Children's Hospital of Orange County
Orange, California, 92868, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06772662
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
10 year–18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Tubing Direction
ProcedureWe are studying the procedure of placing the Cryotherapy Tubing in two different directions: up vs down
Primary outcomes
-
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
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Kiran Athreya, MPH
CONTACT
Tiffany Lubrino, MS
CONTACT
Sponsors and collaborators
Lead sponsor
Children's Hospital of Orange County
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jan 13, 2025
- Registry last updated
- Mar 13, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.