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

Not Applicable

Recruiting

• Conditions: Cryotherapy Tubing Placement

• Registration Number: NCT06772662
• Lead Sponsor: Children's Hospital of Orange County

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-08
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-13
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patients will prefer one direction of tubing placement over the other (up or down) by the end of 7 days post-op	7 days	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.

Trial Locations

Locations (1)

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States