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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Momo- or bisegmental implantation of MOVE®-C cervical prothesis.
Wiener Gesundheitsverbund-Klinik Penzing
Vienna, Austria
RECRUITINGDRK Klinikum Berlin
Berlin, Germany
RECRUITINGWirbelsäulenzentrum Fulda Main, Kinzig
Gelnhausen, Germany
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.
Time frame: 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.
Time frame: Baseline and month 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and moths 24
Analyse of the Range of Motion (ROM)
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Medizinisches Versorgungszentrum Steinburg
Itzehoe, Germany
RECRUITINGKatholisches Klinikum Koblenz - Montabaur
Koblenz, Germany
RECRUITINGNeurochirurgie am Gasteig
München, Germany
RECRUITINGRhein-Maas Klinikum Würselen
Würselen, Germany
RECRUITINGThe radiological results of the ROM are compared to the 24 months visit before the operation.
Time frame: 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.
Time frame: Baseline and moths 24