Platelet-rich Plasma and Synovial Cytokines in Knee Osteoarthritis

NCT04754685 | Completed

• 1 other identifier: SVU-QFM-102
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Platelet rich plasma; Knee osteoarthritis; MRI Osteoarthritis Knee Score; pain score; synovial fluid; tumor necrosis factor-α; macrophage migration inhibitory factor

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  one year

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

  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.

  one year

• 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).

  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).

  one year

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

  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

  one year

Study Arms (3)

Mild knee osteoarthritis

ACTIVE COMPARATOR

30 patients had mild knee osteoarthritis

Drug: Intra-articular injection of platelet-rich plasma

Moderate knee osteoarthritis

ACTIVE COMPARATOR

30 patients had moderate knee osteoarthritis

Drug: Intra-articular injection of platelet-rich plasma

Severe knee osteoarthritis

ACTIVE COMPARATOR

30 patients had severe knee osteoarthritis

Drug: Intra-articular injection of platelet-rich plasma

Interventions

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

Also known as: PRP injection

Mild knee osteoarthritis; Moderate knee osteoarthritis; Severe knee osteoarthritis

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients have unilateral knee OA

You may not qualify if:

• 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

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Faculty of Medicine, South valley University

Qina, Qena Governorate, 83523, Egypt

Location

Related Publications (3)

• Taniguchi Y, Yoshioka T, Kanamori A, Aoto K, Sugaya H, Yamazaki M. Intra-articular platelet-rich plasma (PRP) injections for treating knee pain associated with osteoarthritis of the knee in the Japanese population: a phase I and IIa clinical trial. Nagoya J Med Sci. 2018 Feb;80(1):39-51. doi: 10.18999/nagjms.80.1.39.

  PMID: 29581613 RESULT

• Hunter DJ, Guermazi A, Lo GH, Grainger AJ, Conaghan PG, Boudreau RM, Roemer FW. Evolution of semi-quantitative whole joint assessment of knee OA: MOAKS (MRI Osteoarthritis Knee Score). Osteoarthritis Cartilage. 2011 Aug;19(8):990-1002. doi: 10.1016/j.joca.2011.05.004. Epub 2011 May 23.

  PMID: 21645627 RESULT

• Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-52. doi: 10.1016/s0039-6109(05)70381-9.

  PMID: 10352653 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mohammed H Hassan, MD

  Faculty of Medicine- South Valley University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medical Biochemistry, Faculty of Medicine , South Valley University

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 15, 2021
• Study Start: February 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: March 14, 2020
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)