NCT00868335

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

7.8 years

First QC Date

March 23, 2009

Last Update Submit

March 20, 2016

Conditions

DiskectomyIntervertebral Disk Displacement

Keywords

Cervical degenerative disc diseaseAnterior cervical discectomyCervical disc prosthesisActiv-CMobilityMovement

Outcome Measures

Primary Outcomes (2)

  • Order of movement

    baseline, 3 months, 12 months

  • Segmental mobility

    Baseline, 3 months, 12 months

Secondary Outcomes (2)

  • Treatment of symptoms (pain, neurological assessment)

    Baseline, 3 months, 12 months

  • Influence on subjects functioning (social, work)

    Baseline, 3 months, 12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Anterior cervical discectomy, no disc prosthesis

Procedure: Anterior cervical discectomy

2

EXPERIMENTAL

Anterior cervical discectomy, with disc prosthesis

Device: Activ C disc prosthesisProcedure: Anterior cervical discectomy

Interventions

Activ C disc prosthesisDEVICE

cervical disc prosthesis

Also known as: Activ C cervical disc prosthesis, B.Braun/Aesculap Spine
2
Anterior cervical discectomyPROCEDURE

Removal of protruding cervical disc through an anterior approach

12

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 25887569DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • H van Santbrink, MD, PhD

    Department of Neurosurgery, Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 23, 2009

First Posted

March 24, 2009

Study Start

December 1, 2007

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations

NL(1)