NCT05131672

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Oct 2022Aug 2028

First Submitted

Initial submission to the registry

October 4, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

October 28, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

5 years

First QC Date

October 4, 2021

Last Update Submit

August 28, 2024

Conditions

Fracture Elbow

Outcome Measures

Primary Outcomes (1)

  • pediatric upper extremity function PROMIS computer adaptive test (PROMIS UE CAT)

    functional and patient reported outcomes

    1 year follow-up

Secondary Outcomes (11)

  • PROMIS UE Computerized Adaptive Test (CAT)

    6 weeks and 3, and 6 months

  • Disabilities of the Arm, Shoulder and Hand (DASH) S/PA

    6 weeks and 3, and 6 months

  • PROMIS Pain interference

    6 weeks, 3, 6, and 12 months

  • Wong-Baker Faces Pain scores

    6 weeks, 3, 6, and 12 months

  • Radiographic assessment of fracture healing

    3 months

  • +6 more secondary outcomes

Study Arms (2)

Operative reduction w/ fixation

EXPERIMENTAL

open reduction and internal fixation (ORIF)

Procedure: open reduction and internal fixation (ORIF)

Non-operative immobilization

ACTIVE COMPARATOR

immobilization in a cast without reduction

Procedure: cast immobilization

Interventions

open reduction and internal fixation (ORIF)PROCEDURE

open reduction and internal fixation with pin or screw fixation

Operative reduction w/ fixation
cast immobilizationPROCEDURE

immobilization in a cast without reduction

Non-operative immobilization

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Provision of signed and dated informed consent form by parent or legal guardian and signed assent form if participant is older than 12 years.
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 7-17 years inclusive
  • Diagnosis of medial epicondyle fracture with any amount of displacement
  • Fracture is acute (occurred within 10 days of assignment of treatment arm)
  • Ability to take oral medication and be willing to adhere to the immobilization regimen

You may not qualify if:

  • Medial epicondyle fragment that is incarcerated within joint
  • Presence of other fractures about the ipsilateral elbow
  • Presence of pathologic fracture, open fracture
  • Have metabolic or neuromuscular diagnosis
  • Patient and parents are unable to adhere to procedures or complete follow-up due to insufficient comprehension of consent form or surveys or developmental delay.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Elbow Fractures

Interventions

Open Fracture ReductionFracture Fixation, Internal

Condition Hierarchy (Ancestors)

Elbow InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Joseph Janicki, MD

    Ann and Robert H. Lurie Hospital Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie Burgess, PhD

CONTACT

312-227-6531jburgess@luriechildrens.org

Candace Young, BS

CONTACT

312-227-6427cayoung@luriechildrens.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2021

First Posted

November 23, 2021

Study Start

October 28, 2022

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

August 31, 2028

Last Updated

August 30, 2024

Record last verified: 2024-08

Locations

US(1)