NCT05497349

Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis

Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis. Double-blind Controlled Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to compare the efficacy up to 12 months of two different types of PRP (PRP with leukocytes vs PRP depleted of leukocytes) in the echo-guided infiltrative treatment of hip OA by including 230 patients in the study and evaluating them through subjective (using the WOMAC score as the primary outcome) and objective clinical scores.

Detailed description

Platelet-rich plasma (PRP) has recently emerged as an attractive biological approach to address joint degeneration. It has gained increasing attention because of the high concentration of growth factors, cytokines, and bioactive molecules stored in platelet-rich α-granules, which have been shown to participate in joint tissue homeostasis, being involved in both healing processes and immunoregulation and modulation of inflammation. Several preparation methods are available for PRP, which can give products with different compositions and characteristics.The presence of leukocytes is one of the most debated aspects of PRP efficacy, and is used as one of the main discriminators to distinguish different PRPs. Patients with OA of the hip will be included in a randomized controlled, double-blind trial, in which one group of patients will be treated with 3 infiltrations of PRP with leukocytes and one group will be treated instead with 3 infiltrations of PRP without leukocytes. A total of 230 patients will be included and will undergo infiltrative treatment after collecting informed consent for study participation. Patients will be clinically evaluated before the injection procedure and at 2-6-12 months after treatment by the medical staff.

Conditions

• Hip Osteoarthritis

Interventions

Type	Name	Description
OTHER	Leukocyte Rich- PRP injection	Autologous Leukocyte Rich-Platelet Rich Plasma will be injected in the hip joint
OTHER	Leukocyte Poor- PRP injection	Autologous Leukocyte Poor-Platelet Rich Plasma will be injected in the hip joint

Timeline

• Start date: 2022-10-05
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2022-08-11
• Last updated: 2025-09-24

Locations

1 site across 1 country: Italy