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

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

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

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

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