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?

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 Overview

• Status: Recruiting
• Conditions: Postoperative Swelling After TKA; Postoperative Pain After Tka
• Intervention / Treatment: Device: postoperative cooling with conventional ice pack; Device: cryo cuff treatment

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Gerhards; Phone Number: +493305552273; Email: thomas.gerhards@sana.de
• Study Contact Backup: Name: Nils Meisser, Dr. med.; Phone Number: +493305552212; Email: nils.meissner@sana.de

Study Locations

• Germany
  • Brandenburg
    • Kremmen, Brandenburg, Germany, 16766
      • Recruiting
      • Sana Kliniken Sommerfeld
      • Contact: Thomas Gerhards; Phone Number: +493305552273; Email: thomas.gerhards@sana.de
      • Contact: Nils Meissner, Dr. med.; Phone Number: +493305552212; Email: nils.meissner@sana.de
      • Sub-Investigator: Thomas Gerhards

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional ice pack; Patients treated with postoperative conventional ice pack cooling	Device: postoperative cooling with conventional ice pack; postoperative cooling with conventional ice pack
Active Comparator: postoperative cryo cuff treatment	Device: cryo cuff treatment; patients treated with postoperative cryo cuff cooling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Prof. Dr. med. Andreas Halder
• Investigators: Study Chair: Andreas Halder, Prof. Dr. med., Sana Kliniken Sommerfeld

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026-47-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No