Status:
ACTIVE_NOT_RECRUITING
Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages
Lead Sponsor:
Aesculap AG
Conditions:
Disk Herniated Lumbar
Disc Disease Degenerative
Eligibility:
All Genders
18-79 years
Brief 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 ...
Detailed Description
This clinical study is a regulatory Post Market Clinical Follow-Up (PMCF) measure and is aiming to collect clinical data on the performance and safety of the TSPACE® 3D implants. It is designed as a p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05237908
Start Date
February 18 2022
End Date
August 1 2028
Last Update
June 26 2025
Active Locations (1)
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1
BG Unfallklinik Frankfurt am Main
Frankfurt am Main, Hesse, Germany, 60389