Back to resultsPost Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C (PMCF_MOVE®-C)
Primary Purpose
Discopathy, Herniated Cervical Disc, Stenoses, Spinal
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MOVE®-C
Sponsored by
About this trial
This is an interventional treatment trial for Discopathy focused on measuring Herniated Disc, Cervical Spine, Discopathy, Radiculopathy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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,
- 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).
Sites / Locations
- Wiener Gesundheitsverbund-Klinik PenzingRecruiting
- DRK Klinikum BerlinRecruiting
- Wirbelsäulenzentrum Fulda Main, KinzigRecruiting
- Medizinisches Versorgungszentrum SteinburgRecruiting
- Katholisches Klinikum Koblenz - MontabaurRecruiting
- Neurochirurgie am GasteigRecruiting
- Rhein-Maas Klinikum WürselenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PMCF MOVE-C
Arm Description
PMCF MOVE®_C is a single arm observational study with 170 patients.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Analyse of the Range of Motion (ROM)
The radiological results of the ROM are compared to the 24 months visit before the operation.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05035693
Brief Title
Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C
Acronym
PMCF_MOVE®-C
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 Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
March 11, 2024 (Anticipated)
Study Completion Date
March 11, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NGMedical GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discopathy, Herniated Cervical Disc, Stenoses, Spinal, Radiculopathy
Keywords
Herniated Disc, Cervical Spine, Discopathy, Radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PMCF MOVE-C
Arm Type
Experimental
Arm Description
PMCF MOVE®_C is a single arm observational study with 170 patients.
Intervention Type
Device
Intervention Name(s)
MOVE®-C
Other Intervention Name(s)
cervical disc prothesis
Intervention Description
Momo- or bisegmental implantation of MOVE®-C cervical prothesis.
Primary Outcome Measure Information:
Title
Improvement from baseline on Neck Disability Index (NDI)
Description
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.
Time Frame
Baseline and month 24
Title
Improvement from baseline on Visual Analogue Scales (VAS arm/neck)
Description
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.
Time Frame
Baseline and month 24
Secondary Outcome Measure Information:
Title
Change from baseline in Core Outcome Measure Index (COMI neck)
Description
The clinical results of COMI neck will be compared to the 24 months visit before the operation.
Time Frame
Baseline and months 24
Title
Change from baseline in Short Form 36 Health Survey Questionnaire (SF-36)
Description
The clinical results of SF-36 will be compared to the 24 months visit before the operation.
Time Frame
Baseline and moths 24
Title
Change from baseline in EuroQoL (EQ-5D-5L)
Description
The clinical results of (EQ-5D-5L) will be compared to the 24 months visit before the operation.
Time Frame
Baseline and moths 24
Title
Change from baseline in Japanese Orthopedic Association Score (JOA)
Description
The clinical results of (JOA) will be compared to the 24 months visit before the operation.
Time Frame
Baseline and moths 24
Title
Analyse of the Range of Motion (ROM)
Description
The radiological results of the ROM are compared to the 24 months visit before the operation.
Time Frame
Baseline and moths 24
Title
Monitoring of product related occurence of adverse events (AE-Monitoring)
Description
The radiological results of the AE-Monitoring are compared to the 24 months visit before the operation.
Time Frame
Baseline and moths 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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,
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saskia Mathieu, M.Sc.
Phone
+49687399997118
Email
smathieu@ngmedical.de
First Name & Middle Initial & Last Name or Official Title & Degree
Nino Weiland, B.Sc.
Phone
+49687399997104
Email
nweiland@ngmedical.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olaf Süss, PD Dr. med.
Organizational Affiliation
DRK Kliniken Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wiener Gesundheitsverbund-Klinik Penzing
City
Wien
ZIP/Postal Code
1180
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Sabitzer, OA
Phone
0043 6767017974
Email
ronald.sabitzer@gesundheitsverbund.de
Facility Name
DRK Klinikum Berlin
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olaf Süss, PD Dr.med.
Phone
+493030354260
Email
olaf.suess@drk-kliniken.de
First Name & Middle Initial & Last Name & Degree
Sven Mularski, Dr.med.
Phone
+493030354260
Email
sven.mularski@drk-kliniken.de
First Name & Middle Initial & Last Name & Degree
Björn Kühn, Dr. med.
First Name & Middle Initial & Last Name & Degree
Thomas Langer, Dr.med
Facility Name
Wirbelsäulenzentrum Fulda Main, Kinzig
City
Gelnhausen
ZIP/Postal Code
63571
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernd Hölper, Dr. med.
Email
b.hölper@neuro-chirurgie.de
First Name & Middle Initial & Last Name & Degree
Yasmin Mitsikari
Email
y.mitsikari@neuro-chirurgie.de
Facility Name
Medizinisches Versorgungszentrum Steinburg
City
Itzehoe
ZIP/Postal Code
25524
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ardeshir Ardeshiri, Dr. med.
Phone
0049- 821-7726702
Email
aardeshiri@aol.com
First Name & Middle Initial & Last Name & Degree
Lisa-Marie Feldhaus
Phone
0049- 821-7726702
Email
L.Feldhaus@KH-Itzehoe.de
Facility Name
Katholisches Klinikum Koblenz - Montabaur
City
Koblenz
ZIP/Postal Code
56073
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis K Kilian, Dr.med.
Phone
0049 261 496-6457
Email
f.kilian@kk-km.de
First Name & Middle Initial & Last Name & Degree
Nina Schroeder
Phone
0049 261 496-6457
Email
n.schroeder@kk-km.de
First Name & Middle Initial & Last Name & Degree
Bernhard Bruchmann, Dr.med.
Facility Name
Neurochirurgie am Gasteig
City
München
ZIP/Postal Code
81669
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ardavan Ardeshiri, Dr. med.
Phone
0049 896666339040
Email
ardeshiri@neurochirurgie-am-gasteig.de
First Name & Middle Initial & Last Name & Degree
Jenifer Kilian
Phone
0049 896666339040
Email
jkilian@neurochirurgie-am-gasteig.de
Facility Name
Rhein-Maas Klinikum Würselen
City
Würselen
ZIP/Postal Code
52146
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rolf Sobottke, Prof.Dr.med.
Phone
0049 2405623372
Email
rolf.sobottke@rheinmaasklinikum.de
First Name & Middle Initial & Last Name & Degree
Khaled Allan
Phone
0049-2405-62-8258
Email
allan.khaled@rheinmaasklinikum.de
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be available for other researchers, that will not be a study site in this clinical trial.
Learn more about this trial
Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C
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