RecruitingNot ApplicableNCT07456787

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

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Enrollment

78 participants

Start Date

Sep 29, 2025

Study Type

INTERVENTIONAL

Conditions

Total Knee Arthroplasty (TKA)Osteoartrosi

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

Candidates for elective total knee arthroplasty surgery (indication determined solely by the Orthopedic Surgeon)
Patients aged between 18 and 80 years (inclusive) for both groups
Body Mass Index (BMI) between 18 and 35 kg/m²
Willingness and ability to provide informed consent
Patients with non-inflammatory degenerative knee joint disease, including osteoarthritis

Exclusion Criteria7

Use of medications that may interfere with muscle metabolism
Bone metastases or diseases at the surgical site
Presence or suspicion of infection at the knee
Inability to provide informed consent
Obesity (BMI ≥ 35 kg/m²)
Patients requiring revision surgery of total knee arthroplasty
Patients with pacemakers and/or mechanical implants or those who may be affected by BIA interference