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Two types of platelet-rich plasma injections for hip osteoarthritis compared

Compares two kinds of PRP injection, with or without leukocytes, in hip osteoarthritis.

Key facts

Who runs it
Istituto Ortopedico Rizzoli
Where
Italy1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis
Status
Recruiting
People taking part
230 people, planned
Started
5 Oct 2022
Planned end
Oct 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Leukocyte Rich- PRP injection
  • Leukocyte Poor- PRP injection
Record updated
24 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with early arthritis (osteoarthritis) in one hip. It compares two types of PRP injection, one with white blood cells and one without.

Age
35 Years to 70 Years
Sex
All sexes
Disease stage
Hip osteoarthritis in one hip only. X-ray Grade 1-2 (Tonnis), or MRI signs even if Grade 0. Pain of 4 to 8 on a 0-10 scale in the past week.
Earlier treatment
No injection of another substance in the hip in the previous 6 months. No lower limb surgery in the previous 12 months. No earlier major surgery of the hip.
Biomarker or test result
Hemoglobin > 11 g/dl and platelet count > 150,000 plt/mm3. Negative tests for HBsAg, HCV Ab and HIV-1-2 Ab.

Main reasons for not taking part

  • Cancer, rheumatic disease, blood clotting disorders or uncontrolled diabetes
  • Blood thinners that cannot be stopped for at least 3 days before blood draw, or NSAIDs in the 3 days before
  • Body Mass Index > 30
  • Pregnant women or women who can become pregnant
  • Other hip problems, such as hip deformity or bone death of the hip head

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • Signs and symptoms of hip OA (pain intensity of at least 4 points and not more than 8 of VAS pain - 0-10 scale in the previous week)
  • Radiographic signs of hip OA (Grade 1-2 according to Tonnis classification) or MRI signs (chondropathy or minimal labrum degeneration without acute lesions) even if Grade 0
  • Unilateral involvement; Hemoglobin > 11 g/dl
  • Platelet count > 150,000 plt/mm3 (Recently performed CBC examination)
  • Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
  • No clinically significant electrocardiographic changes (Recently performed ECG)
  • Ability and consent of patients to actively participate in clinical follow-up;- Signature of informed consent

Who cannot take part

  • Patients undergoing infiltration of other substance in the previous 6 months
  • Patients undergoing lower limb surgery to be treated in the previous 12 months
  • Patients on anticoagulant-antiaggregant therapy that cannot be discontinued for at least 3 days prior to blood collection
  • Patients abusing alcoholic beverages, drugs or medications
  • Patients who have taken NSAIDs in the 3 days prior to blood draw
  • Previous extensive surgery of the reference joint (osteotomy around the hip, open or arthroscopic osteochondroplasty for femoro-acetabular conflict)
  • Patients with malignant neoplasms
  • Patients with rheumatic diseases;- Patients with uncontrolled diabetes;-Patients with hematological diseases (coagulopathies)
  • Patients with uncontrolled thyroid metabolic disorders
  • Patients with cardiovascular disease for whom 300 ml blood draw would be contraindicated
  • Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
  • Patients with other hip pathologies: acetabular protrusion, concentric migration of the femoral head, presence of excessive deformity resulting from acetabular or femoral head dysplasia, collapse deformity, and deformed femoral head sequelae of Perthes disease or osteonecrosis of the femoral head
  • Patients with recently performed CBC examination with Hb< 11 g/dl and Platelet values < 150,000 plt/mm3
  • Patients unable to express consent
  • Body Mass Index > 30
  • Pregnant and/or fertile women
  • Pain intensity less than 4 points or greater than 8 in accordance with the VAS scale

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 35 and 70 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Leukocyte Rich-PRP InjectionTreatment being tested

    Three infiltrations of Leukocyte Rich Platelet Rich Plasma 1 infiltration weekly, for 3 weeks

  • Leukocyte Poor- PRP InjectionExisting treatment, for comparison

    Three infiltrations of Leukocyte Poor-Platelet Rich Plasma 1 infiltration weekly, for 3 weeks.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis. Double-blind Controlled Randomized Clinical Trial
Plain-language title
Two types of platelet-rich plasma injections for hip osteoarthritis comparedGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT05497349, who can take part
Record updated
24 September 2025