RecruitingNot ApplicableNCT05035693

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

"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


Sponsor

NGMedical GmbH

Enrollment

170 participants

Start Date

Mar 11, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This post-market study follows patients who received the MOVE-C cervical disc prosthesis — an artificial disc replacement for the neck — to evaluate its long-term safety and effectiveness in treating neck and arm pain caused by a damaged cervical disc. You may be eligible if: - You are 18 years of age or older - You have been diagnosed with a disc problem (herniation or degeneration) in the cervical spine with nerve-related symptoms - You have had neck or arm pain/weakness and have not improved with at least 6 weeks of conservative treatment - You have not had surgery on the affected cervical levels in the past 6 weeks - You are able to give written informed consent You may NOT be eligible if: - You have significant bone density loss (T-score of -1.5 or below) if you are a male over 60 or female over 50 - You have an active infection at or near the surgical site - You have an allergy to titanium or polycarbonate-urethane - You are pregnant - You have severe cervical myelopathy or advanced degenerative changes at the surgical level - You are under judicial or official custody Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMOVE®-C

Momo- or bisegmental implantation of MOVE®-C cervical prothesis.


Locations(7)

Wiener Gesundheitsverbund-Klinik Penzing

Vienna, Austria

DRK Klinikum Berlin

Berlin, Germany

Wirbelsäulenzentrum Fulda Main, Kinzig

Gelnhausen, Germany

Medizinisches Versorgungszentrum Steinburg

Itzehoe, Germany

Katholisches Klinikum Koblenz - Montabaur

Koblenz, Germany

Neurochirurgie am Gasteig

München, Germany

Rhein-Maas Klinikum Würselen

Würselen, Germany

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NCT05035693


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