Improved Rehabilitation After Spinal Surgery in Adolescents

NCT ID: NCT04183049

Last Updated: 2021-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-18

Study Completion Date

2021-08-01

Brief Summary

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Impact of the OFA technique on postoperative recovery from adolescent spine surgery and the incidence of chronic postoperative pain.

Detailed Description

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RACAROFA is an observational, prospective study based on the hypothesis that the OFA technique effectively improves the long-term postoperative rehabilitation of adolescents and reduces the incidence of CPSP. A prospective French multicentre study on this topic is currently not feasible, as other multicentre studies (pain monitoring by the ANI, blood saving strategy) would interfere with potential recruitment.

Conditions

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Pain, Postoperative Pain Scoliosis Spinal Fusion

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patent with idiopathic or secondary surgical scoliosis
* Management by the paediatric anaesthesia team at the Mother and Child - Hospital of the University Hospital of Nantes
* Non-opposition to inclusion in the study collected orally from the patient and parents
* Satisfying oral and written comprehension of the French language, without interpreter
* Ability to participate in a telephone interview

Exclusion Criteria

* Patient that does not understand French correctly
* Patient unable to express himself/herself correctly in French
* Patient with a non-scoliotic surgical spinal pathology
* Refusal to participate in the study
* Absence of a record of non-opposition to participation in the study from the patient and his or her parents
* Cerebral palsy or any other condition that does not allow participation in a telephone interview without particular difficulty.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corine LEJUS, PUPH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Guy LETELLIER, PH

Role: PRINCIPAL_INVESTIGATOR

ESEAN

Locations

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Nantes University Hospital

Nantes, Loire-Atlantique, France

Site Status

Countries

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France

Other Identifiers

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RC19_0255

Identifier Type: -

Identifier Source: org_study_id

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