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
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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COMPLETED
NA
12 participants
INTERVENTIONAL
2020-01-20
2021-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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
total knee replacement surgery
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
total knee replacement surgery
total knee replacement surgery
Interventions
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total knee replacement surgery
total knee replacement surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* Systemic disorders such as diabetes, rheumatic diseases;
* Patients with malignancy;
* Thyroid metabolic disorders ;
* Abuse of alcohol, drugs and pharmaceutical drugs
* Body mass index \> 40;
50 Years
80 Years
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Locations
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IRCCS Itituto Ortopedico Rizzoli
Bologna, BO, Italy
Countries
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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.
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.
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.
Other Identifiers
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Fibrin4Fast
Identifier Type: -
Identifier Source: org_study_id
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