Reducing Disparities in Knee Arthroscopy for Adolescents (RED KARD)

June 16, 2026 updated by: Neeraj Patel, MD, Ann & Robert H Lurie Children's Hospital of Chicago

RED KARD: Reducing Disparities in Knee Arthroscopy for Adolescents

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Overview of study design: Teams from soccer leagues will be randomized to either participate in the intervention (aim 2) or only receive navigator information. Post-season surveys and focus groups will assess feasibility, acceptability, and appropriateness of the intervention as well as feedback for further iterative UCD. Data completeness will be tracked to assess study feasibility. Baseline and post-season surveys will compare athletes' attitudes and familiarity with surgical knee injuries and likeliness to seek care. We will collect data on injuries and clinical care, but these are secondary outcomes for this pilot study.

Inclusion and exclusion criteria: Boys and girls soccer teams from the high school divisions of soccer leagues in the Chicagoland area will be eligible for the study. Teams that are younger and older than high school-age will be excluded, since this is the highest-risk age group for surgical knee injuries. We will focus on soccer leagues because this was by far the most common sport in which patients were injured in our previous research.

Participants and recruitment: Based on the preferences of the league leadership, teams will either be approached directly by the research team or by league personnel. Many of these leagues run year-round and include 6 to 20 high school-age teams with 7- and 11-player rosters. For this pilot study, we will recruit at least eight high school-age teams (four boys and four girls teams) to include a total of at least 80 players. At the end of the season, players, coaches, and families who received the intervention will be approached to participate in focus groups to provide feedback for further iterative UCD. We will collect feedback from with 20 male players, 20 female players, 20 family members and 8 coaches (total of 10 focus groups with 6-8 participants in each).

Data collection and procedures: Teams will be randomized to either receive the intervention designed in aim 2 or only receive the patient navigator's contact information. Randomization will be performed via REDCap (Research Electronic Data Capture), allocated in a 1:1 ratio, and stratified by gender. Prior to the first game of the season, we will administer surveys on attitudes and familiarity with surgical knee injuries and likeliness to seek care to players, coaches, and families in both study arms. Players, coaches, and families randomized to the intervention arm will then participate in a brief evidence-based presentation on surgical knee injuries led by the bilingual navigator and be encouraged to contact the navigator with injury concerns throughout the season. The control group will receive the navigator's contact information without any direct engagement. Once the season begins, data will be collected on a weekly basis from coaches via REDCap with phone support and reminders by a research coordinator. This includes information about the previous week's activities (number/duration of games and practices), the number of players that participated, if any injuries occurred, and if/when medical care was sought. At the conclusion of the season, the preseason survey will be re-administered to all participants. Additionally, participants in the intervention arm will be surveyed regarding feasibility, acceptability, and appropriateness of the intervention. We will then conduct focus groups with male and female players, families, and coaches from the intervention arm to obtain qualitative feedback on intervention acceptability and appropriateness. A Spanish facilitator will be present. These sessions will be audio-recorded and last approximately 1 hour. Using explanatory sequential design to integrate mixed methods, qualitative data will provide further explanation of quantitative findings to drive further UCD. Finally, all data will be reviewed with the CAB for further iterative optimization of intervention and study design.

Outcomes: The primary outcomes of interest are intervention feasibility, appropriateness, and acceptability, as measured by three brief, reliable, and valid tools: the Feasibility of Intervention Measure, Intervention Appropriateness Measure, and Acceptability of Intervention Measure (total of 12 items using a 5-point Likert scale). Study feasibility will be measured by weekly data completeness. We will compare pre- and post-season survey responses to identify changes in attitudes and familiarity with surgical knee injuries or likeliness to seek care, and compare this data between study arms. Secondary outcomes, which will be the focus of a future, larger trial, include comparisons of frequency at which care is sought for knee injuries, time to initial medical evaluation, and time to knee surgery. Pilot data for these secondary outcomes will aid in planning a future trial.

Statistical analysis: We will use descriptive statistics to summarize data completeness and participant retention. Feasibility, appropriateness, and acceptability will be compared between groups with independent samples t-tests or Mann Whitney U-tests, depending on normality of the distributions. Methods for analyzing correlated data will be used to compare attitudes and familiarity with surgical knee injuries and likeliness to seek care. The pilot data will be used to develop effect size estimates to power a future trial. Focus group recordings will be transcribed verbatim, deidentified, and analyzed using thematic analysis. We will use a blend of inductive and deductive coding. Deductively, we will apply implementation framework domains, and inductively, we will identify codes directly from the data. Two researchers will independently review all transcripts and differences in coding will be resolved by consensus. Dedoose, a mixed methods analysis program, will be used for analysis.

Sample size and power: As this is a pilot study to determine feasibility and acceptability, we expect that 8 teams/80 players and their families as well as at least 8 coaches will provide sufficient quantitative and qualitative data.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Contact:
        • Principal Investigator:
          • Neeraj M. Patel, MD, MPH, MBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Study Population

Hispanic adolescent athletes aged 14-18 years at the time of arthroscopic knee injury for an acute injury.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
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
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.
No Intervention: Control arm
Players, coaches, and families randomized to the control arm will only receive the navigator's contact information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Intervention Measure, Intervention Appropriateness Measure, and Acceptability of Intervention Measure
Time Frame: One soccer season
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2027

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-6880
  • K23AR084596 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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