DiscopathyPMCF_MOVE®-CNCT05035693
Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C
A study testing MOVE®-C in people with Discopathy and Herniated Cervical Disc, run by NGMedical GmbH at 7 sites in 2 countries.
Trial summary
Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG. Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Discopathy, Herniated Cervical Disc, Stenoses, Spinal
- What is being tested?
- MOVE®-C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 11 Mar 2021to 11 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of discopathy or disc hernia with radiculopathy or stenosis of the foramen and spinal canal,
- documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated,
- no surgical treatment regarding the planned index surgery within the last six weeks prior implantation,
- unsuccessful conservative medical care regarding the indication within the last six weeks,
- age ≥18 years,
- patient must agree to fully participate in the clinical trial and give informed consent in writing,
- patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1),
- patient information has been provided and all written consents of the patient are available.
Who cannot join
- Known contraindication against the use of cervical intervertebral disc prostheses in accordance with the manufacturer's instructions for use:
- Bone mineral density with T-score ≤ -1.5 as determined by spine DXA if male ≥ 60 years of age or female ≥ 50 years of age,
- active systemic infection or infection at the operative site,
- sustained osteoporotic fracture of the spine, hip or wrist,
- spinal metastases,
- known allergy to titanium or polycarbonate-urethane,
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- confirmed pregnancy,
- severe cervical myelopathy,
- patients requiring a treatment that destabilises the spine (e.g. posterior element decompression),
- advanced cervical anatomical deformity at the operative site (e.g. ankylosing spondylitis, scoliosis),
- advanced degenerative changes (e.g. spondylosis) at the index vertebral level,
- patient is kept in an institution under judicial or official orders (MPG §20.3).
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Germany6 sites, 6 recruiting
- Recruiting
DRK Klinikum Berlin
Berlin, 14050
Olaf Süss, PD Dr.med., +493030354260, olaf.suess@drk-kliniken.de
Sven Mularski, Dr.med., +493030354260, sven.mularski@drk-kliniken.de
- Recruiting
Wirbelsäulenzentrum Fulda Main, Kinzig
Gelnhausen, 63571
Bernd Hölper, Dr. med., b.hölper@neuro-chirurgie.de
Yasmin Mitsikari, y.mitsikari@neuro-chirurgie.de
- Recruiting
Medizinisches Versorgungszentrum Steinburg
Itzehoe, 25524
Ardeshir Ardeshiri, Dr. med., 0049- 821-7726702, aardeshiri@aol.com
Lisa-Marie Feldhaus, 0049- 821-7726702, L.Feldhaus@KH-Itzehoe.de
- Recruiting
Katholisches Klinikum Koblenz - Montabaur
Koblenz, 56073
Francis K Kilian, Dr.med., 0049 261 496-6457, f.kilian@kk-km.de
Nina Schroeder, 0049 261 496-6457, n.schroeder@kk-km.de
- Recruiting
Neurochirurgie am Gasteig
München, 81669
Ardavan Ardeshiri, Dr. med., 0049 896666339040, ardeshiri@neurochirurgie-am-gasteig.de
Jenifer Kilian, 0049 896666339040, jkilian@neurochirurgie-am-gasteig.de
- Recruiting
Rhein-Maas Klinikum Würselen
Würselen, 52146
Rolf Sobottke, Prof.Dr.med., 0049 2405623372, rolf.sobottke@rheinmaasklinikum.de
Khaled Allan, 0049-2405-62-8258, allan.khaled@rheinmaasklinikum.de
Austria1 site, 1 recruiting
- Recruiting
Wiener Gesundheitsverbund-Klinik Penzing
Vienna, 1180
Ronald Sabitzer, OA, 0043 6767017974, ronald.sabitzer@gesundheitsverbund.de
About this study
Official title: "PMCF MOVE®-C" International, Prospective, Multicentre, Non-randomised Post-market Clinical Follow-up Study Clinical and Radiological Outcome After Mono- and Bisegmental Cervical Intervertebral Disc Prosthetics
Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG.
Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.
Read the detailed description
This clinical investigation is conducted to gain post market results on the Cervical Disc Prosthesis MOVE®-C and to demonstrate the safety and performance. Besides, it is aimed to gain knowledge concerning the development of patients' quality of life (QoL) after the implantation of the Cervical Disc Prosthesis MOVE®-C and to collect data for the analysis of the range of motion (ROM), which is an essential parameter for motion-preserving implants.
- Conditions
- Discopathy, Herniated Cervical Disc, Stenoses, Spinal, Radiculopathy
- Being tested
- MOVE®-C
- Keywords
- Herniated Disc, Cervical Spine, Discopathy, Radiculopathy
- Medical subject headings
- Spinal Stenosis, Radiculopathy, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVE®-CDevice
Also called cervical disc prothesis
Momo- or bisegmental implantation of MOVE®-C cervical prothesis.
| Study group | Role | What they receive |
|---|---|---|
| PMCF MOVE-C | Experimental | PMCF MOVE®_C is a single arm observational study with 170 patients. Receives: Device: MOVE®-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement from baseline on Neck Disability Index (NDI)
Primary outcome measure 1 and 2 are combined endpoints. Improvement of the NDI of more than 15 points for a change (pre-postoperative) of up to 30 points with a standard deviation of 25 points.
Measured: Baseline and month 24
Improvement from baseline on Visual Analogue Scales (VAS arm/neck)
Primary outcome measure 1 and 2 are combined endpoints. Improvement of arm and neck pain scale (VAS arm/neck) of more than 2 points at a change (pre-postoperative) of 2.7 points with a standard deviation of 2.5 points.
