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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorChildren's Hospital of Orange County

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Tubing Direction

    Procedure/Surgery

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Tubing upActive comparator 1 intervention
Group B: Tubing DownActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
7 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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