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

NCT ID: NCT05904158

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-15
• Study Completion Date: 2022-08-20

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRF Group

Patients in this group, received PRF application during the standard ACL reconstruction surgery

Group Type: EXPERIMENTAL

Platelet-Rich Fibrin during Standard ACL reconstruction surgery

Intervention Type: BIOLOGICAL

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

Control Group

Patients in this group received a standard ACL reconstruction surgery without any other intervention.

Group Type: ACTIVE_COMPARATOR

Standard ACL reconstruction surgery

Intervention Type: OTHER

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

Interventions

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

Intervention Type: BIOLOGICAL

Standard ACL reconstruction surgery

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

SERDAR DEMIRCI

Dr. Fzt. Serdar Demirci (Director of the study)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

E-18-2060

Identifier Type: -

Identifier Source: org_study_id