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

C

Children's Health of Orange County

Status

Enrolling

Conditions

Cryotherapy Tubing Placement

Treatments

Procedure: Tubing Direction

Study type

Interventional

Funder types

Other

Identifiers

NCT06772662
2410125

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Tubing up
Active Comparator group
Description:
Patients in this arm will have their cryotherapy machine tubing placed in the upwards position facing towards the head.
Treatment:
Procedure: Tubing Direction
Tubing Down
Active Comparator group
Description:
Patients in this arm will have their cryotherapy machine tubing placed in the downwards position facing towards the feet.
Treatment:
Procedure: Tubing Direction

Trial contacts and locations

1

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Central trial contact

Kiran Athreya, MPH; Tiffany Lubrino, MS

Data sourced from clinicaltrials.gov

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