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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00022971 | Other Identifier | Deutsches Register Klinischer Studien |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PMCF MOVE-C | Experimental | PMCF MOVE®_C is a single arm observational study with 170 patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOVE®-C | Device | Momo- or bisegmental implantation of MOVE®-C cervical prothesis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline and month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and months 24 |
| Change from baseline in Short Form 36 Health Survey Questionnaire (SF-36) |
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Inclusion Criteria:
Exclusion Criteria:
Known contraindication against the use of cervical intervertebral disc prostheses in accordance with the manufacturer's instructions for use:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saskia Mathieu, M.Sc. | Contact | +49687399997118 | smathieu@ngmedical.de | |
| Nino Weiland, B.Sc. | Contact | +49687399997104 | nweiland@ngmedical.de |
| Name | Affiliation | Role |
|---|---|---|
| Olaf Süss, PD Dr. med. | DRK Kliniken Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wiener Gesundheitsverbund-Klinik Penzing | Recruiting | Vienna | 1180 | Austria |
No IPD will be available for other researchers, that will not be a study site in this clinical trial.
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D011843 | Radiculopathy |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010523 | Peripheral Nervous System Diseases |
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The clinical results of SF-36 will be compared to the 24 months visit before the operation. |
| 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. | 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. | 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. | 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. | Baseline and moths 24 |
| DRK Klinikum Berlin | Recruiting | Berlin | 14050 | Germany |
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| Wirbelsäulenzentrum Fulda Main, Kinzig | Recruiting | Gelnhausen | 63571 | Germany |
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| Medizinisches Versorgungszentrum Steinburg | Recruiting | Itzehoe | 25524 | Germany |
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| Katholisches Klinikum Koblenz - Montabaur | Recruiting | Koblenz | 56073 | Germany |
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| Neurochirurgie am Gasteig | Recruiting | München | 81669 | Germany |
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| Rhein-Maas Klinikum Würselen | Recruiting | Würselen | 52146 | Germany |
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| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |