

Device:
• Activ C disc prosthesis
cervical disc prosthesis

Procedure:
• Anterior cervical discectomy
Removal of protruding cervical disc through an anterior approach

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	B. Braun/Aesculap Spine

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Order of movement		baseline, 3 months, 12 months	No
Primary	Segmental mobility		Baseline, 3 months, 12 months	No
Secondary	Treatment of symptoms (pain, neurological assessment)		Baseline, 3 months, 12 months	No
Secondary	Influence on subjects functioning (social, work)		Baseline, 3 months, 12 months	No