ArcadiusXP L Post Market Clinical Follow-Up (ArcadiusXPLPMS)

Aesculap

Status: Completed

Conditions: Degenerative Disc Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01895426

AAG-O-H-1227

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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