Effects of Platelet-Rich Fibrin in Patients With Anterior Cruciate Ligament Reconstruction

June 6, 2023 updated by: SERDAR DEMIRCI, Hacettepe University

Effects of Platelet-Rich Fibrin on Knee Muscle Strength and Function in Patients With Anterior Cruciate Ligament Reconstruction

The study was conducted to investigate the effects of platelet-rich fibrin on knee stability, knee muscle strength and knee function in patients with ACL reconstruction. Thirty patients with ACL reconstruction were included to the study and randomly divided into two groups. Patients were assessed preoperative and at the postoperative 1-year.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was conducted yo investigate the effects of platelet-rich fibrin (PRF) on the knee stability and function in patients with anterior cruciate ligament (ACL) reconstruction. Thirty patients with ACL reconstruction were included to the study and randomly divided into two groups (PRF group and control group). Hamstring tendon autograft was used in all patients for the reconstruction of the teared ACL. A standardized postoperative rehabilitation program was applied to all patients. Patients' knee stability, knee muscle strength and knee function were assessed preoperatively and one-year postoperatively. Knee stability was assessed using KT-2000 Knee Arthrometer. Quadriceps femoris and hamstring muscle strength measurements were conducted with an isokinetic dynamometer at 60˚/sec and 180˚/sec angular velocities. One Leg Hop (OLH) and Y-Balance tests, and International Knee Documentation Committee (IKDC) were used to evaluate the knee function.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being isolated ACL reconstruction,
  • Being between the ages of 18-45 years,
  • Performing sports recreationally or professionally

Exclusion Criteria:

  • Having previous knee surgery,
  • Having systematic disease,
  • Having multiple ligament injury on the knee or additional cartilage injuries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRF Group
Patients in this group, received PRF application during the standard ACL reconstruction surgery
Biological: Platelet-Rich Fibrin during Standard ACL reconstruction surgery
Plateleth-rich fibrin was obtained from patients own blood (40 cc) and applied to the tunnels which were drilled for ACL graft
Active Comparator: Control Group
Patients in this group received a standard ACL reconstruction surgery without any other intervention.
Other: Standard ACL reconstruction surgery
This was a control group where patients received Standard ACL reconstruction surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Knee Laxity
Time Frame: Preoperatively ans one year postoperatively
Knee laxity was measured using Kneelax-3 Knee arthrometer
Preoperatively ans one year postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Knee Muscle Strenght
Time Frame: Preoperatively ans one year postoperatively
Qudriceps and hamstring muscle strength were measured using an isokinetic dynamometer
Preoperatively ans one year postoperatively
Changes in the Knee Function
Time Frame: Preoperatively and one year postoperatively
Knee function was assessed with one leg hop (OLH) test and Y-Balance tests
Preoperatively and one year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2010

Primary Completion (Actual)

August 20, 2022

Study Completion (Actual)

August 20, 2022

Study Registration Dates

First Submitted

May 27, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-18-2060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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