Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis. Double-blind Controlled Randomized Clinical Trial (PRP22-Hip)

NCT05497349 NA RECRUITING

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.

Details

Lead sponsor	Istituto Ortopedico Rizzoli
Phase	NA
Status	RECRUITING
Enrolment	230
Start date	2022-10-05
Completion	2026-10

Conditions

• Hip Osteoarthritis

Interventions

• Leukocyte Rich- PRP injection
• Leukocyte Poor- PRP injection

Primary outcomes

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) — 6 months follow-up
  It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome

Countries

Italy