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

Spondylolisthesis Clinical Trial

Official title:
Multicenter PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D - A Prospective Study on Total Indications

Clinical Trial Summary

Prospective, pure data collection of all PROSPACE 3D, PROSPACE 3D Oblique, TSPACE 3D patients in selected centers (not interventional, multicenter

Clinical Trial Description

The study collects a data set for each patient receiving a PROSPACE 3D, PROSPACE 3D Oblique, or TSPACE 3D implant. It is intended to collect data preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively containing - Basic medical history - Type of surgical procedure - Treated segments - Implant characteristics (including additional implants for anterior/posterior stabilization) - Scores: ODI, Pain (VAS), EQ-5D - Patient satisfaction ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04542577
Study type Observational
Source Aesculap AG
Contact
Status Active, not recruiting
Phase
Start date September 23, 2020
Completion date February 2024
View Details
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