Evaluation of Fast Track Rehabilitaion in Mini-invasive Lombar Arthrodesis

February 4, 2020 updated by: Groupe Hospitalier Paris Saint Joseph

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Indications for transforaminal lumbar interbody fusion

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of passage to conventional hospitalization
Time Frame: week 1
week 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of percentage of patients accepting fast track rehabilitation
Time Frame: day1
day1
Early complication rate
Time Frame: day 30
day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Study Director: Pomme JOUFROY, MD, GHPSJ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

March 26, 2017

First Submitted That Met QC Criteria

March 26, 2017

First Posted (Actual)

March 30, 2017

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MISS RAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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