Recruiting

Observational Study

Sponsor:

Children's Hospital of Orange County

Code:

NCT06772662

Conditions

Cryotherapy Tubing Placement

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

Tubing Direction

Study Details

Brief summary:

The purpose of this research study is to better understand patient preference and their satisfaction rates with cryotherapy machines based on the direction of the tubing. This study will evaluate both satisfaction and pain of patients who use the cryotherapy machines in the two groups: tubing facing towards the head, and the other with tubing facing toward the feet.

Conditions

Cryotherapy Tubing Placement

Study ID

NCT06772662

Start date

Jan 8, 2025

Status verified date

Jan, 2025

Completion date

Jan 1, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients scheduled for an arthroscopic ACL reconstruction (CPT 29888) or MPFL reconstruction/augmentation with internal brace (CPT 27422 or 27429)
  • Ages 10-18 years old at the time of surgery
  • Patients who have access to a cryotherapy unit at the time of surgery

Exclusion Criteria:

  • No ACL reconstruction (CPT 29888) nor MPFL reconstruction/augmentation with internal brace (CPT 27422 or 27429) performed during knee arthroscopy (i.e., isolated meniscus repair, synovectomy/debridement, etc.)
  • Patients do not have access to a cryotherapy unit
  • Patients less than 10 or older than 18 at the time of surgery

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Tubing up

Patients in this arm will have their cryotherapy machine tubing placed in the upwards position facing towards the head.

active comparator: Tubing Down

Patients in this arm will have their cryotherapy machine tubing placed in the downwards position facing towards the feet.

Interventions

Tubing Direction

We are studying the procedure of placing the Cryotherapy Tubing in two different directions: up vs down

Primary outcome measure

  • Patients will prefer one direction of tubing placement over the other (up or down) by the end of 7 days post-op [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Kiran Athreya, MPH

9493064857kiran.athreya@choc.org

Tiffany Lubrino, MS

7143657987tiffany.lubrino@choc.org

Locations

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Contacts

Kiran Athreya, MPH

9493064857kiran.athreya@choc.org

More Information

Sponsor

Children's Hospital of Orange County

Last update posted

Mar 13, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Orange County on 2025-03-13.