Status:
COMPLETED
ArcadiusXP L Post Market Clinical Follow-Up
Lead Sponsor:
Aesculap AG
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-60 years
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 pa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01895426
Start Date
April 1 2013
End Date
February 1 2017
Last Update
March 22 2017
Active Locations (2)
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1
Sana Kliniken Sommerfeld
Kremmen, Germany, 16766
2
St. Bonifatius Hospital Lingen
Lingen, Germany, 49808