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OpenTrials
Completed

NCT Number: NCT01895426

ArcadiusXP L Post Market Clinical Follow-Up

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sana Kliniken Sommerfeld, Kremmen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. ODI (2y) - ODI(preop)

    Time frame: 2 years

    Difference between Oswestry Disability Index (ODI) at 2 years and preoperative ODI

Secondary outcomes

  1. Fusion/arthrodesis status, and further radiological documentation of operated and adjacent levels

    Time frame: 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

  2. Overall success

    Time frame: 2 years

    ODI at each timepoint

  3. Overall success

    Time frame: 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.

  4. Pain (back and leg)

    Time frame: 2 years

    Pain levels (back and leg) as measured via Visual Analogue scale (VAS) at each timepoint

  5. Adverse events

    Time frame: 2 years

  6. Patient satisfaction

    Time frame: 2 years

    "Would you have the Operation again?"

  7. Concomitant pain medication

    Time frame: 2 years

    Documentation of drug related medication

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

Clinical Follow-up of the ArcadiusXP L Stand Alone Intervertebral Body Fusion Device

Acronym: ArcadiusXPLPMS

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 10, 2013
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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