Chronic Low-back PainARRESTNCT05944081
Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device
An observational study of Chronic Low-back Pain and Degenerative Disc Disease, run by Aesculap AG at 3 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low-back Pain, Degenerative Disc Disease, Spondylolysis Lumbar
- What is being tested?
- ArcadiusXP L® Interbody Fusion System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 3 sitesGermany
- Study dates
- 15 Mar 2024to 12 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: All patients that received an Arcadius XP L® interbody fusion device in accordance with the indications given in the instructions for use:
Who may be able to join
- 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
Who cannot join
- 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:
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Schelztor-Klinik Esslingen
Esslingen am Neckar, Baden-Wurttemberg, 73728
Medius Klinik Nürtingen
Nürtingen, Baden-Wurttemberg, 72622
Rems-Murr-Klinik Schorndorf
Schorndorf, Baden-Wurttemberg, 73614
About this study
Official title: 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.
- Conditions
- Chronic Low-back Pain, Degenerative Disc Disease, Spondylolysis Lumbar, Postdiscectomy Syndrome, Posttraumatic Instability
- Being tested
- ArcadiusXP L® Interbody Fusion System
- Keywords
- stand-alone cage, lumbar spine, interbody fusion device
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArcadiusXP L® Interbody Fusion SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: ArcadiusXP L® Interbody Fusion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at follow-up approximately 1 year postoperatively
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at follow-up approximately 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start15 Mar 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Why it stopped: Limited patient willingness and clinic capacity hindered follow-up data collection for the registry study, as appointments required extra resources beyond routine care.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfram Reithmeier, Dr., Principal investigator, Schelztor-Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944081
- Sponsor's protocol ID
- AAG-O-H-2110
- Acronym
- ARREST
- Status last verified
- Aug 2025
- First submitted
- 3 Jul 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Not Randomised, Non-interventional, Postmarket Clinical Follow-Up (PMCF) Study on the Performance / Safety of Arcadius XP L® Interbody Fusion Device
- ClinicalTrials.gov ID
- NCT05944081
- Acronym / sponsor ID
- ARREST / AAG-O-H-2110
- Conditions
- Chronic Low-back Pain, Degenerative Disc Disease, Spondylolysis Lumbar, Postdiscectomy Syndrome, Posttraumatic Instability
- Keywords
- stand-alone cage, lumbar spine, interbody fusion device
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Limited patient willingness and clinic capacity hindered follow-up data collection for the registry study, as appointments required extra resources beyond routine care.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arcadius XP L® | – | Device: ArcadiusXP L® Interbody Fusion Systemall 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients that received an Arcadius XP L® interbody fusion device in accordance with the indications given in the instructions for use:
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArcadiusXP L® Interbody Fusion SystemThe 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. | Device | Arcadius XP L® |
Primary outcome
Functional outcome after minimum 1 year postoperatively
Time frame: 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.
4 secondary outcomes
Pain assessment
Time frame: at follow-up approximately 1 year postoperatively
Development Quality of life (EQ-5D-5L)
Time frame: at follow-up approximately 1 year postoperatively
Radiological Outcome: Bone fusion
Time frame: at follow-up approximately 1 year postoperatively
Rate of (Serious) adverse events
Time frame: at follow-up approximately 1 year postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfram Reithmeier, Dr. principal investigator
Schelztor-Klinik
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain and Degenerative Disc Disease, run by Aesculap AG at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome after minimum 1 year postoperatively (time frame: at follow-up approximately 1 year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.