NCT07456787 Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome
| NCT ID | NCT07456787 |
| Status | Recruiting |
| Phase | — |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio |
| Condition | Total Knee Arthroplasty\(TKA\) |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-09-29 |
| Primary Completion | 2025-10-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 78 participants in total. It began in 2025-09-29 with a primary completion date of 2025-10-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Laura Mangiavini
PRINCIPAL INVESTIGATOR
University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio
Frequently Asked Questions
Who can join the NCT07456787 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Total Knee Arthroplasty\(TKA\). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07456787 currently recruiting?
Yes, NCT07456787 is actively recruiting participants. Contact the research team at laura.mangiavini@unimi.it for enrollment information.
Where is the NCT07456787 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07456787 clinical trial?
NCT07456787 is sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. The principal investigator is Laura Mangiavini at University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio. The trial plans to enroll 78 participants.