Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis

NCT ID: NCT04852380

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 153 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-04-01

Brief Summary

It was conducted a prospective study with a series of 153 patients treated with PRP injections in patient affected by knee osteoarthritis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection).

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Score Society (KSS) score and the Visual Analogue Scale (VAS) were evaluated and recorded for each patient at each follow up.

Conditions

Knee Osteoarthritis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients treated by PRP injection

PRP injections

Intervention Type: PROCEDURE

The 5 mL PRP concentrate was injected every week for three times, starting from recruitment. The patient was placed supine whit a knee flexion of 90°.All the procedures were carried out in an aseptic condition, injected in the knee soft spot through an anterior approach, using a 21-gauge needle.

Interventions

PRP injections

The 5 mL PRP concentrate was injected every week for three times, starting from recruitment. The patient was placed supine whit a knee flexion of 90°.All the procedures were carried out in an aseptic condition, injected in the knee soft spot through an anterior approach, using a 21-gauge needle.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age between 40 and 81;
• Body mass index (BMI) between 21.5 and 29.3;
• Chronic history (for at least 4 months) of knee joint pain;
• Radiographically documented knee osteoarthritis of grades 1 to 3 (Kellgren-Lawrence (K-L) radiographic classification scale)

Exclusion Criteria

• Radiographically severe documented knee osteoarthritis of grade 4 (K-L radiographic classification scale);
• Previous femur and tibia fractures;
• Knee previous surgical treatment (e.g., arthroscopy);
• Hyaluronic acid infiltration within the previous six months;
• Hemoglobin levels <10 g/dL;
• History of oncohematological disease, infections, or immunodepression

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, , Italy

Countries

Italy

Other Identifiers

PRP-Knee Osteoarthritis

Identifier Type: -

Identifier Source: org_study_id