Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device (ARREST)

Aesculap

Status: Withdrawn

Conditions: Posttraumatic Instability; Postdiscectomy Syndrome; Degenerative Disc Disease; Chronic Low-back Pain; Spondylolysis Lumbar

Treatments: Device: ArcadiusXP L® Interbody Fusion System

Study type: Observational

Funder types: Industry

Identifiers

NCT05944081

AAG-O-H-2110

Details and patient eligibility

About

The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients who received a Arcadius XP L® interbody fusion device between 2016 until approx. January 2021 (minimum Follow-up is one year) in the study center
• all indications as given by the instructions for use: degenerative disc disease (DDD), Instability, Spondylolisthesis up to grade 1, Post-discectomy syndrome, Post-traumatic instability
• Written informed consent for the documentation of clinical and radiological results

Exclusion criteria

• Patient is not willing or able to participate at the follow-up examination
• Patients living outside a radius of 100 km around the study center
• all contraindications as given by the instructions for use:

Trial design

0 participants in 1 patient group

Arcadius XP L®

Description:

all patients who received a Arcadius XP L® interbody fusion device between 2016 until approx. January 2021 (minimum Follow-up is one year) in the study center

Treatment:

Device: ArcadiusXP L® Interbody Fusion System