Homologous PRP vs Placebo in Knee Osteoarthritis in Over 65 Years Old Patients

Study Overview
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Brief Summary
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The aim of the study is to compare the 6 months clinical outcome of the treatment with a single injection of Homologous PRP versus single injection of placebo (saline solution) in the infiltrative treatment of knee osteoarthritis in over 65 years old patients. The evaluation will be performed through clinical, subjective and objective assessments.

Detailed Description
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204 patients affected by knee osteoarthritis will be included in a double-blinded RCT with possibility ,after 6 months, to cross-over from control arm ( saline solution ) to the treatment arm (Homologous PRP). Patients will be followed-up with clinical evaluation at 1,3 and 6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment. Patients in the treatment arm (Homologous PRP) will be followed for an additional 6 months (up to 12 months of follow-up). After 6 months, patients in the control arm have the possibility to cross-over into the treatment arm, in which case they will be followed for an additional 12 months.

Official Title
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Homologous PRP Versus Placebo in the Infiltrative Treatment of Knee Osteoarthritis in Over 65 Years Old Patients.

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Homologous PRP injections
* Procedure: Placebo injection (saline solution)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral involvement; Signs and symptoms of degenerative pathology of the knee cartilage; Radiographic or MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades); Ability and consent of patients to actively participate in clinical follow-up; Signature of informed consent Exclusion Criteria: 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 with metabolic disorders of the thyroid gland; Patients abusing alcoholic beverages, drugs or medications Body Mass Index > 35

Ages Eligible for Study
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Minimum 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: Crossover Assignment
Interventional Model Description: The study is a double-blinded RCT with possibility ,after 6 months, to cross-over from control arm (saline solution ) to the treatment arm (Homologous PRP). After 6 months, patients in the control arm have the possibility to cross-over into the treatment arm, in which case they will be followed for an additional 12 months.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homologous PRP<br>This group of patients will be treated with single intra-articular injection of Homologous PRP. At the 6-month follow-up visit, the patient will be informed about the treatment received. | Procedure: Homologous PRP injections<br>* Patients will be treated with a single injection of Homologous PRP (5 ml) in the knee joint affected by osteoarthritis.<br>|
| Placebo Comparator: Saline solution<br>This group of patients will be treated with single intra-articular injection of saline solution (placebo). At the 6-month follow-up visit, patients will be informed about the treatment received. Patients of this group can cross-over to the treatment arm after 6 months. | Procedure: Placebo injection (saline solution)<br>* Patients will be treated with a single injections of saline solution (5 ml) in the knee joint affected by 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. | 6 months FU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS Score | KOOS SCORE consists of 5 subscales and covers: pain (9 items), symptoms (7 items, two of which are related to stiffness), functions and activities of daily living (17 items), physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items). Each question is scored from 0 to 4, where 0 indicates no difficulty and 4 severe difficulty. Score range 0-100 for each subscale | baseline, 1 month, 3 months, 6 and 12 months follow-up | 
| 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, 1 month, 3 months, 6 and 12 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, 1 month, 3 months, 6 and 12 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, 1 month, 3 months, 6 and 12 months follow-up | 
| EQ-5D (EuroQoL) Current Health Assessment | EQ-5D is useful to evaluate the quality life of the patients | baseline, 1 month, 3 months, 6 and 12 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, 1 month, 3 months, 6 and 12 months follow-up | 
| Objective parameters- Range of Motion | Evaluation of the Range of Motion for comparative analysis. | baseline, 1 month, 3 months, 6 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, 1 month, 3 months, 6 and 12 months follow-up | 
| Objective parameters - Circumferences | Bilateral trans- and supra- patellar circumferences measurement for comparative analysis | baseline, 1 month, 3 months, 6 and 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, knee osteoarthritis, PRP, Homologous PRP, PRP injections, injection treatment, Randomized controlled trial, osteoarthritis