NCT03096600

Brief Summary

Mini invasive spine surgery have become very common in the past years. Posterior arthrodesis associated to liberation have good functional results and doesn't present much complication cases. So that's why St Joseph Hospital spine surgeon have made the hypothesis that this kind of surgery can be associated to fast track surgery.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2017

Typical duration for all trials

Status
withdrawn

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

February 9, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

March 26, 2017

Last Update Submit

February 4, 2020

Conditions

Keywords

spine

Outcome Measures

Primary Outcomes (1)

  • Percentage of passage to conventional hospitalization

    week 1

Secondary Outcomes (2)

  • Assessment of percentage of patients accepting fast track rehabilitation

    day1

  • Early complication rate

    day 30

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Indications for transforaminal lumbar interbody fusion

You may qualify if:

  • patient accepting fast track réhabilitation for transforaminal lumbar interbody fusion
  • age \>18 hears

You may not qualify if:

  • Age \>75
  • ASA score \>2
  • long distance between house and hôpital
  • socially isolantes
  • pathology needed conventional hospitalisation
  • psychiatric pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Pomme JOUFROY, MD

    GHPSJ

    STUDY DIRECTOR
0

Study Design

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

Study Record Dates

First Submitted

March 26, 2017

First Posted

March 30, 2017

Study Start

February 9, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share