Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Clinical Results Of Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis (KOA), Our Experience At Midterm Follow Up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852380
• Other study ID #: PRP-Knee Osteoarthritis
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: April 1, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 81 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Italy	AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)