Skip to main content
OpenTrials
Completed

NCT Number: NCT04754685

Platelet-rich Plasma and Synovial Cytokines in Knee Osteoarthritis

A prospective study was performed on 90 patients were included and categorized into mild (30 cases, moderate (30 cases) and severe (30 cases) knee OA. Three intra-articular (I.A) injections of PRP, 2 weeks a part, were received. Pain score and MRI Osteoarthritis Knee Score (MOAKS) were assessed. Serial synovial fluid cytokines assays in the form of Tumor necrosis factor-α (TNF-α) and Macrophage migration inhibitory factor (MIF), were performed using commercially available ELISA assay kits. The assays were performed pre-injection (S1), two weeks from the 1st I.A injection and two weeks from the 2nd I.A injection (S3) for all included patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, South valley University

Qina, Qena Governorate, 83523, Egypt

About this study

Background: Osteoarthritis (OA) is a multifactorial disease that commonly affects the knee. Tumor necrosis factor-α (TNF-α) is able to regulate inflammation in OA. Macrophage migration inhibitory factor (MIF) may be involved in the pathophysiology of arthritis. Platelet-rich plasma (PRP) may reduce pain associated with OA. The current study aimed to assess the possible therapeutic effects of PRP in patients with knee OA of various severities.

Methods: A prospective study was performed on 90 patients were included and categorized into mild (30 cases, moderate (30 cases) and severe (30 cases) knee OA. Three intra-articular (I.A) injections of PRP, 2 weeks a part, were received. Pain score and MRI Osteoarthritis Knee Score (MOAKS) were assessed. Serial synovial fluid cytokines assays in the form of Tumor necrosis factor-α (TNF-α) and Macrophage migration inhibitory factor (MIF), were performed using commercially available ELISA assay kits. The assays were performed pre-injection (S1), two weeks from the 1st I.A injection and two weeks from the 2nd I.A injection (S3) for all included patients.

PRP preparation: The PRP needed for IA injection has been prepared under complete aseptic conditions. In order to avoid the effect of food intake on purified PRP, on the day of injection the patients were instructed to fast for 4 hours before blood collection. Approximately 20 mL of venous blood were drawn from the antecubital vein using an aseptic technique in an effort to avoid irritation and trauma to the platelets. Anti-coagulated blood was obtained in ten extraction tubes (2 mL each), containing sodium citrate. The tubes were then centrifuged at 2100 rpm at room temperature for 8 minutes to separate the blood in each tube into the citrated plasma, the buffy coat and the residual red blood cells ( RBCs) . Using a pipette, the PRP situated just above the selectively precipitated RBCs but not including the buffy coat was carefully aspirated from each tube. In each affected joint, 10-mL PRP samples (from the collected venous blood) were used for IA injection . For each intra-articular injection new fresh PRP samples were made from the patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients have unilateral knee OA

Exclusion criteria

  • Polyarticular disease.
  • Knee arthroscopy in the previous year.
  • HA or steroid IA penetration in the preceding 3 months.
  • History of infectious disease and autoimmune disorders such as diabetes, rheumatoid arthritis.
  • Hematologic diseases (coagulopathy).
  • Serious cardiovascular diseases , infections or immunodepression.
  • Anticoagulant therapy or an anti-aggregating agent.
  • Uuse of non-steroidal anti-inflammatory drugs 2 weeks prior to blood sampling.
  • < 10 g / dL of hemoglobin

Treatment and study plan

Intra-articular injection of platelet-rich plasma

Drug

The patient was put in 20 degree flexion in supine position with the knee. Under aseptic conditions, a 21-gage needle was used to inject 5 mL of PRP into the suprapatellar knee joint pouch, using a superolateral method. Local anesthetics were not used. Patients were instructed after the injection to refrain from physical exercise for at least 24 hours but no restriction was specified regarding activities of daily living. Three IA-PRP injections were administered at 2-week intervals. The same physician who was engaged in selecting and testing participants did the injections

Other names: PRP injection

Primary outcomes

  1. Changes in Pain Scores in patients with various severities of knee OA following intra-articular injection of PRP at 0, and 2 weeks from the second injection (0,4 weeks).

    Time frame: one year

    Using Visual Analog Scale (VAS) score to assess the pain score in patients with knee osteoarthritis will be done twice , pre-intra-articular injection of PRP and 2 weeks from the second I.A injection of PRP.

    The VAS is a common tool that uses a 10 cm scale for pain intensity measurement, where 0= no pain and 10= unable to move.

  2. Changes in the synovial fluid concentration of the TNF-α and MIF levels folllowing PRP injection, using ELISA assay kits.

    Time frame: one year

    Using ELISA assay kits, synovial fluid concentration of both TNF-α and MIF levels will be measured three times for the same patient (before injection, 2 weeks from the first injection and 2 weeks from the second injection) to explore the serial changes in their levels following IA i injection PRP.

  3. Changes in MRI Osteoarthritis Knee Score (MOAKS) in patients with various severities of knee OA following intra-articular injection of PRP at 0, and 2 weeks from the second injection (0,4 weeks).

    Time frame: one year

    Regarding MRI knee score will be done twice , pre-intra-articular injection of PRP and 2 weeks from the second I.A injection of PRP.

    For assessment of both bone marrow abnormality or patella-femoral cartilage volume (grade I (mild if the lesion involves ˂33% of subregional volume); grade II (Moderate: if the lesion involves 33%- 66% of subregional volume), and grade III (severe: if the lesion involves ˃ 66% of subregional volume).Regarding synovitis: grade 1 (mild or small - fluid continuous in the retropatellar space); grade 2 (Moderate or medium - slight convexity of the suprapatellar bursa), and grade 3 (severe or large - evidence of capsular distension ). Meniscal desintegrity score of 0-3 applied for amount of extrusion in 4 locations: medial meniscus (medial and anterior extrusion) and lateral meniscus (medial and anterior extrusion).

  4. Assess the correlations of synovial fluid TNF-α and MIF levels with both pain and radiological scores will performed among these patients.

    Time frame: one year

    Correlate visual Analog pain Scale and MRI Osteoarthritis Knee Score with the pre-injection cytokine synovial levels and synovial level values 2 weeks from the second IA injection of PRP

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Assessments of Therapeutic Effects of Platelet-rich Plasma in Knee Osteoarthritis: Possible Role of Inflammatory Cytokines

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2021
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.