NCT07580625

Brief Summary

Hundreds of thousands of youth athletes require surgery for knee injuries annually. The incidence of operative knee injuries has skyrocketed, but surgery can be delayed due to late recognition and barriers, such as insurance, language, and difficulty navigating the healthcare system. Delays may have lifelong effects, including arthritis, persistent instability, poor patient reported outcomes, and reoperation. There is little patient-centered research on barriers to orthopaedic care, and none on interventions to reduce disparities in pediatric sports medicine. This study will focus on Hispanic children, a growing population nationally and 38% of the Chicago's children, who are at increased risk of delayed knee surgery and its sequelae compared to white, non-Hispanic patients. The overall objectives are to identify barriers to timely knee surgery in Hispanic athletes and develop an intervention to implement evidence on expedient treatment. The aim of this study is to evaluate feasibility, acceptability, and appropriateness of a culturally-tailored intervention in a pilot study of Hispanic youth soccer leagues. The proposed study will drive creation of a future community trial of a culturally-tailored intervention.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started Oct 2027

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

April 28, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 1, 2027

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

1.7 years

First QC Date

April 28, 2026

Last Update Submit

June 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Intervention Measure, Intervention Appropriateness Measure, and Acceptability of Intervention Measure

    The primary outcomes of interest are intervention feasibility, appropriateness, and acceptability, as measured by these three brief, reliable, and valid tools. They include a total of 12 items using a 5-point Likert scale).

    One soccer season

Study Arms (2)

Intervention arm

EXPERIMENTAL

Players, coaches, and families randomized to the intervention arm will participate in a brief evidence-based presentation on surgical knee injuries led by a bilingual navigator and be encouraged to contact the navigator with injury concerns throughout the season.

Behavioral: Educational program and patient navigator

Control arm

NO INTERVENTION

Players, coaches, and families randomized to the control arm will only receive the navigator's contact information.

Interventions

Players, coaches, and families randomized to the intervention arm will participate in a brief evidence-based presentation on surgical knee injuries led by a bilingual navigator and be encouraged to contact the navigator with injury concerns throughout the season.

Intervention arm

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Predominantly Hispanic soccer team
  • Players between 14-18 years of age

You may not qualify if:

  • Players younger than 14 or older than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Knee InjuriesAnterior Cruciate Ligament Injuries

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending surgeon

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 12, 2026

Study Start (Estimated)

October 1, 2027

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

June 18, 2026

Record last verified: 2026-06

Locations