Management of Closed Diaphyseal Displaced Leg Fractures in Children and Adolescents

NCT06503718 | Recruiting

• 1 other identifier: 9244
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tibial Fractures

Keywords

Tibial Fractures; Osteosynthesis, Fracture; Closed Fracture

Outcome Measures

Primary Outcomes (1)

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

  Use of the functional score for this assessment : Scores : * 95-100 : Excellent * 75-94 : Good * 51-74 : Fair * 0-50 : Poor

  Up to 6 months

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Minor subject (under 18 years old) 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Chirurgie Pédiatrique - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Tibial Fractures; Fractures, Bone; Fractures, Closed

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Central Study Contacts

Philippe GICQUEL, MD

CONTACT

33 3 88 12 82 65; Philippe.Gicquel@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: April 3, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

FR (1)