Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis

NCT04852380 | Completed

• 1 other identifier: PRP-Knee Osteoarthritis
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

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

Keywords

knee osteoarthritis (KOA); Platelet-rich plasma (PRP);

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analogic Scale

  The knee pain was quantified using the Visual Analogic Scale ranging from 0 (no pain) to 10 (worst imaginable pain).

  Day 0; Month 1; Month 3; Month 6 (after the injection)

Study Arms (1)

Patients treated by PRP injection

Procedure: PRP injections

Interventions

PRP injections 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.

Patients treated by PRP injection

Eligibility Criteria

• Age: 40 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

One hundred and fiftythree patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between January 2018 and January 2020 with knee osteoarthritis

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Study Sites (1)

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 21, 2021
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: April 1, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

IT (1)