ArcadiusXP L Post Market Clinical Follow-Up
ArcadiusXPLPMS
Clinical Follow-up of the ArcadiusXP L Stand Alone Intervertebral Body Fusion Device
1 other identifier
observational
32
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2013
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 5, 2013
CompletedFirst Posted
Study publicly available on registry
July 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMarch 22, 2017
March 1, 2017
3.8 years
July 5, 2013
March 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
ODI (2y) - ODI(preop)
Difference between Oswestry Disability Index (ODI) at 2 years and preoperative ODI
2 years
Secondary Outcomes (7)
Fusion/arthrodesis status, and further radiological documentation of operated and adjacent levels
2 years
Overall success
2 years
Overall success
2 years
Pain (back and leg)
2 years
Adverse events
2 years
- +2 more secondary outcomes
Eligibility Criteria
adult patients
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aesculap AGlead
Study Sites (2)
Sana Kliniken Sommerfeld
Kremmen, 16766, Germany
St. Bonifatius Hospital Lingen
Lingen, 49808, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Douglas Klassen, MD (PY)
St. Bonifatius Hospital Lingen
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2013
First Posted
July 10, 2013
Study Start
April 1, 2013
Primary Completion
January 1, 2017
Study Completion
February 1, 2017
Last Updated
March 22, 2017
Record last verified: 2017-03