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

Effects of Platelet-Rich Plasma and Ozone Therapy on Pain and Quality of Life in Knee Osteoarthritis: A Retrospective Study

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: PRP injection; Other: Ozone therapy

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 Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Şişli Hamidiye Etfal Training and Research Hospital, İstanbul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Stage 2-3 gonarthrosis according to KL who apply to our hospital's Physical Medicine and Rehabilitation out-patient clinic will be included.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PRP group; Patients who received intra-articular PRP due to gonarthrosis	Other: PRP injection; A total of 3 doses of intra-articular PRP were applied to the symptomatic knees of the patients under ultrasound guidance, once a week.
Ozone group; Patients who received intra-articular ozone therapy due to gonarthrosis	Other: Ozone therapy; A total of 3 doses of intra-articular ozone therapy were applied to the symptomatic knees of the patients under ultrasound guidance, once a week.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain, stiffness and physical function-WOMAC	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.	From enrollment to the end of treatment at 3rd month
Quality of life-SF-12	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.	From enrollment to the end of treatment at 3rd month

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Study Director: Banu Kuran, Professor, Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: October 5, 2024
• First Submitted That Met QC Criteria: October 5, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 5, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: knee osteoarthritis; platelet rich plasma; ozone therapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 09/07/2024-4460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No