PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT

Study Overview
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Brief Summary
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The aim of the study is to compare the 12-month clinical outcomes of patients with patellofemoral osteoarthritis undergoing infiltrative treatment with fresh PRP and HA

Detailed Description
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166 patients affected by patellofemoral osteoarthritis will be included in a double-blinded RCT. In this study one group of patients will be treated with 1 intra-articular injection of PRP (treatment arm) and one group will be treated with 1 intra-articular injection of HA (control arm). Patients will be followed-up with clinical evaluation at baseline and at 2.6.12 and 24 months. Questionnaires will be administered for clinical evaluations during the follow-up visits.

Official Title
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THE USE OF FRESH PRP VS HA IN THE TREATMENT OF OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT Randomized Controlled Clinical Trial

Conditions
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Patellofemoral Osteoarthritis

Intervention / Treatment
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* Procedure: Autologous PRP injection
* Procedure: HA injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 30 and 65; Signs and symptoms of isolated patellofemoral osteoarthritis present in one or both knees; Radiographic signs of isolated patellofemoral osteoarthritis (according to Iwano et al stage 1-3 classification) or chondropathy (assessed on MRI) with K-L grade of the other compartments ≤ 2. [PMID: 2302884 - PMID: 27979409] ; Hemoglobin > 11 g/dl; Platelet count > 150,000 plt/mm3 (Recently performed CBC exam); No clinically significant electrocardiographic alterations (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 who have undergone intra-articular infiltration of another substance within the previous 6 months; Patients undergoing knee surgery within the previous 12 months; Patients with malignant neoplasms; Patients with rheumatic diseases; Patients with diabetes; Patients with hematologic diseases (coagulopathies); Patients on anticoagulant-antiaggregant therapy; Patients with thyroid metabolic disorders; Patients abusing alcoholic beverages, drugs or medications; Body Mass Index > 35; Patients who have taken NSAIDs in the 3 days prior to blood draw; Patients with cardiovascular disease for which a 60 mL blood draw would be contraindicated; Patients with a recently performed blood test with Hb< 11 g/dl and Platelets < 150,000 plt/mm3. Previous treatment of patellar dislocation Iwano score of grade 4.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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 1 intra-articular injection of fresh PRP, and one group will be treated with 1 intra-articular injection of HA.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous PRP injection<br>This group of patients will be treated with single intra-articular injection of Autologous PRP. | Procedure: Autologous PRP injection<br>* Patients will be treated with a single injection of Autologous PRP (5 ml) in the knee joint affected by patellofemoral osteoarthritis<br>|
| Active Comparator: HA injection<br>This group of patients will be treated with single intra-articular injection of Hyaluronic Acid (HA) | Procedure: HA injection<br>* Patients will be treated with a single injections of Hyaluronic Acid (5 ml) in the knee joint affected by patellofemoral osteoarthritis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS-Pain Score | KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates no pain and 4 severe level of pain. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKDC-Subjective Score | This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function. | baseline, 2 month, 6 months, 12 months , 24 months follow-up | 
| KOOS-Pain Score | KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates no pain and 4 severe level of pain. | baseline, 2 month, 6 months , 24 months follow-up | 
| 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 month, 6 months, 12 months , 24 months follow-up | 
| EQ-VAS | EQ-VAS Is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition). | baseline, 2 month, 6 months, 12 months , 24 months follow-up | 
| EQ-5D (EuroQoL) Current Health Assessment | EQ-5D is useful to evaluate the quality life of the patients | baseline, 2 month, 6 months, 12 months , 24 months follow-up | 
| Tegner Activity Level Scale | Tegner activity level scale allows to know the level of physical activity carried out by the patients. All patients will indicate the type of sporting activity performed and its frequency. | baseline, 2 month, 6 months, 12 months , 24 months follow-up | 
| Objective parameters- Range of Motion | Evaluation of the Range of Motion for comparative analysis. | baseline, 2 month, 6 months, 12 months , 24 months follow-up | 
| Objective parameters - Circumferences | Bilateral trans- and supra- patellar circumferences measurement for comparative analysis | baseline, 2 month, 6 months, 12 months , 24 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 month, 6 months, 12 months , 24 months follow-up | 
| The Kujala Anterior Knee Pain Scale (AKPS) | It's a 100-point scale consisting of 13 items with a score ranging from 5 to 10 points per item. A score of 0 points indicates the most severe limitation, while a score of 100 points indicates a normal situation. | baseline, 2 month, 6 months, 12 months , 24 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRP, HA, Osteoarthritis, Autologous PRP, PRP injection, HA injection, injection treatment, Randomized controlled trial, Hyaluronic Acid, Platelet rich plasma