NCT03509389

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2019

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

April 14, 2018

Last Update Submit

April 25, 2018

Conditions

Spinal Diseases

Outcome Measures

Primary Outcomes (1)

  • Complication rate

    Registration of intraoperative complications during surgery

    intraoperative

Secondary Outcomes (4)

  • Oswestry Disability Index

    in 5 days from surgery - 6 months follow-up

  • Length of surgery

    intraoperative

  • Subsidence rate

    in 5 days from surgery

  • Visual Analogic Score (VAS) leg and back

    in 5 days from surgery - 6 months follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients affected by a lumbar spinal disease, indicated for surgery requiring a lateral XLIF approach to the lumbar spine, eligible to perform the approach in a prone position.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

RECRUITING

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Central Study Contacts

Elena Cittera

CONTACT

+390266214057elena.cittera@grupposandonato.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2018

First Posted

April 26, 2018

Study Start

April 7, 2018

Primary Completion

April 7, 2019

Study Completion

April 7, 2019

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

IT(1)