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NCT Number: NCT07627854

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

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

Recruiting

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Key information

Conditions

Postoperative Swelling After TKA Postoperative Pain After Tka

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cryo cuff treatment

Device

patients treated with postoperative cryo cuff cooling

postoperative cooling with conventional ice pack

Device

postoperative cooling with conventional ice pack

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. postoperative painkiller demand

    Time frame: enrollment to 4 weeks postop

    documented postoperative painkiller consumption (type, frequency, and dosage)

Study contacts

Contact information is provided by the study sponsor or research team.

Nils Meisser, Dr. med.

CONTACT

[email protected]

+493305552212

Thomas Gerhards

CONTACT

[email protected]

+493305552273

Sponsors and collaborators

Lead sponsor

Prof. Dr. med. Andreas Halder

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.