The Prone XLIF. A Pilot Study

The Prone XLIF. An Observational Pilot Study Based on Prospective Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03509389

Enrollment

Registered

2018-04-26

Start date

2018-04-07

Completion date

2019-04-07

Last updated

2018-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Diseases

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
Complication rate	intraoperative	Registration of intraoperative complications during surgery

Secondary

Measure	Time frame	Description
Oswestry Disability Index	in 5 days from surgery - 6 months follow-up	Evaluation of clinical outcomes using Oswestry Disability Index (ODI) questionnaire. It is a scaled questionnaire from 0 to 100 in which the higher the value, the worst the outcome.
Length of surgery	intraoperative	Evaluation of length of surgery
Subsidence rate	in 5 days from surgery	Evaluation of subsidence rate at postoperative x-ray
Visual Analogic Score (VAS) leg and back	in 5 days from surgery - 6 months follow-up	Evaluation of clinical outcomes using the VAS score, going from 0 to 10, where 0 means no pain and 10 the worst pain possible.

Countries

Italy

Contacts

Primary ContactElena Cittera

elena.cittera@grupposandonato.it+390266214057

Outcome results