Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Discopathy, Herniated Cervical Disc, Stenoses, Spinal, Radiculopathy

Intervention / Treatment
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* Device: MOVE®-C


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PMCF MOVE-C<br>PMCF MOVE®_C is a single arm observational study with 170 patients. | Device: MOVE®-C<br>* Momo- or bisegmental implantation of MOVE®-C cervical prothesis.<br>* Other names: cervical disc prothesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herniated Disc, Cervical Spine, Discopathy, Radiculopathy