Evaluation of Pain Following Scoliosis Surgery. | NCT03686371

Studies
Evaluation of Pain Following Scoliosis Surgery.

NCT03686371

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Apr 13, 2023Actual

Enrollment

51Actual

Phase

Not provided

Conditions

Idiopathic Scoliosis

Interventions

posterior surgery for spinal arthrodesis

Countries

France

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2018Actual

Primary Completion Date

Oct 23, 2018Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Sep 10, 2018

First Submission Date that Met QC Criteria

Sep 25, 2018

First Posted Date

Sep 26, 2018Actual

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

Apr 11, 2023

Last Update Posted Date

Apr 13, 2023Actual

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

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

51Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
posterior surgery for spinal arthrodesis	Procedure	posterior surgery for spinal arthrodesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analog Score for pain (EVA)	The assessment criteria used is the numerical pain scale from 0 to 10(0 = no pain, 10 = extremely painful	3 days after inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adolescent from 10 to 18 years of age
idiopathic scoliosis
posterior surgery for spinal arthrodesis
non opposition children and parents

Exclusion Criteria:

complication following surgery needing reoperation
secondary intervention
anterior surgery
non idiopathic scoliosis

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

adolescent with scoliosis surgery for idiopathic scoliosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne DEFONTAINE, MD	Rennes University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Rennes		Rennes		35033	France

Intervention Browse Module

MeSH Terms

ID	Term
D013123	Spinal Fusion

Ancestor Terms

ID	Term
D001174	Arthrodesis
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided