Completed

NCT Number: NCT05904158

Effects of Platelet-Rich Fibrin 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.

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Key information

Conditions

Effects of Platelet-Rich Fibrin on Knee Stability and Knee Function

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet-Rich Fibrin during Standard ACL reconstruction surgery

Biological

Plateleth-rich fibrin was obtained from patients own blood (40 cc) and applied to the tunnels which were drilled for ACL graft

Standard ACL reconstruction surgery

Other

This was a control group where patients received Standard ACL reconstruction surgery

Primary outcomes

Changes in the Knee Laxity

Time frame: Preoperatively ans one year postoperatively

Knee laxity was measured using Kneelax-3 Knee arthrometer

Secondary outcomes

Changes in the Knee Muscle Strenght

Time frame: Preoperatively ans one year postoperatively

Qudriceps and hamstring muscle strength were measured using an isokinetic dynamometer
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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

Ankara City Hospital Bilkent

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2022
Study completion: 2022
First posted: Jun 15, 2023
Registry last updated: Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.