Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device
WithdrawnNCT05944081
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Multicenter, Not Randomised, Non-interventional, Postmarket Clinical Follow-Up (PMCF) Study on the Performance / Safety of Arcadius XP L® Interbody Fusion Device
- Conditions
- Chronic Low-back Pain
- Degenerative Disc Disease
- Spondylolysis Lumbar
- Postdiscectomy Syndrome
- Posttraumatic Instability
- Interventions
- Device: ArcadiusXP L® Interbody Fusion System
- Sponsor
- Aesculap AG
- Start date
- 2024-03-15
- Primary completion
- 2025-08-31
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- Germany
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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:
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05944081