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

NCT ID: NCT04165863

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2021-11-04

Brief Summary

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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

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Conditions

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Knee Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

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

Group Type EXPERIMENTAL

total knee replacement surgery

Intervention Type PROCEDURE

total knee replacement surgery

B

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

Group Type ACTIVE_COMPARATOR

total knee replacement surgery

Intervention Type PROCEDURE

total knee replacement surgery

Interventions

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total knee replacement surgery

total knee replacement surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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;
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Itituto Ortopedico Rizzoli

Bologna, BO, Italy

Site Status

Countries

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Italy

References

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Harato K, Tanikawa H, Morishige Y, Kaneda K, Niki Y. What are the important surgical factors affecting the wound healing after primary total knee arthroplasty? J Orthop Surg Res. 2016 Jan 13;11:7. doi: 10.1186/s13018-016-0340-y.

Reference Type RESULT
PMID: 26762213 (View on PubMed)

Galat DD, McGovern SC, Larson DR, Harrington JR, Hanssen AD, Clarke HD. Surgical treatment of early wound complications following primary total knee arthroplasty. J Bone Joint Surg Am. 2009 Jan;91(1):48-54. doi: 10.2106/JBJS.G.01371.

Reference Type RESULT
PMID: 19122078 (View on PubMed)

Rui M, Zheng X, Sun SS, Li CY, Zhang XC, Guo KJ, Zhao FC, Pang Y. A prospective randomised comparison of 2 skin closure techniques in primary total hip arthroplasty surgery. Hip Int. 2018 Jan;28(1):101-105. doi: 10.5301/hipint.5000534.

Reference Type RESULT
PMID: 29148019 (View on PubMed)

Other Identifiers

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Fibrin4Fast

Identifier Type: -

Identifier Source: org_study_id

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