NCT04165863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2021

Completed
Last Updated

January 19, 2022

Status Verified

November 1, 2019

Enrollment Period

1.8 years

First QC Date

November 14, 2019

Last Update Submit

January 18, 2022

Conditions

Knee Disease

Outcome Measures

Primary Outcomes (1)

  • clinical improvement of the healing process

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

    2 weeks

Secondary Outcomes (1)

  • Dermatology life quality

    3 days, 15 days and 1 month

Study Arms (2)

A

EXPERIMENTAL

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

Procedure: total knee replacement surgery

B

ACTIVE COMPARATOR

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

Procedure: total knee replacement surgery

Interventions

total knee replacement surgeryPROCEDURE

total knee replacement surgery

AB

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Itituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

Related Publications (3)

  • 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.

    PMID: 26762213RESULT

  • 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.

    PMID: 19122078RESULT

  • 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.

    PMID: 29148019RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 18, 2019

Study Start

January 20, 2020

Primary Completion

November 4, 2021

Study Completion

November 4, 2021

Last Updated

January 19, 2022

Record last verified: 2019-11

Locations

IT(1)