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

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

• Registration Number: NCT05944081
• Lead Sponsor: Aesculap AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-13
• Study Start: 2024-03-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arcadius XP L®	ArcadiusXP L® Interbody Fusion System	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

Primary Outcome Measures

Name	Time	Method
Functional outcome after minimum 1 year postoperatively	at follow-up approximately 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.

Secondary Outcome Measures

Name	Time	Method
Radiological Outcome: Bone fusion	at follow-up approximately 1 year postoperatively	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.
Rate of (Serious) adverse events	at follow-up approximately 1 year postoperatively	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.
Pain assessment	at follow-up approximately 1 year postoperatively	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.
Development Quality of life (EQ-5D-5L)	at follow-up approximately 1 year postoperatively	"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.

Trial Locations

Locations (3)

Medius Klinik Nürtingen; 🇩🇪 Nürtingen, Baden-Württemberg, Germany

Schelztor-Klinik Esslingen; 🇩🇪 Esslingen, Baden-Württemberg, Germany

Rems-Murr-Klinik Schorndorf; 🇩🇪 Schorndorf, Baden-Württemberg, Germany