Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages (PRINTLIF)
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About
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
Full 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 prospective, randomized, single-blind, non-interventional study in order to gain clinical data within the routine clinical application of the investigational device.
The study shall answer the question if there are detectable differences between the established titanium coated Polyether Ether Ketone (PEEK) cages of the manufacturer and the new 3D printed cages. Differences shall be observed in terms of clinical outcome, quality of life, patient satisfaction, radiological outcome and occurrence of Adverse Events / Serious Adverse Events.
Enrollment
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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
Trial design
78 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Stefan Maenz, Dr.
Data sourced from clinicaltrials.gov
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