Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional ice pack | Active Comparator | Patients treated with postoperative conventional ice pack cooling |
|
| postoperative cryo cuff treatment | Active Comparator | postoperative cryo cuff treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cryo cuff treatment | Device | patients treated with postoperative cryo cuff cooling |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | from enrollment to 4 weeks postop |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative painkiller demand | documented postoperative painkiller consumption (type, frequency, and dosage) | enrollment to 4 weeks postop |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Gerhards | Contact | +493305552273 | thomas.gerhards@sana.de | |
| Nils Meisser, Dr. med. | Contact | +493305552212 | nils.meissner@sana.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Halder, Prof. Dr. med. | Sana Kliniken Sommerfeld | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sana Kliniken Sommerfeld | Recruiting | Kremmen | Brandenburg | 16766 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| postoperative cooling with conventional ice pack | Device | postoperative cooling with conventional ice pack |
|