NCT05837494

Intra Articular Injection of Ozone With Corticosteroids vs PRGF in Knee Osteoarthritis

Comparative Study Between Intra Articular Injection of Ozone With Corticosteroids Versus Plasma Rich in Growth Factors in Limitation of Pain in Knee Osteoarthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the effectiveness of intra-articular injection of ozone with corticosteroids versus plasma rich in growth factors (PRGF) in improvement of pain in knee osteoarthritis patients.

Detailed description

Knee osteoarthritis (OA) is a prevalent degenerative condition in which functional impairment is caused by mechanical and chemical stress against the joint, resulting in pain and decreased range of motion (ROM) . A multiplicity of treatments has been suggested for this disease : some of which include patient education, medication, exercise prescription, conventional and physical agent modalities such as pulsed radio-frequency, and surgical management , The current therapeutic options available for knee osteoarthritis are not effective and satisfactory for patients, and pain has been complained of by at least 40% of those cases who underwent surgical arthroplasty , Also old age prevalence of knee osteoarthritismake treatment with analgesics has several side effects over stomach, liver and kidney and also surgical one has high morbidities and mortalities for old ages. Therefore, in the last two decades, a large body of work has been performed to develop non-operative or minimally invasive interventions to decrease Knee osteoarthritis symptoms or slow down its progression. Among These modalities of intra-articular injections the autologous PRP has gained more attention in the treatment of patients with knee osteoarthritis in recent years. Several studies is supporting the use of PRP injection as an effective method for Knee osteoarthritis, as latelet-rich plasma (PRP) could serve as anti-nociceptive and induce cell proliferation. also intra-articular injection of latelet-rich plasma modulates joint environment, promote chondrogenesis and inhibits the destruction of knee joint probably by reducing the production of pro-inflammatory mediators by the supra-physiologic concentrations of biological molecules and growth factors exist in in the granules of the platelets which could potentially reverse the catabolic environment in osteoarthritis, balancing the homeostasis of the joint, and subsequently stimulate the repair of damaged cartilage.

Conditions

• Intra Articular Injection
• Corticosteroids
• Plasma Rich in Growth Factors
• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	Intra-articular Ozone and corticosteroids	patients will undergo one session a week for a total of four sessions of intra-articular knee injection with combination of 5ml (25 μg/ml) ozone injection + 2 ml lignocaine 2% + 2 ml Betamethasone sodium phosphate 4 mg. Under aseptic precautions. A22-gauge needle was positioned inferior-laterally into the infera-patellar pouch, injection of 2 ml of 4 mg Betamethasone sodium phosphate, and 2 ml injection lignocaine 2% was injected slowly (over 1-2 minutes). The needle was left in space for the 5 ml (25 μg/ml) ozone injection. Patients were advised to avoid strenuous activity for 2-3 days following the intra-articular injection.
DRUG	intra-articular PRGF Method	Patients will undergoes two doses with 2 weeks interval by injection of already synthetic plasma rich in growth factors \[PRGF\] vial intra-articularly. This vial is formed of lyophilized cake of platelet growth factors in a tightly sealed container stored at 2-8◦C which synthesized under complete aseptic technique by activation of platelets to release its growth factors and cytokines which help in knee cartilage regeneration and act as potent anti-inflammatory to reduce the pain. Prior to usage, reconstitution of the product was done using 1 ml saline and 1 ml lignocaine 2% followed by gentle vial rubbing for 3 min then, the mixture was kept at ambient temperature for 5 min to ensure complete protein re-hydration.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-05-20
• Completion: 2023-05-20
• First posted: 2023-05-01
• Last updated: 2024-02-20

Locations

2 sites across 1 country: Egypt