Evaluation of Fast Track Rehabilitaion in Mini-invasive L... | NCT03096600

Studies
Evaluation of Fast Track Rehabilitaion in Mini-invasive Lombar Arthrodesis

NCT03096600

Sponsor

Fondation Hôpital Saint-Joseph

Status

Withdrawn

Last Update Posted

Feb 5, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Rehabilitation

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The principal investigator has left the hospital.

Expanded Access Info

Start Date

Feb 9, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Mar 26, 2017

First Submission Date that Met QC Criteria

Mar 26, 2017

First Posted Date

Mar 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2020

Last Update Posted Date

Feb 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of passage to conventional hospitalization		week 1

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Indications for transforaminal lumbar interbody fusion

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Pomme JOUFROY, MD	GHPSJ	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided