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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Austria
Wiener Gesundheitsverbund-Klinik Penzing
RECRUITING
Vienna
Germany
DRK Klinikum Berlin
RECRUITING
Berlin
Wirbelsäulenzentrum Fulda Main, Kinzig
RECRUITING
Gelnhausen
Medizinisches Versorgungszentrum Steinburg
RECRUITING
Itzehoe
Katholisches Klinikum Koblenz - Montabaur
RECRUITING
Koblenz
Neurochirurgie am Gasteig
RECRUITING
München
Rhein-Maas Klinikum Würselen
RECRUITING
Würselen
Contact Information
Primary
Saskia Mathieu, M.Sc.
smathieu@ngmedical.de
+49687399997118
Backup
Nino Weiland, B.Sc.
nweiland@ngmedical.de
+49687399997104
Time Frame
Start Date: 2021-03-11
Estimated Completion Date: 2027-03-11
Participants
Target number of participants: 170
Treatments
Experimental: PMCF MOVE-C
PMCF MOVE®\_C is a single arm observational study with 170 patients.
Authors
Khaled Allan
Sponsors
Leads: NGMedical GmbH

This content was sourced from clinicaltrials.gov