DiskectomyNCT00868335
Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis
A study testing Activ C disc prosthesis and Anterior cervical discectomy in people with Diskectomy and Intervertebral Disk Displacement, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diskectomy, Intervertebral Disk Displacement
- What is being tested?
- Activ C disc prosthesis and Anterior cervical discectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2007to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- previous operative interventions on the cervical spine
- multiple segments afflicted
- positive L'Hermittes sing
- Active infection
- Immature bone
- Tumorous processes in the cervical region
Show all 10Show fewer
- Previous radiation therapy in the cervical region
- Pregnancy
- Cervical myelopathy
- not able to speak Dutch
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
About this study
Official title: 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.
Read the 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.
- Conditions
- Diskectomy, Intervertebral Disk Displacement
- Being tested
- Activ C disc prosthesis, Anterior cervical discectomy
- Keywords
- Cervical degenerative disc disease, Anterior cervical discectomy, Cervical disc prosthesis, Activ-C, Mobility, Movement
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activ C disc prosthesisDevice
Also called Activ C cervical disc prosthesis, B.Braun/Aesculap Spine
cervical disc prosthesis
Anterior cervical discectomyProcedure or surgery
Removal of protruding cervical disc through an anterior approach
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Anterior cervical discectomy, no disc prosthesis Receives: Procedure: Anterior cervical discectomy |
| 2 | Experimental | Anterior cervical discectomy, with disc prosthesis Receives: Device: Activ C disc prosthesis; Procedure: Anterior cervical discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Order of movement
Measured: baseline, 3 months, 12 months
Segmental mobility
Measured: Baseline, 3 months, 12 months
Secondary outcomes (2)
Treatment of symptoms (pain, neurological assessment)
Measured: Baseline, 3 months, 12 months
Influence on subjects functioning (social, work)
Measured: Baseline, 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startDec 2007
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiskectomyStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun/Aesculap Spine
- Responsible party
- Principal investigator, Toon Boselie, Maastricht University Medical Center
- Investigators
- H van Santbrink, MD, PhD, Principal investigator, Department of Neurosurgery, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868335
- Sponsor's protocol ID
- CWK-Tracking01
- Status last verified
- Mar 2016
- First submitted
- 23 Mar 2009
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25887569
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without an Activ-C Cervical Disc Prosthesis.
- ClinicalTrials.gov ID
- NCT00868335
- Acronym / sponsor ID
- CWK-Tracking01
- Conditions
- Diskectomy, Intervertebral Disk Displacement
- Keywords
- Cervical degenerative disc disease, Anterior cervical discectomy, Cervical disc prosthesis, Activ-C, Mobility, Movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- B. Braun/Aesculap Spine
- Study start
- Dec 2007
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Anterior cervical discectomyAnterior cervical discectomy, no disc prosthesis |
| 2 | Experimental | Device: Activ C disc prosthesis, Procedure: Anterior cervical discectomyAnterior cervical discectomy, with disc prosthesis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- previous operative interventions on the cervical spine
- multiple segments afflicted
- positive L'Hermittes sing
- Active infection
- Immature bone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activ C disc prosthesisAlso: Activ C cervical disc prosthesis, B.Braun/Aesculap Spinecervical disc prosthesis | Device | 2 |
| Anterior cervical discectomyRemoval of protruding cervical disc through an anterior approach | Procedure or surgery | 1, 2 |
Primary outcome
Order of movement
Time frame: baseline, 3 months, 12 months
Segmental mobility
Time frame: Baseline, 3 months, 12 months
2 secondary outcomes
Treatment of symptoms (pain, neurological assessment)
Time frame: Baseline, 3 months, 12 months
Influence on subjects functioning (social, work)
Time frame: Baseline, 3 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Derived from this study: PubMed 25887569Boselie 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.
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Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H van Santbrink, MD, PhD principal investigator
Department of Neurosurgery, Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activ C disc prosthesis and Anterior cervical discectomy in people with Diskectomy and Intervertebral Disk Displacement, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Order of movement (time frame: baseline, 3 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00868335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.