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

Aesculap

Status: Completed

Conditions: Post-discectomy Syndrome; Spondylolisthesis; Post-traumatic Instabilities; Degenerative Instability

Study type: Observational

Funder types: Industry

Identifiers

NCT04542577

AAG-O-H-2003

Details and patient eligibility

About

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

Full 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

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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