Clinical Outcome of Intra Articular Injection of Autologous Platelet Rich Plasma in Anterior Cruciate Ligament Injury. (ACL)

September 19, 2025 updated by: Isfath Fauzia, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

This clinical trial will evaluate the effectiveness of platelet-rich plasma (PRP) injections for patients with anterior cruciate ligament (ACL) injury. ACL injuries commonly cause knee instability, pain, and reduced function, and rehabilitation alone may not fully restore recovery in all patients. PRP is prepared from a small sample of the patient's own blood and contains natural growth factors that may promote healing and improve joint function.

In this study, participants will be randomly assigned to one of two groups. The experimental group will receive a single ultrasound-guided injection of PRP into the knee joint along with a standard rehabilitation program. The control group will receive the rehabilitation program alone.

Participants will be followed up at 3 weeks, 8 weeks, and 16 weeks after treatment. At each follow-up visit, knee function, pain level, and physical performance will be assessed using validated outcome measures. The primary aim is to determine whether PRP provides additional benefit compared with rehabilitation alone in improving function and reducing symptoms in ACL-injured patients.

This study will provide new evidence about the role of PRP in ACL management, which may help guide future treatment decisions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Prof. Dr. Md. Ali Emran, MBBS, FCPS
  • Phone Number: +8801716161616
  • Email: emran68@yahoo.com

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Recruiting
        • Bangabandhu Sheikh Mujib Medical University
        • Contact:
        • Principal Investigator:
          • Dr. Isfath Fauzia, MBBS
        • Sub-Investigator:
          • Dr. Nazmul Hassan, MBBS

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:

  • Patients of both sexes who are older than 18 years and younger than 50 years
  • 3 or Less than 3-months history of knee injuries
  • ACL injury MRI Grade 1 (Low) and medium Grade 2 (Medium) grade
  • ACL injury associated with Grade 1 or 2 Posterior cruciate ligament (PCL) tear and/or Grade 1 or 2 meniscal tear
  • The Complete Blood Count (CBC) report shows a hemoglobin > 10gm/dl and platelet count >150,000/microliter prior to the procedure
  • Capable of comprehending informed consent

Exclusion criteria:

  • Patients who have had intra articular corticosteroid injections in the index knee during the last 12 weeks
  • Patients who are taking systemic steroid
  • Patients who are younger than 18 and older than 50 years
  • Those with a history of platelet disorders or on the therapeutic anticoagulant or anti platelet drugs
  • Hemoglobin below 10 gm/dl
  • Platelet count <150000/microliter
  • Complete tear of both bundles on MRI
  • Grade 3 or more PCL and meniscal tear on MRI
  • Previous or concurrent ligament reconstruction in the index knee joint.
  • Connective tissue disorders like Marfan Syndrome, Ehler-Danlos Syndrome etc.
  • Any inflammatory disease like Rheumatoid Arthritis, spondyloarthritis, gout, pseudogout etc involving the knee joint.

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: Group A/Experimental group
Will receive PRP and conventional conservative method (physical therapy, functional bracing, lifestyle modification)
Biological: PRP injection
Ultrasound guided intraarticular PRP is given to the patient with partial ACL tear
Other Names:
  • PRP group
Other: conventional conservative method (physical therapy, functional bracing, lifestyle modification)
conventional conservative method (physical therapy, functional bracing, lifestyle modification)
Other Names:
  • Rehabilitation
Active Comparator: Group B/Control group
Will receive conventional conservative method (physical therapy, functional bracing, lifestyle modification) only
Other: conventional conservative method (physical therapy, functional bracing, lifestyle modification)
conventional conservative method (physical therapy, functional bracing, lifestyle modification)
Other Names:
  • Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS ): Change in pain intensity measured by Visual Analog Scale
Time Frame: Baseline, 3 weeks, 8 weeks, and 16 weeks after intervention.
Pain intensity will be assessed using the Visual Analog Scale (0 = no pain, 10 = worst possible pain).
Baseline, 3 weeks, 8 weeks, and 16 weeks after intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS: Change in functional outcome measured by Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline, 3 weeks, 8 weeks, and 16 weeks after intervention.
KOOS assesses five domains: pain, symptoms, activities of daily living, sport/recreation function, and knee-related quality of life.
Baseline, 3 weeks, 8 weeks, and 16 weeks after intervention.

Collaborators and Investigators

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

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

  • Principal Investigator: Dr. Isfath Fauzia, MBBS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  • Study Chair: Prof. Dr. Md. Ali Emran, MBBS, FCPS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  • Study Director: Dr. Md. Nuruzzaman Khandaker, MBBS, FCPS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  • Study Director: Dr. Md. Tariqul Islam, MBBS, FCPS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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)

August 27, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

August 26, 2026

Study Registration Dates

First Submitted

September 19, 2025

First Submitted That Met QC Criteria

September 19, 2025

First Posted (Actual)

September 22, 2025

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5744

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

I will think later in case of mind change

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.

Clinical Trials on Anterior Cruciate Ligament

Clinical Trials on PRP injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe