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ArcadiusXP L Post Market Clinical Follow-Up (ArcadiusXPLPMS)

Aesculap logo

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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