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

NCT05944081 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-09-05

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Low-back Pain
  • Degenerative Disc Disease
  • Spondylolysis Lumbar
  • Postdiscectomy Syndrome
  • Posttraumatic Instability

Interventions

DEVICE

ArcadiusXP L® Interbody Fusion System

The ArcadiusXP L® Interbody Fusion System is a stand-alone device intended to be used with four bone screws if no supplement fixation is used to stabilize the lumbar spine through an anterior approach. Levels of anterior lumbar interbody fusion for the indications listed in the instructions for use are from L2-S1.

Sponsors & Collaborators

  • Aesculap AG

    lead INDUSTRY

Principal Investigators

  • Wolfram Reithmeier, Dr. · Schelztor-Klinik

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2025-08-31
Completion
2025-12-12

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05944081 on ClinicalTrials.gov