Intervertebral Disc ReplacementNCT02492724
Activ C European Multicenter Study
An observational study of Intervertebral Disc Replacement and Degenerative Disc Disease, run by Aesculap AG at 10 sites in 5 countries.
Trial summary
Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who suffer from cervical symptomatic degenerative disc disease. A maximum of 200 cases will be enrolled into the study. An 18-month recruitment period is planned with a 4-year postoperative follow-up period for each subject. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intervertebral Disc Replacement, Degenerative Disc Disease
- How many people
- 210 participants
- Where
- 10 sitesin 5 countries
- Study dates
- Feb 2007to Dec 2013
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- Symptomatic single-level cervical degenerative disc disease with neck and/or arm
- pain and/or neurological deficit, confirmed by MR scan
- Single-level surgery and single-level implantation of prosthesis between C3 and C7
- Age between 18 - 65 years at the time of surgery
- Pre-operative disc space height of the segment to be operated of at least 3mm
- Unsuccessful adequate conservative treatment
- Patient understands the conditions of the study and is willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
- Patient signed Informed Consent
Who cannot join
- Major facet joint degeneration at the segment to be operated on
- Severe spondylosis at the segment to be operated on (bridging osteophytes, absence of motion (<2°))
- Pre-operative disc space height of the segment to be operated on of less than 3mm
- Major cervical segmental instability at the segment to be operated on (translation ≥3,5 mm and/or ≥11° of rotational difference to that of either adjacent level)
- Previous trauma to the segment to be operated on resulting in compression or bursting
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Germany4 sites
Charité Berlin
Berlin, 10709
Berufsgenossenschaftliche Kliniken Bergmannstrost
Halle, 06112
Katholisches Klinikum Koblenz
Koblenz, 56073
Universität Rostock, Abteilung Neurochirurgie
Rostock, 18057
Czechia3 sites
Regional Hospital Liberec
Liberec, 46063
Faculty Hospital Motol Prague
Prague, 150 06
University Hospital Motol
Prague, 16000
United Kingdom1 site
Warrington District General Hospital
Warrington, WA4 4LU
About this study
Official title: Activ C Disc Prosthesis European Multi-Center Clinical Investigation
Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who suffer from cervical symptomatic degenerative disc disease. A maximum of 200 cases will be enrolled into the study. An 18-month recruitment period is planned with a 4-year postoperative follow-up period for each subject. Thus, it is anticipated that the study will require a minimum of 5.5 years. Patients will be assessed preoperatively, intraoperatively, prior to discharge and again at 6 weeks, 6 months, 1 year, 2 years and 4 years postoperatively from the date of surgery.
Read the detailed description
The activ C Disc Prosthesis pursues the goal of restoring the disc function, the geometry and motion of the cervical disc. Its concept is based on a ball and socket joint, anchored between adjacent vertebral bodies. The modular prosthesis comprises the following elements: an inferior CoCr plate component anchored in the endplate of the caudal vertebral body. The UHMWPE inlay is securely fixed in this inferior component. The second element is the superior CoCr component, which is anchored in the end plate of the cranial vertebral body. It forms a ball joint with the inlay of the inferior plate component.
The activ C product range enables reconstruction of various disc heights as well as adaptation to the end plate sizes. Secure primary anchorage of the prosthesis to the vertebral bodies is achieved by convexly shaped superior end pla tes and fixation means (spikes and grooves on the superior end plate, a small keel on the inferior end plate), whereas secondary stability is facilitated by an osseointegrative Plasmapore® coating.
The objective of the study is to collect outcome information on the Activ® C Disc Prosthesis.
- Keywords
- cervical spine, total disc replacement (cTDR), degenerative disc disease, activ® C, clinical outcome, long-term results, NDI, VAS, heterotopic ossification (HO), range of motion (ROM), adjacent segment degeneration
- Medical subject headings
- Intervertebral Disc Degeneration, Ossification, Heterotopic
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome measured by the Neck Disability Index (NDI)
The primary endpoint of the study will be changes in the clinical outcome measured by the Neck Disability Index (NDI) as published by Vernon et. al.
Measured: 4 years
Secondary outcomes (6)
Visual Analogue Scale (VAS) on severity of neck pain and arm pain (experienced in the pain-dominant arm)
Measured: 4 years
Visual Analogue Scale (VAS) on frequency of neck pain and arm pain (experienced in the pain-dominant arm)
Measured: 4 years
Adjacent segment degeneration
Measured: 4 years
Postoperative angular motion on flexion/extension radiographs in the replaced segment
Measured: 4 years
Complication rates (device related and non-device related)
Measured: 4 years
Overall success rate
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startFeb 2007
- Primary completionDec 2009
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intervertebral Disc ReplacementStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petr Suchomel, MD PhD, Principal investigator, Neurocentre, Regional Hospital Liberec, Liberec, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492724
- Sponsor's protocol ID
- AAG-O-H-0707
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2015
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Suchomel P, Jurak L, Antinheimo J, Pohjola J, Stulik J, Meisel HJ, Cabraja M, Woiciechowsky C, Bruchmann B, Shackleford I, Arregui R, Sola S. Does sagittal position of the CTDR-related centre of rotation influence functional outcome? Prospective 2-year follow-up analysis. Eur Spine J. 2014 May;23(5):1124-34. doi: 10.1007/s00586-014-3223-0. Epub 2014 Feb 20.
