Comparing Efficacy of PRP Combined With Different Hyaluronan for the Treatment of Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Either PRP or HA is each effective for treating knee OA. However, the efficacy of combined PRP and HA injections remains unknown clinically.

Detailed Description
-----------------
Intraarticular plasma-rich platelet (PRP) or hyaluronic acid (HA) was each effective for knee osteoarthritis(OA). The efficacy of combined injections remains unknown. This study aimed to evaluate the efficacy of PRP combined with different hyaluronan for treating knee OA. In a prospective, randomized-controlled trial, 95 patients with Kellgren-Lawrence grade 2 knee OA were randomized to receive a single intraarticular Artz (10mg/ml) followed by PRP (N=48) into target knee or single HYAJOINT Plus (20mg/ml) injection followed by PRP (N=47). Primary outcome was the change from baseline in the visual analog scale (VAS) pain at 6 months. Secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, single leg stance test (SLS), use of rescue analgesics and patient satisfaction.

Official Title
-----------------
Comparing Efficacy of Platelet-rich Plasma (PRP) Combined With Different Hyaluronan for the Treatment of Knee Osteoarthritis: a Randomized Control Trial

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Combination Product: PRP+Artz group
* Combination Product: PRP+ HYAJOINT Plus group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 20-85 years Symptomatic knee osteoarthritis for more than 6 months despite analgesics, NSAIDs, or physical therapy Kellgren-Lawrence grade-2 knee osteoarthritis seen on radiographs made within previous 6 months Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm. Exclusion Criteria: Previous orthopedic surgery on spine or lower limb Disabling osteoarthritis of either hip or foot Knee instability, apparent joint effusion, or marked valgus/varus deformity Known allergy to avian proteins or hyaluronan products Confirmed or suspected pregnancy, or lactating Intra-articular injections into knee in previous 6 months Any specific medical conditions (rheumatoid arthritis, active infection, hemiparesis, neoplasm, hematological etc.) that would interfere with assessments

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The purpose of this study was to compare the efficacy of a single Artz injection followed by PRP with a single HYAJOINT Plus injection followed by PRP in the management of knee OA.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the PRP+Artz group<br>The patients in the PRP+Artz group received one intraarticular Artz injection (2.5 ml) followed consecutively by one intraarticular injection of PRP (3ml). | Combination Product: PRP+Artz group<br>* The patients in the PRP+Artz group received one intraarticular Artz injection (2.5 ml) followed consecutively by one intraarticular injection of PRP (3ml).<br>Combination Product: PRP+ HYAJOINT Plus group<br>* The patients in the PRP+HYAJOINT Plus group received one intraarticular HYAJOINT Plus injection (3ml) followed by one intraarticular injection of PRP (3ml).<br>|
| Experimental: the PRP+HYAJOINT Plus group<br>The patients in the PRP+HYAJOINT Plus group received one intraarticular HYAJOINT Plus injection (3ml) followed by one intraarticular injection of PRP (3ml). | Combination Product: PRP+Artz group<br>* The patients in the PRP+Artz group received one intraarticular Artz injection (2.5 ml) followed consecutively by one intraarticular injection of PRP (3ml).<br>Combination Product: PRP+ HYAJOINT Plus group<br>* The patients in the PRP+HYAJOINT Plus group received one intraarticular HYAJOINT Plus injection (3ml) followed by one intraarticular injection of PRP (3ml).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale (VAS) pain change | the change from baseline in the visual analog scale (VAS) pain score at 6 months. The patient rated the average severity of knee pain on knee movement over the previous week on a 0-100 mm VAS (0 = no pain to 100 = worst possible pain) | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale), t | (WOMAC, Likert Scale) is a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and higher scores indicate worse outcomes. | Month 6 | 
| the Lequesne index | Lequesne index was used to assess severity of knee symptoms during the last week. It includes the measurement of pain, walking distance, and activities of daily living. Maximal score is 24 and higher scores represent worse function. | Month 6 | 
| single-leg stance test (SLS) | Single-leg stance test (SLS) is done by raising one foot up without touching it to the supported lower extremity with target knee and maintain balance for as long as possible. Each participant performed 3 trials, and the best result of the 3 trials was recorded. | Month 6 | 
| patient satisfaction. | Patients were asked to rate their treatment satisfaction compared to the preinjection condition, using a 100 mm VAS (0= completely dissatisfied, 100=completely satisfied). | Month 6 | 
| consumption of analgesics | Acetaminophen (500mg; maximum daily dose, 4 g) was the only rescue medication allowed for knee pain during the study period, Use of rescue medication during the study period was recorded in a patient diary. | Month 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelet-rich plasma, Hyaluronic acid, Knee, Osteoarthritis