One Up, One Down: Analyzing Patient Preference on Cryotherapy Machine Tubing Placement

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.

Study Overview

• Status: Recruiting
• Conditions: Cryotherapy Tubing Placement
• Intervention / Treatment: Procedure: Tubing Direction

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kiran Athreya, MPH; Phone Number: 9493064857; Email: kiran.athreya@choc.org
• Study Contact Backup: Name: Tiffany Lubrino, MS; Phone Number: 7143657987; Email: tiffany.lubrino@choc.org

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • Children's Hospital of Orange County
      • Contact: Kiran Athreya, MPH; Phone Number: 9493064857; Email: kiran.athreya@choc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tubing up; Patients in this arm will have their cryotherapy machine tubing placed in the upwards position facing towards the head.	Procedure: Tubing Direction; We are studying the procedure of placing the Cryotherapy Tubing in two different directions: up vs down
Active Comparator: Tubing Down; Patients in this arm will have their cryotherapy machine tubing placed in the downwards position facing towards the feet.	Procedure: Tubing Direction; We are studying the procedure of placing the Cryotherapy Tubing in two different directions: up vs down

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients will prefer one direction of tubing placement over the other (up or down) by the end of 7 days post-op	Patients will report their opinion and preference of tubing placement based on the group they are randomized to at the end of 7 days post-op.	7 days

Collaborators and Investigators

• Sponsor: Children's Hospital of Orange County
• Investigators: Principal Investigator: John Schlechter, DO, Children's Hospital of Orange County

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2410125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Age, Gender, Group Assignment, Outcome measures (satisfaction rates, pain scores).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No