NCT03686371

Brief Summary

The main objective of this study was to evaluate acute pain following scoliosis surgery in adolescent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

January 2, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

September 10, 2018

Last Update Submit

April 11, 2023

Conditions

Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

posterior surgery for spinal arthrodesisPROCEDURE

posterior surgery for spinal arthrodesis

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

adolescent with scoliosis surgery for idiopathic scoliosis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Interventions

Spinal Fusion

Intervention Hierarchy (Ancestors)

ArthrodesisOrthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Anne DEFONTAINE, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 26, 2018

Study Start

January 2, 2018

Primary Completion

October 23, 2018

Study Completion

June 30, 2019

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations

FR(1)