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
Qualifiers
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
Treatments tested in this trial
- Cryopressotherapy
- Ice pack
Treatment groups
78 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov