ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, multicenter (up to 4 sites), randomized, double-blind, two-arm study. Forty-five (45) patients will be randomized to receive a single 6 ml intra-articular (IA) injection of either the output of ACP Max™ (n=30) or Depo-Medrol® (methylprednisolone acetate) (n=15).

Detailed Description
-----------------
All subjects will have a screening visit and a treatment visit followed by six follow-up visits: 10 days, 6 weeks, 3 months, 6 months, 9 months, and 12 months.

Official Title
-----------------
ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial

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

Intervention / Treatment
-----------------
* Device: ACP Max™
* Device: Depo-Medrol®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject voluntarily decides to participate and signs the consent form. Subject is ≥ 18 to 75 years of age. Subject presents with symptomatic knee OA despite at least 6 months of one of the following conservative treatments; oral medications, analgesics, and/or anti-inflammatory medications. Subject has documented radiographic evidence of OA in the tibiofemoral or patellofemoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 12 weeks of screening. Subject has a WOMAC pain score (WOMAC A) of at least 8 out of 20 and at least moderate degree of difficulty (a score of 2) for at least 2 questions on performing daily activities. Subject consents to a washout period of NSAIDs and analgesics 7 days before each study visit (except low-dose aspirin for prevention of cardiovascular disease). Subject has a Body Mass Index ≤ 35 kg/m2 Exclusion Criteria: Subject has Grade I or IV in the target knee according to the Kellgren-Lawrence grading scale. Subject has clinically 3+ effusion of the target knee (stroke test grading system). Subject has significant (> 10°) valgus or varus deformities as evidenced by standard of care x-ray. Subject has received an IA injection of corticosteroids in the target knee within 4 months prior to screening. Subject did not achieve initial pain relief from prior corticosteroid injections. Subject has received an IA injection of HA in the target knee within 6 months prior to screening. Subject has received an IA injection of PRP in the target knee at any time prior to screening. Subject has a history of coagulopathy. Subject has joint pain reflected by a VAS score of > 35 mm out of 100 mm scale in the contralateral knee at the time of screening. Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months. Subject has an inflammatory disease of either knee other than OA. Subject which, in the investigator's opinion, has an underlying medical condition(s) that could interfere with the evaluation of the outcome. Subject with a positive pregnancy test or breastfeeding. Subject plans to participate in other clinical trials involving medical or surgical intervention in the next 12 months. Subject with any condition (including cognitive impairment) that, in the investigator's opinion, might interfere with the evaluation of the study objectives. Subject has rheumatoid arthritis or gout. Subject has an infection at the affected joint. Subject has a history of trauma to the target knee. Subject with plans to undergo any elective orthopedic surgery in the next 12 months. Subject requires pain management therapy not related to the target knee (with the exception of acetaminophen). Subject has a known hypersensitivity to Depo-Medrol and its constituents.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACP Max™<br>Single 4-6 ml intra-articular (IA) injection of the output of ACP Max™ | Device: ACP Max™<br>* Single 4-6 ml intra-articular (IA) injection of the output of ACP Max™<br>|
| Active Comparator: 40 mg of methylprednisolone acetate<br>Single IA injection of 40 mg of methylprednisolone acetate (1 ml of solution) mixed with 5 ml of Normal Saline for a total of 6 ml. | Device: Depo-Medrol®<br>* Single IA injection of 40 mg of methylprednisolone acetate (1 ml of solution) mixed with 5 ml of Normal Saline for a total of 6 ml.<br>* Other names: methylprednisolone acetate);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | A comparison of the frequency and severity of all adverse events between the investigational group and the control group at 6 months. | 6 months | 
| Adverse Events | Analysis of the frequency and severity of all adverse events for the investigational group at 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert Scale | A 24-item questionnaire with 3 subscales measuring pain, stiffness, function and total scores. | Day 10, 6 weeks, 3, 6, 9 and 12 Months | 
| Medication Usage | Medication Usage related to knee pain. | Day 10, 6 weeks, 3, 6, 9 and 12 months |