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Completed

NCT Number: NCT04852380

Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–81 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, 70124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Visual Analogic Scale

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

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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 21, 2021
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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