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
Qualifiers
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
Treatments tested in this trial
- MOVE®-C
Treatment groups
170 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov