ArcadiusXP L Post Market Clinical Follow-Up
- Conditions
- Degenerative Disc Disease
- Registration Number
- NCT01895426
- Lead Sponsor
- Aesculap AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ODI (2y) - ODI(preop) 2 years Difference between Oswestry Disability Index (ODI) at 2 years and preoperative ODI
- Secondary Outcome Measures
Name Time Method Overall success 2 years * 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.Pain (back and leg) 2 years Pain levels (back and leg) as measured via Visual Analogue scale (VAS) at each timepoint
Adverse events 2 years Fusion/arthrodesis status, and further radiological documentation of operated and adjacent levels 2 years 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
Patient satisfaction 2 years "Would you have the Operation again?"
Concomitant pain medication 2 years Documentation of drug related medication
Trial Locations
- Locations (2)
Sana Kliniken Sommerfeld
🇩🇪Kremmen, Germany
St. Bonifatius Hospital Lingen
🇩🇪Lingen, Germany