PubMed 24554334Meisel HJ, Jurak L, Antinheimo J, Arregui R, Bruchmann B, Cabraja M, Caroli F, Kroppenstedt S, Kryl J, Pohjola J, Shackleford I, Sola S, Stosberg P, Stulik J, Woiciechowsky C, Suchomel P. Four-year results of a prospective single-arm study on 200 semi-constrained total cervical disc prostheses: clinical and radiographic outcome. J Neurosurg Spine. 2016 Nov;25(5):556-565. doi: 10.3171/2016.3.SPINE15810. Epub 2016 Jun 3.
PubMed 27258476
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activ C Disc Prosthesis European Multi-Center Clinical Investigation
- ClinicalTrials.gov ID
- NCT02492724
- Acronym / sponsor ID
- AAG-O-H-0707
- Keywords
- cervical spine, total disc replacement (cTDR), degenerative disc disease, activ® C, clinical outcome, long-term results, NDI, VAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Jul 2015 (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.
Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who suffer from cervical symptomatic degenerative disc disease. A maximum of 200 cases will be enrolled into the study. An 18-month recruitment period is planned with a 4-year postoperative follow-up period for each subject. Thus, it is anticipated that the study will require a minimum of 5.5 years. Patients will be assessed preoperatively, intraoperatively, prior to discharge and again at 6 weeks, 6 months, 1 year, 2 years and 4 years postoperatively from the date of surgery.
Detailed description
The activ C Disc Prosthesis pursues the goal of restoring the disc function, the geometry and motion of the cervical disc. Its concept is based on a ball and socket joint, anchored between adjacent vertebral bodies. The modular prosthesis comprises the following elements: an inferior CoCr plate component anchored in the endplate of the caudal vertebral body. The UHMWPE inlay is securely fixed in this inferior component. The second element is the superior CoCr component, which is anchored in the end plate of the cranial vertebral body. It forms a ball joint with the inlay of the inferior plate component.
The activ C product range enables reconstruction of various disc heights as well as adaptation to the end plate sizes. Secure primary anchorage of the prosthesis to the vertebral bodies is achieved by convexly shaped superior end pla tes and fixation means (spikes and grooves on the superior end plate, a small keel on the inferior end plate), whereas secondary stability is facilitated by an osseointegrative Plasmapore® coating.
The objective of the study is to collect outcome information on the Activ® C Disc Prosthesis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (8 listed)
- Symptomatic single-level cervical degenerative disc disease with neck and/or arm
- pain and/or neurological deficit, confirmed by MR scan
- Single-level surgery and single-level implantation of prosthesis between C3 and C7
- Age between 18 - 65 years at the time of surgery
- Pre-operative disc space height of the segment to be operated of at least 3mm
Key exclusion criteria (5 listed)
- Major facet joint degeneration at the segment to be operated on
- Severe spondylosis at the segment to be operated on (bridging osteophytes, absence of motion (<2°))
- Pre-operative disc space height of the segment to be operated on of less than 3mm
- Major cervical segmental instability at the segment to be operated on (translation ≥3,5 mm and/or ≥11° of rotational difference to that of either adjacent level)
- Previous trauma to the segment to be operated on resulting in compression or bursting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Outcome measured by the Neck Disability Index (NDI)
Time frame: 4 years
The primary endpoint of the study will be changes in the clinical outcome measured by the Neck Disability Index (NDI) as published by Vernon et. al.
6 secondary outcomes
Visual Analogue Scale (VAS) on severity of neck pain and arm pain (experienced in the pain-dominant arm)
Time frame: 4 years
Visual Analogue Scale (VAS) on frequency of neck pain and arm pain (experienced in the pain-dominant arm)
Time frame: 4 years
Adjacent segment degeneration
Time frame: 4 years
Postoperative angular motion on flexion/extension radiographs in the replaced segment
Time frame: 4 years
Complication rates (device related and non-device related)
Time frame: 4 years
Overall success rate
Time frame: 4 years
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 9 Jul 2015.
- Results publication: PubMed 24554334Suchomel P, Jurak L, Antinheimo J, Pohjola J, Stulik J, Meisel HJ, Cabraja M, Woiciechowsky C, Bruchmann B, Shackleford I, Arregui R, Sola S. Does sagittal position of the CTDR-related centre of rotation influence functional outcome? Prospective 2-year follow-up analysis. Eur Spine J. 2014 May;23(5):1124-34. doi: 10.1007/s00586-014-3223-0. Epub 2014 Feb 20.
- Derived from this study: PubMed 27258476Meisel HJ, Jurak L, Antinheimo J, Arregui R, Bruchmann B, Cabraja M, Caroli F, Kroppenstedt S, Kryl J, Pohjola J, Shackleford I, Sola S, Stosberg P, Stulik J, Woiciechowsky C, Suchomel P. Four-year results of a prospective single-arm study on 200 semi-constrained total cervical disc prostheses: clinical and radiographic outcome. J Neurosurg Spine. 2016 Nov;25(5):556-565. doi: 10.3171/2016.3.SPINE15810. Epub 2016 Jun 3.
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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.
Petr Suchomel, MD PhD principal investigator
Neurocentre, Regional Hospital Liberec, Liberec, Czech Republic
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Replacement and Degenerative Disc Disease, run by Aesculap AG at 10 sites in 5 countries.
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 8 inclusion and 5 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 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Czechia, Finland, Italy, United Kingdom. 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?
Clinical Outcome measured by the Neck Disability Index (NDI) (time frame: 4 years). 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 NCT02492724, which also lists 2 linked publications.
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 9 Jul 2015.