Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cryopressotherapy
DeviceComparison between Cryopressotherapy and ice pack in patients undergoing Total Knee Arthroplasty to improve clinical outcomes
Ice pack
DeviceComparison between ice pack and cryopressotherapy
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Group A: will undergo a cryopressotherapy protocol using a dedicated device/machine.Experimental treatment 1 intervention
Group B: Group B: will undergo a cryotherapy protocol using ice.Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 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
Time frame
Preoperative assessment and 14 days postoperatively.Secondary outcomes
1
Analysis of the knee Range of Motion (ROM) in the preoperative phase
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.
Time frame
Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit).2
Analysis of PROMs (Patient-Reported Outcome Measures): Oxford Knee Score (OKS)
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.
Time frame
Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit).3
Analysis of PROMs (Patient-Reported Outcome Measures): Forgotten Joint Score (FJS-12)
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.
Time frame
Pre-discharge visit; 14 days postoperatively (suture removal visit).4
Analysis of PROMs (Patient-Reported Outcome Measures): Numerical Rating Scale (NRS) for pain
Pain intensity measured using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain)
Time frame
Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit)Sponsors and contacts
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Source ClinicalTrials.gov