Degenerative Disc DiseaseArcadiusXPLPMSNCT01895426
ArcadiusXP L Post Market Clinical Follow-Up
An observational study of Degenerative Disc Disease, run by Aesculap AG at 2 sites in Germany.
Trial summary
The purpose of this study is to collect clinical and radiological mid-term (2 years) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 32 patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Degenerative Disc Disease
- How many people
- 32 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2013to Feb 2017
- 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: adult patients
Who may be able to join
- all indications as given by the instructions for use
- Patients with persisting lumbosacral and pseudo-radicular pain scheduled for monosegmental lumbar interbody fusion from L4 to S1
- Age 18 - 60
- at least 6 months of unsuccessful treatment including conservative measures
- Non-sequestrated and subligamentous prolapse
Who cannot join
- all contraindications, which are listed in the instructions for use.
- existing pregnancy, planned or occurring during study period
- patients with a higher degree of segmental degeneration in other than the segment to be operated
- body- mass-index (BMI) > 30
- Systemic or local infection
- Increased risk of osteoporosis according to assessment by the SCORE evaluation
Show all 12Show fewer
- Bone metabolism disorders
- Chemotherapy or radiotherapy (ongoing or planned)
- Participation in another clinical trial
- Scheduled for spinal litigation
- Other serious conditions that hinder the participation in the study
- Nanogel® filling of the cage, prior to implantation was not done
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Sana Kliniken Sommerfeld
Kremmen, 16766
St. Bonifatius Hospital Lingen
Lingen, 49808
About this study
Official title: Clinical Follow-up of the ArcadiusXP L Stand Alone Intervertebral Body Fusion Device
The purpose of this study is to collect clinical and radiological mid-term (2 years) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 32 patients.
- Conditions
- Degenerative Disc Disease
- Medical subject headings
- Intervertebral Disc Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
ODI (2y) - ODI(preop)
Difference between Oswestry Disability Index (ODI) at 2 years and preoperative ODI
Measured: 2 years
Secondary outcomes (7)
Fusion/arthrodesis status, and further radiological documentation of operated and adjacent levels
Angle difference in flexion and extension radiographs at each timepoint; analysis of AP and ML x-rays regarding changes in bone density (identification of bone bridges): CT/MRT are considered when available; consideration of pot. radiolucencies around the
Measured: 2 years
Overall success
ODI at each timepoint
Measured: 2 years
Overall success
- Improvement of at least 15 points in the Oswestry Disability Index score compared to the baseline score;
- No device failures requiring revision, reoperation, or removal;
- Absence of major complications, defined as major vessel injury or major neurological deterioration (e.g., nerve root injury);
- Maintenance or improvement in neurological status vs. baseline, with no permanent neurological deficits compared to baseline status.
Measured: 2 years
Pain (back and leg)
Pain levels (back and leg) as measured via Visual Analogue scale (VAS) at each timepoint
Measured: 2 years
Adverse events
Measured: 2 years
Patient satisfaction
"Would you have the Operation again?"
Measured: 2 years
Concomitant pain medication
Documentation of drug related medication
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Douglas Klassen, MD (PY), Principal investigator, St. Bonifatius Hospital Lingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895426
- Sponsor's protocol ID
- AAG-O-H-1227
- Acronym
- ArcadiusXPLPMS
- Status last verified
- Mar 2017
- First submitted
- 5 Jul 2013
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Follow-up of the ArcadiusXP L Stand Alone Intervertebral Body Fusion Device
- ClinicalTrials.gov ID
- NCT01895426
- Acronym / sponsor ID
- ArcadiusXPLPMS / AAG-O-H-1227
- Conditions
- Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2013 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 10 Jul 2013 (estimated)
- 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 (2 years) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 32 patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- adult patients
Key inclusion criteria (5 listed)
- all indications as given by the instructions for use
- Patients with persisting lumbosacral and pseudo-radicular pain scheduled for monosegmental lumbar interbody fusion from L4 to S1
- Age 18 - 60
- at least 6 months of unsuccessful treatment including conservative measures
- Non-sequestrated and subligamentous prolapse
Key exclusion criteria (12 listed)
- all contraindications, which are listed in the instructions for use.
- existing pregnancy, planned or occurring during study period
- patients with a higher degree of segmental degeneration in other than the segment to be operated
- body- mass-index (BMI) > 30
- Systemic or local infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ODI (2y) - ODI(preop)
Time frame: 2 years
Difference between Oswestry Disability Index (ODI) at 2 years and preoperative ODI
7 secondary outcomes
Fusion/arthrodesis status, and further radiological documentation of operated and adjacent levels
Time frame: 2 years
Overall success
Time frame: 2 years
Overall success
Time frame: 2 years
Pain (back and leg)
Time frame: 2 years
Adverse events
Time frame: 2 years
Patient satisfaction
Time frame: 2 years
Concomitant pain medication
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
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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.
Peter Douglas Klassen, MD (PY) principal investigator
St. Bonifatius Hospital Lingen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by Aesculap AG at 2 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ODI (2y) - ODI(preop) (time frame: 2 years). 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 22 Mar 2017.