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

NCT06631456 | Completed

• 1 other identifier: 09/07/2024-4460
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; platelet rich plasma; ozone therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain, stiffness and physical function-WOMAC

  From enrollment to the end of treatment at 3rd month

• Quality of life-SF-12

  From enrollment to the end of treatment at 3rd month

Study Arms (2)

PRP group

Patients who received intra-articular PRP due to gonarthrosis

Other: PRP injection

Ozone group

Patients who received intra-articular ozone therapy due to gonarthrosis

Other: Ozone therapy

Interventions

PRP injection OTHER

A total of 3 doses of intra-articular PRP were applied to the symptomatic knees of the patients under ultrasound guidance, once a week.

PRP group

Ozone therapy OTHER

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.

Ozone group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Şişli Hamidiye Etfal Training and Research Hospital, İstanbul

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Banu Kuran, Professor

  Şişli Hamidiye Etfal Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: October 8, 2024
• Study Start: August 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 1, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

TU (1)