Postoperative Swelling After TKANCT07627854
Postoperative Cryocuff vs. Conventional Icepack in TKA - What is More Effective in Reducing Pain and Swelling?
A study testing cryo cuff treatment and postoperative cooling with conventional ice pack in people with Postoperative Swelling After TKA and Postoperative Pain After Tka, run by Prof. Dr. med. Andreas Halder at 1 site in Germany.
Trial summary
Topic/Disease Pattern Postoperative pain and swelling management after knee prosthesis implantation using cryotherapy Objective To determine possible differences in postoperative swelling and pain following primary total knee arthroplasty (TKA) under cryotherapy using cuff cooling versus conventional ice pack… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Swelling After TKA, Postoperative Pain After Tka
- What is being tested?
- cryo cuff treatment and postoperative cooling with conventional ice pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- 27 May 2026to May 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form (signed by the patient and the responsible study physician)
- Primary total knee arthroplasty (TKA) Age ≥ 18 years
- Willingness to document the NRS score and subjective feeling of tightness after 4 weeks
Who cannot join
- Obesity with BMI ≥ 40
- Lymphedema
- Lymphatic drainage therapy
- Revision total knee arthroplasty (TKA) surgeries
- Primary unicondylar knee arthroplasty
- Study physicians, relatives, employees, or other dependent persons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Sana Kliniken Sommerfeld
Kremmen, Brandenburg, 16766
Thomas Gerhards, +493305552273, thomas.gerhards@sana.de
Nils Meissner, Dr. med., +493305552212, nils.meissner@sana.de
About this study
Official title: Does Cryotherapy Using Cuff Cooling Reduce Postoperative Swelling and Pain After Total Knee Arthroplasty More Effectively Than Conventional Cryotherapy Using Ice Packs?
Topic/Disease Pattern Postoperative pain and swelling management after knee prosthesis implantation using cryotherapy
Objective To determine possible differences in postoperative swelling and pain following primary total knee arthroplasty (TKA) under cryotherapy using cuff cooling versus conventional ice pack treatment.
Study Plan Treatment of the cohort using cuff cooling and comparison with a control group receiving conventional treatment with ice packs.
Study-Related Measures
Pre- and postoperative examinations according to the examination and data collection plan Evaluation after completion of full recruitment
- Being tested
- cryo cuff treatment, postoperative cooling with conventional ice pack
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryo cuff treatmentDevice
patients treated with postoperative cryo cuff cooling
postoperative cooling with conventional ice packDevice
postoperative cooling with conventional ice pack
| Study group | Role | What they receive |
|---|---|---|
| conventional ice pack | Active comparator | Patients treated with postoperative conventional ice pack cooling Receives: Device: postoperative cooling with conventional ice pack |
| postoperative cryo cuff treatment | Active comparator | postoperative cryo cuff treatment Receives: Device: cryo cuff treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative swelling
Objectively measured swelling, assessed by the circumference of the periarticular soft tissues (standardized circumference measurements performed preoperatively and postoperatively at the thigh, joint line, and lower leg with a scale, measured in cm)
Measured: from enrollment to 4 weeks postop
postoperative pain
Subjective pain perception assessed using the Numeric Rating Scale (NRS) (value 1-10, 1 meaning low pain level, 10 meaning extreme pain)
Measured: from enrollment to 4 weeks postop
Secondary outcomes (1)
postoperative painkiller demand
documented postoperative painkiller consumption (type, frequency, and dosage)
Measured: enrollment to 4 weeks postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start27 May 2026
- Primary completion1 Oct 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Swelling After TKAStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Andreas Halder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Andreas Halder, Sana Hospital Sommerfeld
- Investigators
- Andreas Halder, Prof. Dr. med., Study chair, Sana Kliniken Sommerfeld
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627854
- Sponsor's protocol ID
- 2026-47-BO-ff
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Cryotherapy Using Cuff Cooling Reduce Postoperative Swelling and Pain After Total Knee Arthroplasty More Effectively Than Conventional Cryotherapy Using Ice Packs?
- ClinicalTrials.gov ID
- NCT07627854
- Acronym / sponsor ID
- 2026-47-BO-ff
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Prof. Dr. med. Andreas HalderUniversity, hospital or other
- Study start
- 27 May 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Jun 2026 (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.
Topic/Disease Pattern Postoperative pain and swelling management after knee prosthesis implantation using cryotherapy
Objective To determine possible differences in postoperative swelling and pain following primary total knee arthroplasty (TKA) under cryotherapy using cuff cooling versus conventional ice pack treatment.
Study Plan Treatment of the cohort using cuff cooling and comparison with a control group receiving conventional treatment with ice packs.
Study-Related Measures
Pre- and postoperative examinations according to the examination and data collection plan Evaluation after completion of full recruitment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional ice pack | Active comparator | Device: postoperative cooling with conventional ice packPatients treated with postoperative conventional ice pack cooling |
| postoperative cryo cuff treatment | Active comparator | Device: cryo cuff treatmentpostoperative cryo cuff treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent form (signed by the patient and the responsible study physician)
- Primary total knee arthroplasty (TKA) Age ≥ 18 years
- Willingness to document the NRS score and subjective feeling of tightness after 4 weeks
Key exclusion criteria (6 listed)
- Obesity with BMI ≥ 40
- Lymphedema
- Lymphatic drainage therapy
- Revision total knee arthroplasty (TKA) surgeries
- Primary unicondylar knee arthroplasty
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 |
|---|---|---|
| cryo cuff treatmentpatients treated with postoperative cryo cuff cooling | Device | postoperative cryo cuff treatment |
| postoperative cooling with conventional ice packpostoperative cooling with conventional ice pack | Device | conventional ice pack |
Primary outcome
postoperative swelling
Time frame: from enrollment to 4 weeks postop
Objectively measured swelling, assessed by the circumference of the periarticular soft tissues (standardized circumference measurements performed preoperatively and postoperatively at the thigh, joint line, and lower leg with a scale, measured in cm)
postoperative pain
Time frame: from enrollment to 4 weeks postop
Subjective pain perception assessed using the Numeric Rating Scale (NRS) (value 1-10, 1 meaning low pain level, 10 meaning extreme pain)
1 secondary outcome
postoperative painkiller demand
Time frame: enrollment to 4 weeks postop
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 4 Jun 2026.
- Individual participant dataSharing planned: No
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.
Andreas Halder, Prof. Dr. med. study chair
Sana Kliniken Sommerfeld
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryo cuff treatment and postoperative cooling with conventional ice pack in people with Postoperative Swelling After TKA and Postoperative Pain After Tka, run by Prof. Dr. med. Andreas Halder at 1 site in Germany.
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 6 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 4 Jun 2026. 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 Germany. 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 Thomas Gerhards (+493305552273, thomas.gerhards@sana.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative swelling (time frame: from enrollment to 4 weeks postop). The study lists 2 primary outcomes in all. 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 4 Jun 2026.