Actively Recruiting
Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis
Led by Istituto Ortopedico Rizzoli · Updated on 2025-09-24
230
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signs and symptoms of hip osteoarthritis with pain intensity between 4 and 8 on a 0-10 scale in the previous week
- Radiographic signs of hip osteoarthritis Grade 1-2 (Tonnis classification) or MRI signs of chondropathy or minimal labrum degeneration
- Unilateral hip involvement
- Hemoglobin level greater than 11 g/dl
- Platelet count greater than 150,000 plt/mm3 from recent blood tests
- Negative serological tests for HBsAg, HCV antibodies, and HIV-1-2 antibodies
- No clinically significant electrocardiographic changes from recent ECG
- Ability and willingness to participate actively in clinical follow-up
- Signed informed consent
You will not qualify if you...
- Unable to give consent
- Received hip joint infiltrations with other substances in the previous 6 months
- Underwent lower limb surgery in the previous 12 months
- Presence of malignant tumors
- Rheumatic diseases
- Uncontrolled diabetes
- Hematological diseases such as coagulopathies
- Taking anticoagulant or antiaggregant therapy that cannot be stopped for at least 3 days before blood collection
- Uncontrolled thyroid metabolic disorders
- Abuse of alcohol, drugs, or medications
- Body Mass Index over 30
- Took NSAIDs within 3 days before blood draw
- Cardiovascular disease contraindicating 300 ml blood draw
- Recent blood tests showing hemoglobin less than 11 g/dl or platelet count less than 150,000 plt/mm3
- Positive for HBsAg, HCV antibodies, or HIV-1-2 antibodies
- Pregnant or fertile women
- Pain intensity less than 4 or greater than 8 on the VAS scale
- Other hip pathologies such as acetabular protrusion, femoral head deformities, or sequelae of Perthes disease or osteonecrosis
- Previous extensive hip surgery like osteotomy or osteochondroplasty
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
Research Team
D
Dante Dallari, MD
CONTACT
R
Roberta Licciardi, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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