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Recruiting NCT07185802

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

No phase Interventional Anterior Cruciate Ligament

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PRP injection, conventional conservative method (physical therapy, functional bracing, lifestyle modification).
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Bangladesh
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Biological PRP injection
    Ultrasound guided intraarticular PRP is given to the patient with partial ACL tear
  • Other conventional conservative method (physical therapy, functional bracing, lifestyle modification)
    conventional conservative method (physical therapy, functional bracing, lifestyle modification)

Primary outcome measures

  • 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.]
Secondary outcome measures (1)
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Bangladesh · 1 center
  • Bangabandhu Sheikh Mujib Medical University — Dhaka

Identifiers

NCT: NCT07185802 · 5744

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