Active — Not RecruitingNot Applicable

Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages

Germany78 participantsStarted 2022-02-18

Plain-language summary

Prospective, Randomized, Single-Blind Study for the Evaluation of the Clinical Outcome and the Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages in Transforaminal Lumbar Interbody Fusion

Who can participate

Age range18 Years – 79 Years

SexALL

See this in plain English?

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

Inclusion Criteria: * Indication for one, two or three-segment lumbar interbody fusion according to Instructions for use * Written informed consent for the documentation of clinical and radiological results * Willingness and mental ability to participate at the follow-up examinations Exclusion Criteria: * Patient is not willing or able to participate at the follow-up examination * Patient age \< 18 years and \>80 years * Patient is pregnant * Previous instrumented lumbar spine surgery

What they're measuring

Clinical outcome measured with the Oswestry Disability Index

Timeframe: 1 year postoperatively

Trial details

NCT IDNCT05237908

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-05-22

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