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

Degenerative Disc Disease Clinical Trial

— ARREST  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05944081
• Other study ID #: AAG-O-H-2110
• Status: Enrolling by invitation
• Start date: March 15, 2024
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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:

Related Conditions & MeSH terms

• Chronic Low-back Pain
• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Low Back Pain
• Spondylolysis

Intervention

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.

Locations

Country	Name	City	State
Germany	Schelztor-Klinik Esslingen	Esslingen	Baden-Württemberg
Germany	Medius Klinik Nürtingen	Nürtingen	Baden-Württemberg
Germany	Rems-Murr-Klinik Schorndorf	Schorndorf	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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