Effects of Platelet-Rich Plasma and Ozone Therapy in Knee Osteoarthritis

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: PRP injection; Other: Ozone therapy

• Registration Number: NCT06631456
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Brief Summary

Knee osteoarthritis can frequently occur with advancing age. In cases of pain that persists despite hot/cold applications, drug therapy and exercise, intra-articular injections are considered. In advanced-stage gonarthrosis, steroid injections may respond. However, in mild and moderate knee arthritis, regenerative methods come to the forefront because the joint cartilage is still partially/completely intact. PRP and ozone therapy are frequently applied intra-articular treatments. This study will compare the effects of both injection methods on clinical outcomes.

Detailed Description

Knee osteoarthritis is a common arthrosis that can be encountered frequently with increasing life expectancy. In mild-moderate stages, hot/cold applications, drug treatments and exercise applications are usually applied, while in those who do not respond, physical therapy or intra-articular injection treatments are applied. This retrospective study aims to examine the effects of intra-articular Platelet Rich Plasma (PRP) and ozone therapy on pain, functionality and quality of life in patients with Stage 2-3 gonarthrosis according to the Kelgren-Lawrence (KL) Classification.

Study Timeline

• Study Start: 2024-08-01
• Primary Completion: 2024-09-30
• Status Verified: 2024-10
• Study Completion: 2024-10-01
• Study First Submitted: 2024-10-05
• Study First Submitted QC: 2024-10-05
• Last Update Submitted: 2024-10-05
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• 30-70 years old, Stage 2-3 gonarthrosis according to KL
• Voluntariness to participate in the study

Exclusion Criteria

• Cognitive dysfunction
• General medical condition is not suitable for injections and evaluations
• History of knee injections in the last 3 months
• History of previous knee surgery
• Bleeding disorders or those taking medications that may cause bleeding disorders after injections

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PRP group	PRP injection	Patients who received intra-articular PRP due to gonarthrosis
Ozone group	Ozone therapy	Patients who received intra-articular ozone therapy due to gonarthrosis

Primary Outcome Measures

Name	Time	Method
Pain-Numerical Rating Scale	From enrollment to the end of treatment at 3rd month	Pain level will be evaluated with the Numerical Rating Scale. (minimum: 0, maximum: 10)

Secondary Outcome Measures

Name	Time	Method
Pain, stiffness and physical function-WOMAC	From enrollment to the end of treatment at 3rd month	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each sub-scale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three sub-scales gives a total WOMAC score.
Quality of life-SF-12	From enrollment to the end of treatment at 3rd month	The 12-item short-form health survey (SF-12) quality of life scale was used to evaluate general quality of life. It was presented as a physical component score (PCS) and mental component score (MCS). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

Trial Locations

Locations (1)

Şişli Hamidiye Etfal Training and Research Hospital, İstanbul; 🇹🇷 Istanbul, Turkey