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NCT Number: NCT06503718

Management of Closed Diaphyseal Displaced Leg Fractures in Children and Adolescents

Most displaced tibial shaft fractures in pediatric patients have traditionally been treated after reduction by cast immobilization with good long-term results. Recently, there has been a growing trend towards surgical intervention by osteosynthesis from the outset. This study aims to describe the results of orthopedic treatment and osteosynthesis from the outset.

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Key information

Conditions

Tibial Fractures Fractures, Bone Fractures, Closed Leg Injuries Wounds and Injuries

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Chirurgie Pédiatrique - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Grah Franck LOHOUROU, MD

SUB_INVESTIGATOR

Philippe GICQUEL, MD, PhD

CONTACT

[email protected]

33 3 88 12 82 65

Philippe GICQUEL, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Minor subject (under 18 years old)
Subject treated at the HUS, between June 1, 2004 and April 31, 2024, for a fracture of the displaced diaphysis of the tibia treated orthopedically or by osteosynthesis reviewed after more than 6 months
Absence of written opposition in the medical file of the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.

Exclusion criteria

Presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.
Non-displaced and/or displaced fracture not located at the level of the tibial diaphysis
Open fracture
Incomplete or unusable file

Treatment and study plan

Primary outcomes

Evaluation of the result of orthopedic treatment and osteosynthesis from the outset

Time frame: Up to 6 months
Use of the functional score for this assessment :

Scores :
- 95-100 : Excellent
- 75-94 : Good
- 51-74 : Fair
- 0-50 : Poor

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe GICQUEL, MD

CONTACT

[email protected]

33 3 88 12 82 65

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Management of Closed Diaphyseal Displaced Leg Fractures in Children and Adolescents: Should Osteosynthesis Be Favored From the Start?

Acronym: FFD

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jul 16, 2024
Registry last updated: Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting