Health Trials

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 group

Locations

7
Austria
Wiener Gesundheitsverbund-Klinik Penzing1180, Vienna Austria
Germany
DRK Klinikum Berlin14050, Berlin Germany
Wirbelsäulenzentrum Fulda Main, Kinzig63571, Gelnhausen Germany
Medizinisches Versorgungszentrum Steinburg25524, Itzehoe Germany

Sponsors and collaborators

NGMedical GmbH

Lead sponsor

Source ClinicalTrials.gov