NCT04542577

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 208 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Degenerative Instability
• Spondylolisthesis
• Post-discectomy Syndrome
• Post-traumatic Instabilities

Timeline

• Start date: 2020-09-23
• Primary completion: 2023-01-09
• Completion: 2024-01-25
• First posted: 2020-09-09
• Last updated: 2024-12-18

Locations

2 sites across 1 country: Germany