Measured: Baseline and month 24
Secondary outcomes (6)
Change from baseline in Core Outcome Measure Index (COMI neck)
The clinical results of COMI neck will be compared to the 24 months visit before the operation.
Measured: Baseline and months 24
Change from baseline in Short Form 36 Health Survey Questionnaire (SF-36)
The clinical results of SF-36 will be compared to the 24 months visit before the operation.
Measured: Baseline and moths 24
Change from baseline in EuroQoL (EQ-5D-5L)
The clinical results of (EQ-5D-5L) will be compared to the 24 months visit before the operation.
Measured: Baseline and moths 24
Change from baseline in Japanese Orthopedic Association Score (JOA)
The clinical results of (JOA) will be compared to the 24 months visit before the operation.
Measured: Baseline and moths 24
Analyse of the Range of Motion (ROM)
The radiological results of the ROM are compared to the 24 months visit before the operation.
Measured: Baseline and moths 24
Monitoring of product related occurence of adverse events (AE-Monitoring)
The radiological results of the AE-Monitoring are compared to the 24 months visit before the operation.
Measured: Baseline and moths 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start11 Mar 2021
- Primary completion11 Mar 2025 (estimated)
- Study completion11 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiscopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NGMedical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olaf Süss, PD Dr. med., Principal investigator, DRK Kliniken Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035693
- Sponsor's protocol ID
- P004
- Other IDs
- DRKS00022971
- Acronym
- PMCF_MOVE®-C
- Status last verified
- Nov 2024
- First submitted
- 12 Mar 2021
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be available for other researchers, that will not be a study site in this clinical trial.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "PMCF MOVE®-C" International, Prospective, Multicentre, Non-randomised Post-market Clinical Follow-up Study Clinical and Radiological Outcome After Mono- and Bisegmental Cervical Intervertebral Disc Prosthetics
- ClinicalTrials.gov ID
- NCT05035693
- Acronym / sponsor ID
- PMCF_MOVE®-C / P004
- Conditions
- Discopathy, Herniated Cervical Disc, Stenoses, Spinal, Radiculopathy
- Keywords
- Herniated Disc, Cervical Spine, Discopathy, Radiculopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- NGMedical GmbHIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 11 Mar 2025 (estimated)
- Study completion
- 11 Mar 2027 (estimated)
- First posted
- 5 Sep 2021 (actual)
- 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.
Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG.
Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.
Detailed description
This clinical investigation is conducted to gain post market results on the Cervical Disc Prosthesis MOVE®-C and to demonstrate the safety and performance. Besides, it is aimed to gain knowledge concerning the development of patients' quality of life (QoL) after the implantation of the Cervical Disc Prosthesis MOVE®-C and to collect data for the analysis of the range of motion (ROM), which is an essential parameter for motion-preserving implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PMCF MOVE-C | Experimental | Device: MOVE®-CPMCF MOVE®_C is a single arm observational study with 170 patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of discopathy or disc hernia with radiculopathy or stenosis of the foramen and spinal canal,
- documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated,
- no surgical treatment regarding the planned index surgery within the last six weeks prior implantation,
- unsuccessful conservative medical care regarding the indication within the last six weeks,
- age ≥18 years,
Key exclusion criteria (12 listed)
- Known contraindication against the use of cervical intervertebral disc prostheses in accordance with the manufacturer's instructions for use:
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 |
|---|---|---|
| MOVE®-CAlso: cervical disc prothesisMomo- or bisegmental implantation of MOVE®-C cervical prothesis. | Device | PMCF MOVE-C |
Primary outcome
Improvement from baseline on Neck Disability Index (NDI)
Time frame: Baseline and month 24
Primary outcome measure 1 and 2 are combined endpoints. Improvement of the NDI of more than 15 points for a change (pre-postoperative) of up to 30 points with a standard deviation of 25 points.
Improvement from baseline on Visual Analogue Scales (VAS arm/neck)
Time frame: Baseline and month 24
Primary outcome measure 1 and 2 are combined endpoints. Improvement of arm and neck pain scale (VAS arm/neck) of more than 2 points at a change (pre-postoperative) of 2.7 points with a standard deviation of 2.5 points.
6 secondary outcomes
Change from baseline in Core Outcome Measure Index (COMI neck)
Time frame: Baseline and months 24
Change from baseline in Short Form 36 Health Survey Questionnaire (SF-36)
Time frame: Baseline and moths 24
Change from baseline in EuroQoL (EQ-5D-5L)
Time frame: Baseline and moths 24
Change from baseline in Japanese Orthopedic Association Score (JOA)
Time frame: Baseline and moths 24
Analyse of the Range of Motion (ROM)
Time frame: Baseline and moths 24
Monitoring of product related occurence of adverse events (AE-Monitoring)
Time frame: Baseline and moths 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No. No IPD will be available for other researchers, that will not be a study site in this clinical trial.
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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.
Olaf Süss, PD Dr. med. principal investigator
DRK Kliniken Berlin
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOVE®-C in people with Discopathy and Herniated Cervical Disc, run by NGMedical GmbH at 7 sites in 2 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 12 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: looking for participants now, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saskia Mathieu, M.Sc. (+49687399997118, smathieu@ngmedical.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement from baseline on Neck Disability Index (NDI) (time frame: Baseline and month 24). 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?
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 15 Nov 2024.