Postoperative Cryocuff vs. Conventional Icepack in TKA - What is More Effective in Reducing Pain and Swelling?

Does Cryotherapy Using Cuff Cooling Reduce Postoperative Swelling and Pain After Total Knee Arthroplasty More Effectively Than Conventional Cryotherapy Using Ice Packs?

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07627854

Enrollment

102

Registered

2026-06-04

Start date

2026-05-27

Completion date

2027-05-01

Last updated

2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain After Tka, Postoperative Swelling After TKA

Brief 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 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

Interventions

DEVICEcryo cuff treatment

patients treated with postoperative cryo cuff cooling

DEVICEpostoperative cooling with conventional ice pack

postoperative cooling with conventional ice pack

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
postoperative swelling	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	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)

Secondary

Measure	Time frame	Description
postoperative painkiller demand	enrollment to 4 weeks postop	documented postoperative painkiller consumption (type, frequency, and dosage)

Countries

Germany

Contacts

CONTACTThomas Gerhards

thomas.gerhards@sana.de+493305552273

CONTACTNils Meisser, Dr. med.

nils.meissner@sana.de+493305552212

STUDY_CHAIRAndreas Halder, Prof. Dr. med.

Sana Kliniken Sommerfeld

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026