Cryotherapy Tubing PlacementNCT06772662
One Up, One Down: Analyzing Patient Preference on Cryotherapy Machine Tubing Placement
A study testing Tubing Direction in people with Cryotherapy Tubing Placement, run by Children's Hospital of Orange County at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Cryotherapy Tubing Placement
- What is being tested?
- Tubing Direction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Orange County
Orange, California, 92868
Kiran Athreya, MPH, 9493064857, kiran.athreya@choc.org
About this study
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.
- Conditions
- Cryotherapy Tubing Placement
- Being tested
- Tubing Direction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubing DirectionProcedure or surgery
We are studying the procedure of placing the Cryotherapy Tubing in two different directions: up vs down
| Study group | Role | What they receive |
|---|---|---|
| Tubing up | Active comparator | Patients in this arm will have their cryotherapy machine tubing placed in the upwards position facing towards the head. Receives: Procedure: Tubing Direction |
| Tubing Down | Active comparator | Patients in this arm will have their cryotherapy machine tubing placed in the downwards position facing towards the feet. Receives: Procedure: Tubing Direction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start8 Jan 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryotherapy Tubing PlacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Orange County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Schlechter, DO, Principal investigator, Children's Hospital of Orange County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772662
- Sponsor's protocol ID
- 2410125
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Age, Gender, Group Assignment, Outcome measures (satisfaction rates, pain scores).
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Up, One Down: Analyzing Patient Preference on Cryotherapy Machine Tubing Placement
- ClinicalTrials.gov ID
- NCT06772662
- Acronym / sponsor ID
- 2410125
- Conditions
- Cryotherapy Tubing Placement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's Hospital of Orange CountyUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tubing up | Active comparator | Procedure: Tubing DirectionPatients in this arm will have their cryotherapy machine tubing placed in the upwards position facing towards the head. |
| Tubing Down | Active comparator | Procedure: Tubing DirectionPatients in this arm will have their cryotherapy machine tubing placed in the downwards position facing towards the feet. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tubing DirectionWe are studying the procedure of placing the Cryotherapy Tubing in two different directions: up vs down | Procedure or surgery | Tubing Down, Tubing up |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: Yes. Age, Gender, Group Assignment, Outcome measures (satisfaction rates, pain scores).
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Schlechter, DO principal investigator
Children's Hospital of Orange County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tubing Direction in people with Cryotherapy Tubing Placement, run by Children's Hospital of Orange County at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kiran Athreya, MPH (9493064857, kiran.athreya@choc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.