Total Knee Arthroplasty\(TKA\), Osteoartrosi
Conditions
Brief 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.
Interventions
DEVICECryopressotherapy
Comparison between Cryopressotherapy and ice pack in patients undergoing Total Knee Arthroplasty to improve clinical outcomes
DEVICEIce pack
Comparison between ice pack and cryopressotherapy
Sponsors
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of the knee Range of Motion (ROM) in the preoperative phase | Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit). | Knee range of motion (ROM) measured in degrees using a goniometer. Flexion and extension will be recorded. Higher flexion values indicate better joint mobility, while lower extension deficit values indicate better functional outcome. |
| Analysis of PROMs (Patient-Reported Outcome Measures): Oxford Knee Score (OKS) | Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit). | The Oxford Knee Score (OKS) is a 12-item patient-reported outcome measure assessing pain and function in patients undergoing knee surgery. Each item is scored from 0 to 4. The total score ranges from 0 to 48, with higher scores indicating better knee function. |
| Analysis of PROMs (Patient-Reported Outcome Measures): Forgotten Joint Score (FJS-12) | Pre-discharge visit; 14 days postoperatively (suture removal visit). | The Forgotten Joint Score-12 (FJS-12) is a 12-item questionnaire evaluating joint awareness during daily activities. Scores range from 0 to 100, with higher scores indicating better outcome and less joint awareness. |
| Analysis of PROMs (Patient-Reported Outcome Measures): Numerical Rating Scale (NRS) for pain | Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit) | Pain intensity measured using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain) |
| Analysis of PROMs (Patient-Reported Outcome Measures): Short Form-12 Health Survey (SF-12) | Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit) | The Short Form-12 (SF-12) is a validated questionnaire assessing health-related quality of life. It provides a Physical Component Summary (PCS) and a Mental Component Summary (MCS). Higher scores indicate better health status |
| Improvement in hemoglobin (Hb) levels | Preoperative assessment and pre-discharge visit | Hemoglobin (Hb) levels measured in g/dL through standard blood testing. The change from preoperative baseline to postoperative assessment will be evaluated. Higher postoperative Hb levels indicate reduced blood loss. |
| Change in operated limb circumference | Preoperative assessment; pre-discharge visit; 14 days postoperatively. | Operated limb circumference measured in centimeters (cm) using a measuring tape at standardized anatomical reference points. The change from preoperative baseline will be calculated. A reduction in circumference indicates decreased postoperative swelling. |
Countries
Italy
Contacts
CONTACTLaura Mangiavini
PRINCIPAL_INVESTIGATORLaura Mangiavini
University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio
Outcome results
None listed