Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNGMedical GmbH
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
MOVE®-C
DeviceMomo- or bisegmental implantation of MOVE®-C cervical prothesis.
Treatment groups
170 Participants
are divided into 1 treatment groupGroup A: PMCF MOVE-CExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 242
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 24Secondary outcomes
1
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 242
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 243
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 244
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 24Sponsors and contacts
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Source ClinicalTrials.gov