NCT07456787

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Knee osteoarthritis is a degenerative condition that causes cartilage wear, leading to pain, stiffness, and difficulty moving. It mainly affects older adults, but it can also occur in younger individuals in cases of genetic predisposition or trauma. Symptoms include pain during or after physical activity, swelling, and difficulty walking. Initial treatment is based on physiotherapy, anti-inflammatory medications, and injections, but if the disease progresses, a total knee replacement with a prosthesis may become necessary. Modern prostheses are made with advanced materials and minimally invasive surgical techniques, improving postoperative recovery. Using ice in the first few days after surgery is crucial to reducing pain and swelling, improving functional recovery, and lowering the need for pain medications, such as opioids. Moreover, ice therapy promotes early rehabilitation and reduces hospitalization time. Cryotherapy may also help lower healthcare costs thanks to more effective pain management. Advanced continuous cooling devices, although promising, require further studies to confirm their effectiveness. The aim of the study is therefore to assess whether the cryopressotherapy protocol leads to an improvement in clinical outcomes in patients undergoing total knee arthroplasty (TKA), earlier mobilization, and reduced use of pain medication.

Conditions

• Total Knee Arthroplasty\(TKA\)
• Osteoartrosi

Interventions

Type	Name	Description
DEVICE	Cryopressotherapy	Comparison between Cryopressotherapy and ice pack in patients undergoing Total Knee Arthroplasty to improve clinical outcomes
DEVICE	Ice pack	Comparison between ice pack and cryopressotherapy

Timeline

• Start date: 2025-09-29
• Primary completion: 2025-10-13
• Completion: 2028-02-01
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: Italy