Effectiveness of Treatment With Rich Platelet Fibrin (PRF) VS Gold Standard in Patients Undergoing Knee Replacement (Fibrin4Fast)

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Knee Disease

Treatments: Procedure: total knee replacement surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04165863

Fibrin4Fast

Details and patient eligibility

About

Randomized controlled single blind trial for the evaluation of the treatment of the surgical wound healing process with Platelet-Rich-Fibrin compared to the gold standard (without Platelet-Rich-Fibrin) in patients undergoing knee replacement.

Enrollment: 12 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females undergoing a total knee prosthesis.
• Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
• Hb > 11 g/dl; Platelet value > 150.000 plt/mmc;
• Patients with non clinical alteration of ECG;
• Signature of informed consent;

Exclusion criteria

• Patients incapable of understanding and of wanting;
• Systemic disorders such as diabetes, rheumatic diseases;
• Patients with malignancy;
• Thyroid metabolic disorders ;
• Abuse of alcohol, drugs and pharmaceutical drugs
• Body mass index > 40;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

A

Experimental group

Description:

treatment of the surgical wound healing process with Platelet-rich-fibrin in patients undergoing total knee replacement surgery

Treatment:

Procedure: total knee replacement surgery

B

Active Comparator group

Description:

Gold standard treatment of the surgical wound healing process without Platelet-rich-fibrin in patients undergoing total knee replacement surgery

Treatment:

Procedure: total knee replacement surgery