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

NCT05944081 | Withdrawn

• 1 other identifier: AAG-O-H-2110
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

stand-alone cage; lumbar spine; interbody fusion device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain assessment

  at follow-up approximately 1 year postoperatively

• Development Quality of life (EQ-5D-5L)

  at follow-up approximately 1 year postoperatively

• Radiological Outcome: Bone fusion

  at follow-up approximately 1 year postoperatively

• Rate of (Serious) adverse events

  at follow-up approximately 1 year postoperatively

Study Arms (1)

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

Interventions

ArcadiusXP L® Interbody Fusion System DEVICE

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.

Arcadius XP L®

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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:

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (3)

Schelztor-Klinik Esslingen

Esslingen am Neckar, Baden-Wurttemberg, 73728, Germany

Location

Medius Klinik Nürtingen

Nürtingen, Baden-Wurttemberg, 72622, Germany

Location

Rems-Murr-Klinik Schorndorf

Schorndorf, Baden-Wurttemberg, 73614, Germany

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Wolfram Reithmeier, Dr.

  Schelztor-Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 13, 2023
• Study Start: March 15, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 12, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)