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

Not Applicable

Completed

• Conditions: Knee Disease
• Interventions: Procedure: total knee replacement surgery

• Registration Number: NCT04165863
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-18
• Study Start: 2020-01-20
• Primary Completion: 2021-11-04
• Study Completion: 2021-11-04
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	total knee replacement surgery	treatment of the surgical wound healing process with Platelet-rich-fibrin in patients undergoing total knee replacement surgery
B	total knee replacement surgery	Gold standard treatment of the surgical wound healing process without Platelet-rich-fibrin in patients undergoing total knee replacement surgery

Primary Outcome Measures

Name	Time	Method
clinical improvement of the healing process	2 weeks	Clinical improvement of the healing process, assessed by application of the Hollander Wound Evaluation Scales at 2 weeks of follow up

Secondary Outcome Measures

Name	Time	Method
Dermatology life quality	3 days, 15 days and 1 month	Dermatology life quality index improvement at 3 days, 15 days and 1 month

Trial Locations

Locations (1)

IRCCS Itituto Ortopedico Rizzoli; 🇮🇹 Bologna, BO, Italy