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The Prone XLIF. A Pilot Study

I

Istituto Ortopedico Galeazzi

Status

Unknown

Conditions

Spinal Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT03509389
TheProneXLIF v.1-11/1/18

Details and patient eligibility

About

Observational prospective study to evaluate the feasibility, effectiveness and the rate of complications of the XLIF (Extreme Lateral Interbody Fusion) performed in prone position to treat spinal diseases of the lumbar region.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18
  • Patients suffering from lumbar spinal disease that requires a circumferential fusion
  • Patients suitable to undergo spinal fusion with an XLIF technique (according to the label indication/contraindications)
  • Patients who are willing and able to provide written informed consent to surgery and study

Exclusion criteria

  • a congenital or post-traumatic vertebral abnormality at the target level
  • patients with a previous abdominal retroperitoneal surgery
  • patients that refuses/not suitable to undergo a XLIF surgery in prone position
  • subjects that are unable to provide a written informed consent to surgery and study
  • subjects that are unable to will or intend
  • pregnant women (declared before surgery)

Trial contacts and locations

1

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Central trial contact

Elena Cittera

Data sourced from clinicaltrials.gov

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