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

Phase 4

Completed

• Conditions: Effects of Platelet-Rich Fibrin on Knee Stability and Knee Function
• Interventions: Biological: Platelet-Rich Fibrin during Standard ACL reconstruction surgery; Other: Standard ACL reconstruction surgery

• Registration Number: NCT05904158
• Lead Sponsor: Hacettepe University

Brief Summary

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.

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 Timeline

• Study Start: 2010-06-15
• Primary Completion: 2022-08-20
• Study Completion: 2022-08-20
• Study First Submitted: 2023-05-27
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-06
• Last Update Submitted: 2023-06-06
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRF Group	Platelet-Rich Fibrin during Standard ACL reconstruction surgery	Patients in this group, received PRF application during the standard ACL reconstruction surgery
Control Group	Standard ACL reconstruction surgery	Patients in this group received a standard ACL reconstruction surgery without any other intervention.

Primary Outcome Measures

Name	Time	Method
Changes in the Knee Laxity	Preoperatively ans one year postoperatively	Knee laxity was measured using Kneelax-3 Knee arthrometer

Secondary Outcome Measures

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