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

Multicenter, Not Randomised, Non-interventional, Postmarket Clinical Follow-Up (PMCF) Study on the Performance / Safety of Arcadius XP L® Interbody Fusion Device

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 Overview

• Status: Withdrawn
• Conditions: Chronic Low-back Pain; Degenerative Disc Disease; Spondylolysis Lumbar; Postdiscectomy Syndrome; Posttraumatic Instability
• Intervention / Treatment: Device: ArcadiusXP L® Interbody Fusion System

• Study Type: Observational

Contacts and Locations

Study Locations

• Germany
  • Baden-Wurttemberg
    • Esslingen am Neckar, Baden-Wurttemberg, Germany, 73728
      • Schelztor-Klinik Esslingen
    • Nürtingen, Baden-Wurttemberg, Germany, 72622
      • Medius Klinik Nurtingen
    • Schorndorf, Baden-Wurttemberg, Germany, 73614
      • Rems-Murr-Klinik Schorndorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients that received an Arcadius XP L® interbody fusion device in accordance with the indications given in the instructions for use:

Description

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:

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arcadius XP L®; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome after minimum 1 year postoperatively	The Oswestry Disability Index (ODI) is designed to measure back-specific disability. The questionnaire is self-administered and has 10 items concerning pain and activities of daily living including personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. It is a self-administered questionnaire Each section is scored on a 0-5 scale, 5 is for maximum disability. The index is calculated by dividing the total score by the total possible score, which is multiplied by 100 and expressed as a percentage. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.	at follow-up approximately 1 year postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	Pain will be assessed by the patient using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain". Pain will be recorded at minimum 12 months postoperatively, if available in the preoperative clinical routine data, it will also be recorded in the study.	at follow-up approximately 1 year postoperatively
Development Quality of life (EQ-5D-5L)	"EQ-5D-5L" is a standardized 5-dimension 5-level measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. In order to analyze the quality of life of the patients, the EQ-5D-5L is used. The score is self-completed by the patient and will therefore be used in German.	at follow-up approximately 1 year postoperatively
Radiological Outcome: Bone fusion	After Interbody Fusion surgery fusion of the treated segment is aspired. Thus, the implant design shall allow on-/ingrowth to/into the material. The fusion status can be determined from radiographs (static or dynamic). Bony fusion can be characterized quantitatively by the fusion rate.	at follow-up approximately 1 year postoperatively
Rate of (Serious) adverse events	Occurrence of complications potentially associated with the implanted devices can never be fully excluded during spinal surgery. In order to monitor potential complication and to identify so far unknown complications AEs and SAEs deemed related to the investigational device are recorded.	at follow-up approximately 1 year postoperatively

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Wolfram Reithmeier, Dr., Schelztor-Klinik

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): December 12, 2025

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: lumbar spine; stand-alone cage; interbody fusion device
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: AAG-O-H-2110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No