Treatment of Displaced Medial Epicondyle Fractures In Children

NCT06454929 | Not Yet Recruiting

• 1 other identifier: Medial Epicondyle Fracture
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

Compare the outcome of the operative and non-operative treatment; for fractures of the medial epicondyle of humerus in children as regards union, alignment and complications.

Conditions

Fractures, Bone

Keywords

medial epicondyle fracture

Outcome Measures

Primary Outcomes (1)

• The disabilities of the arm, shoulder and hand (QuickDASH) score

  QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.

  baseline

Study Arms (2)

operative group

ACTIVE COMPARATOR

fixation by k-wires or screws

Procedure: operative

non operative group

ACTIVE COMPARATOR

fixation by cast immobilisation

Procedure: non-operative

Interventions

operative PROCEDURE

open reduction : fixation by k-wires or screws

operative group

non-operative PROCEDURE

close reduction : by cast Immobilization

non operative group

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients Age \< 16 years presenting with a ≥2 mm displaced non-incarcerated medial epicondyle fracture with or without concomitant elbow dislocation and normal ulnar nerve function.
• Acute fractures were defined as less than7 days between the date of injury and initiation of treatment

You may not qualify if:

• systemic bone disease
• concomitant fracture or injury of the same upper limb requiring operative intervention
• Open fractures, incarceration of the fragment inside the joint or ulnar nerve dysfunction require surgery

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Pathy R, Dodwell ER. Medial epicondyle fractures in children. Curr Opin Pediatr. 2015 Feb;27(1):58-66. doi: 10.1097/MOP.0000000000000181.

  PMID: 25564187 BACKGROUND

• Beck JJ, Bowen RE, Silva M. What's New in Pediatric Medial Epicondyle Fractures? J Pediatr Orthop. 2018 Apr;38(4):e202-e206. doi: 10.1097/BPO.0000000000000902.

  PMID: 27861213 BACKGROUND

• Axibal DP, Carry P, Skelton A, Mayer SW. No Difference in Return to Sport and Other Outcomes Between Operative and Nonoperative Treatment of Medial Epicondyle Fractures in Pediatric Upper-Extremity Athletes. Clin J Sport Med. 2020 Nov;30(6):e214-e218. doi: 10.1097/JSM.0000000000000666.

  PMID: 30277893 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

ahmed ezzat M eltaweel, Physician

CONTACT

01068950894; ahmed.15235479@med.aun.edu.eg

mohamed K hassan, prof

CONTACT

01015636726; Mohamedkhaled@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: no masking
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: operative by k-wires or screws or non-operative by cast immobilisation treatment (using randomization tables/software

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 12, 2024
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 29, 2024

Record last verified: 2024-07