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

NCT ID: NCT05837494

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-05-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group ozone

Group Type: ACTIVE_COMPARATOR

Intra-articular Ozone and corticosteroids

Intervention Type: DRUG

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.

Group PRGF(plasma rich in growth factors)

Group Type: ACTIVE_COMPARATOR

intra-articular PRGF Method

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients aged 21-65 years
• both genders
• who will be diagnosed with stage 2-3 knee osteoarthritis according to the Kellgren-Lawrence Classification System (K-L) [10], with WOMAC Score > 2 for pain stiffness and physical disabilities
• having symptoms of Knee OA at least 3 months after getting usual conservative treatment like oral analgesics and Therapeutic Exercises.

Exclusion Criteria

• Patient refusal.
• Patients who will be diagnosed with Stage 1or 4 OA according to K-L Classification
• History of knee trauma within the past month
• History of malignancies
• Any surgical intervention of the knee
• Local or systemic infection
• Any patient with sever renal Impairment
• Bleeding disorders

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hamdy Saied Ayad

Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty Of Medicine Tanta University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Hamdy saied Ayad

Tanta, El-Gharbia, Egypt

Tanta University

Tanta, , Egypt

Countries

Egypt

Other Identifiers

35293/2/22

Identifier Type: -

Identifier Source: org_study_id