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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00868335
Other study ID # CWK-Tracking01
Secondary ID
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


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
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