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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hip Osteoarthritis

Intervention / Treatment
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* Other: Leukocyte Rich- PRP injection
* Other: Leukocyte Poor- PRP injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients unable to express consent; 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 with malignant neoplasms; Patients with rheumatic diseases;- Patients with uncontrolled diabetes;-Patients with hematological diseases (coagulopathies); Patients on anticoagulant-antiaggregant therapy that cannot be discontinued for at least 3 days prior to blood collection; Patients with uncontrolled thyroid metabolic disorders; Patients abusing alcoholic beverages, drugs or medications; Body Mass Index > 30; Patients who have taken NSAIDs in the 3 days prior to blood draw; Patients with cardiovascular disease for whom 300 ml blood draw would be contraindicated; Patients with recently performed CBC examination with Hb< 11 g/dl and Platelet values < 150,000 plt/mm3. Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab Pregnant and/or fertile women. Pain intensity less than 4 points or greater than 8 in accordance with the VAS scale. 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. Previous extensive surgery of the reference joint (osteotomy around the hip, open or arthroscopic osteochondroplasty for femoro-acetabular conflict).

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a double-blinded RCT in which one group of patients will be treated with 3 intra-articular injection of Leukocyte Rich-PRP, and one group will be treated with 3 intra-articular injection of Leukocyte Poor- PRP
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leukocyte Rich-PRP Injection<br>Three infiltrations of Leukocyte Rich Platelet Rich Plasma 1 infiltration weekly, for 3 weeks | Other: Leukocyte Rich- PRP injection<br>* Autologous Leukocyte Rich-Platelet Rich Plasma will be injected in the hip joint<br>|
| Active Comparator: Leukocyte Poor- PRP Injection<br>Three infiltrations of Leukocyte Poor-Platelet Rich Plasma 1 infiltration weekly, for 3 weeks. | Other: Leukocyte Poor- PRP injection<br>* Autologous Leukocyte Poor-Platelet Rich Plasma will be injected in the hip joint<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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 | 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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 | baseline, 2 month and 12 months | 
| Visual Analogue Scale (VAS) | VAS is a visual analogue scale consisting of a range scale (10 cm length), the ends of which correspond to no pain and the strongest pain imaginable. | baseline, 2 months, 6 months and 12 months follow-up | 
| Harris Hip Scale (HHS) | This scale was developed for the evaluation of hip surgery outcomes and is intended to assess various hip disabilities and treatment methods in an adult population. The four sections that make up the questionnaire are: pain, function, absence of deformity, and range of motion. The HHS is a measure of dysfunction, so higher is the score, better is the outcome for the individual. The maximum possible score is 100. | baseline, 2 months, 6 months and 12 months follow-up | 
| EQ-5D (EuroQoL) Current Health Assessment | EQ-5D is a standardized measure of health-related quality of life developed by the EuroQol Group to provide a simple generic questionnaire for use in clinical and economic evaluation and population health surveys | baseline, 2 months, 6 months and 12 months follow-up | 
| Patient Acceptable Symptom State (PASS) | A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering yes or no. | baseline, 2 months, 6 months and 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet rich plasma, PRP injection, Leukocyte Rich-PRP, Leukocyte Poor-PRP, Hip-OA, Hip Osteoarthritis, Randomized controlled trial, Injection treatment, PRP, LR-PRP, LP-PRP