Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07456787

Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome

Led by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Updated on 2026-03-06

78

Participants Needed

1

Research Sites

122 weeks

Total Duration

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AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the effectiveness of cryopressotherapy in patients undergoing total knee arthroplasty by assessing clinical improvement using the KOOS at 14 days after surgery. Analysis of the knee Range of Motion (ROM) in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery. Analysis of PROMs such as: Oxford Knee Score (OKS), Joint Forgotten (JF), NRS score, and SF-12. These questionnaires will be collected in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery. To evaluate whether cryopressotherapy leads to an improvement in predischarge hemoglobin (Hb) levels. To assess whether cryopressotherapy reduces the circumference and subcutaneous fluid accumulation of the operated limb.

CONDITIONS

Official Title

Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Candidates for elective total knee arthroplasty surgery as determined by an orthopedic surgeon
  • Aged between 18 and 80 years inclusive
  • Body Mass Index (BMI) between 18 and 35 kg/m8
  • Willing and able to provide informed consent
  • Diagnosed with non-inflammatory degenerative knee joint disease, including osteoarthritis
Not Eligible

You will not qualify if you...

  • Use of medications that interfere with muscle metabolism
  • Presence of bone metastases or diseases at the surgical site
  • Presence or suspicion of infection in the knee
  • Unable to provide informed consent
  • Obesity with BMI equal to or greater than 35 kg/m8
  • Need for revision surgery of total knee arthroplasty
  • Presence of pacemakers, mechanical implants, or conditions affected by BIA interference

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Milan 20173

Milan, Italy, Italy, 20157

Actively Recruiting

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Research Team

L

Laura Mangiavini

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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