The Prone XLIF. A Pilot Study

NCT ID: NCT03509389

Last Updated: 2018-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-07

Study Completion Date

2019-04-07

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elena Cittera

Role: CONTACT

+390266214057

Facility Contacts

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Elena Cittera

Role: primary

+390266214057

Other Identifiers

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TheProneXLIF v.1-11/1/18

Identifier Type: -

Identifier Source: org_study_id

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