Cast or Operation for Medial Epicondyle Fracture Treatment in Children

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
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 superiority trial of medial epicondyle fracture treatments comparing functional outcomes between children treated with operative reduction and fixation or non-operative immobilization.

Key Dates

Start date
Oct 28, 2022
Status verified
Aug 2024
Primary completion
Oct 31, 2027
Completion
Aug 31, 2028

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]
Candace Young
[email protected]
Joseph Janicki, MD (PRINCIPAL_INVESTIGATOR)

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

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