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

NCT07185802 | Recruiting DMC

• 1 other identifier: 5744
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament

Keywords

PRP in ACL injury

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS ): Change in pain intensity measured by Visual Analog Scale

  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 Outcomes (1)

• KOOS: Change in functional outcome measured by Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Baseline, 3 weeks, 8 weeks, and 16 weeks after intervention.

Study Arms (2)

Group A/Experimental group

EXPERIMENTAL

Will receive PRP and conventional conservative method (physical therapy, functional bracing, lifestyle modification)

Biological: PRP injection; Other: conventional conservative method (physical therapy, functional bracing, lifestyle modification)

Group B/Control group

ACTIVE COMPARATOR

Will receive conventional conservative method (physical therapy, functional bracing, lifestyle modification) only

Other: conventional conservative method (physical therapy, functional bracing, lifestyle modification)

Interventions

PRP injection BIOLOGICAL

Ultrasound guided intraarticular PRP is given to the patient with partial ACL tear

Also known as: PRP group

Group A/Experimental group

conventional conservative method (physical therapy, functional bracing, lifestyle modification) OTHER

conventional conservative method (physical therapy, functional bracing, lifestyle modification)

Also known as: Rehabilitation

Group A/Experimental group; Group B/Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both sexes who are older than 18 years and younger than 50 years
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Interventions

Physical Therapy Modalities; Rehabilitation

Intervention Hierarchy (Ancestors)

Therapeutics; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Dr. Isfath Fauzia, MBBS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

• Prof. Dr. Md. Ali Emran, MBBS, FCPS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  STUDY CHAIR

• 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 DIRECTOR

Central Study Contacts

Dr. Isfath Fauzia, MBBS

CONTACT

+8801744801604; isfathfauzia20@gmail.com

Prof. Dr. Md. Ali Emran, MBBS, FCPS

CONTACT

+8801716161616; emran68@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 22, 2025
• Study Start: August 27, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 26, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

BA (1)