CompletedNot Applicable

PMCF Study on the Safety and Performance of CESPACE 3D

Germany101 participantsStarted 2020-09-21

Plain-language summary

Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient is minimum 18 years old * Written informed consent for the documentation of clinical and radiological results * Patient's indication according to IFU * Patient is not pregnant Exclusion Criteria: • Patient is not willing or able to participate at the follow-up examination

What they're measuring

Change of Neck Specific Disability measured by Neck Disability Index (NDI)

Timeframe: preoperative, 12 months postoperative

Trial details

NCT IDNCT04477447

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-06-13

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