CompletedNot Applicable

PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D

Germany208 participantsStarted 2020-09-23

Plain-language summary

Prospective, pure data collection of all PROSPACE 3D, PROSPACE 3D Oblique, TSPACE 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: * 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: \- Patient is not willing or able to participate at the follow-up examination

What they're measuring

Change of Spinal Disability measured by Oswestry Disability Index (ODI)

Timeframe: preoperatively, at 3 months postoperatively and at 12 months postoperatively

Trial details

NCT IDNCT04542577

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-01-09

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