ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Adverse Events
研究概览
简要总结
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 4-6 ml intra-articular (IA) injection of either the output of ACP Max™ (n=30) or 6 ml of Depo-Medrol® (methylprednisolone acetate) (n=15).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This is a double-blind study where subjects and evaluators are blinded to treatment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 major trauma to the target knee within one year.
- •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.
研究组 & 干预措施
ACP Max™
Single 4-6 ml intra-articular (IA) injection of the output of ACP Max™
干预措施: ACP Max™ (Device)
40 mg of methylprednisolone acetate
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.
干预措施: Depo-Medrol® (Device)
结局指标
主要结局
Adverse Events
时间窗: 12 months
Analysis of the frequency and severity of all adverse events for the investigational group at 12 months.
Adverse Events
时间窗: 6 months
A comparison of the frequency and severity of all adverse events between the investigational group and the control group at 6 months.
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert Scale(Day 10, 6 weeks, 3, 6, 9 and 12 Months)
- Medication Usage(Day 10, 6 weeks, 3, 6, 9 and 12 months)