Cryotherapy EffectNCT04222933
Effect of Motorized Cryotherapy on Early Effusion, Swelling, and Pain After Anterior Cruciate Ligament Reconstruction
A study testing Motorized cryotherapy and Classical cryotherapy in people with Cryotherapy Effect, run by Hanyang University Seoul Hospital at 1 site in South Korea.
Trial summary
To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Cryotherapy Effect
- What is being tested?
- Motorized cryotherapy and Classical cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2019to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Acute ACL ruptured patient
Who cannot join
- Combined meniscal injury requiring surgery
- Combined ligament injury requiring surgery
- Combined chondral injury requiring surgery
- Previous surgery history on corresponding knee
- Allergic to cold
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Orthopaedic Surgery, Hanyang University, College of Medicine
Seoul, 133-792
About this study
Official title: Effect of Motorized Cryotherapy on Early Effusion, Swelling, and Pain After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction
Read the detailed description
To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction compared to classical ice bagging
- Conditions
- Cryotherapy Effect
- Being tested
- Motorized cryotherapy, Classical cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motorized cryotherapyDevice
application of motorized cryotherapy after ACL reconstruction
Classical cryotherapyDevice
application of an ice bag
| Study group | Role | What they receive |
|---|---|---|
| Motorized cryotherapy | Experimental | Application of motorized cryotherapy after ACL reconstruction for 6 postoperative days Receives: Device: Motorized cryotherapy |
| Classical cryotherapy | Active comparator | Application of ice bags for 6 postoperative days Receives: Device: Classical cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain after surgery
VAS pain scale (0 to 10 points, higher the worse pain)
Measured: postoperative day 4
Secondary outcomes (1)
Effusion after surgery
Effusion by thigh circumference (cm), MRI measurement (cc)
Measured: baseline, postoperative day 4, 7, 14, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start1 Apr 2019
- Primary completion1 Mar 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryotherapy EffectStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIN KYU LEE, Hanyang University Seoul Hospital
- Investigators
- JIN KYU LEE, PHD, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222933
- Sponsor's protocol ID
- Hanyang university cryo
- Status last verified
- Jun 2021
- First submitted
- 5 Jan 2020
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motorized Cryotherapy on Early Effusion, Swelling, and Pain After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04222933
- Acronym / sponsor ID
- Hanyang university cryo
- Conditions
- Cryotherapy Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 10 Jan 2020 (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.
To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction
Detailed description
To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction compared to classical ice bagging
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motorized cryotherapy | Experimental | Device: Motorized cryotherapyApplication of motorized cryotherapy after ACL reconstruction for 6 postoperative days |
| Classical cryotherapy | Active comparator | Device: Classical cryotherapyApplication of ice bags for 6 postoperative days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Acute ACL ruptured patient
Key exclusion criteria (5 listed)
- Combined meniscal injury requiring surgery
- Combined ligament injury requiring surgery
- Combined chondral injury requiring surgery
- Previous surgery history on corresponding knee
- Allergic to cold
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 |
|---|---|---|
| Motorized cryotherapyapplication of motorized cryotherapy after ACL reconstruction | Device | Motorized cryotherapy |
| Classical cryotherapyapplication of an ice bag | Device | Classical cryotherapy |
Primary outcome
Pain after surgery
Time frame: postoperative day 4
VAS pain scale (0 to 10 points, higher the worse pain)
1 secondary outcome
Effusion after surgery
Time frame: baseline, postoperative day 4, 7, 14, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
JIN KYU LEE, PHD principal investigator
Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motorized cryotherapy and Classical cryotherapy in people with Cryotherapy Effect, run by Hanyang University Seoul Hospital at 1 site in South Korea.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 22 Jun 2021. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain after surgery (time frame: postoperative day 4). 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 22 Jun 2021.