Cast or Operation for Medial Epicondyle Fracture Treatment in Children

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Joseph Janicki
Study ID
NCT05131672
Status
Recruiting
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Conditions

  • Fracture Elbow

Eligibility Criteria

Sex
ALL
Age
7 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • open reduction and internal fixation (ORIF) — PROCEDURE
    open reduction and internal fixation with pin or screw fixation
  • cast immobilization — PROCEDURE
    immobilization in a cast without reduction

Study Details

This protocol describes a multicenter, prospective randomized and patient preference cohort superiority trial of medial epicondyle fracture treatments comparing functional outcomes between children treated with operative reduction and fixation or non-operative immobilization.

Key Dates

First listed
Nov 23, 2021
Start date
Oct 28, 2022
Status verified
Jun 2026
Primary completion
Dec 31, 2030
Completion
Jul 31, 2031

Study Design

Enrollment
334 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Operative reduction w/ fixation
    open reduction and internal fixation (ORIF)
  • Active Comparator: Non-operative immobilization
    immobilization in a cast without reduction

Primary Outcome Measure

pediatric upper extremity function PROMIS computer adaptive test (PROMIS UE CAT) [ Time Frame: 1 year follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lurie Children's HospitalChicagoIllinois60611
Jamie Burgess, PhD
[email protected]
Michelle Adzido
[email protected]
Joseph Janicki, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Lurie Children's Hospital· Chicago, IL

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