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

Condition(s) studied

Investigational drug(s) / intervention(s)

Cryopressotherapy: Comparison between Cryopressotherapy and ice pack in patients undergoing Total Knee Arthroplasty to improve clinical outcomes

Ice pack: Comparison between ice pack and cryopressotherapy

Study 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

Primary outcome measure(s)

• Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 14 Days Postoperatively — Preoperative assessment and 14 days postoperatively.
  The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a patient-reported questionnaire consisting of 5 subscales: Pain, Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function, and Knee-Related Quality of Life. Each subscale is scored separately and transformed to a 0-100 scale, where 0 represents extreme knee problems and 100 represents no knee problems. The outcome measure is the change from preoperative baseline to 14 days postoperatively in KOOS scores

Trial sites (1)

More I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio trials in Italy