The purpose of this study is to determine the effectiveness and safety of autologous alpha-2 macroglobulin rich plasma (A2MRP) injections in the treatment of knee osteoarthritis (OA).
The overall objective of this study is to test and quantify A2MRP and prepare for a larger randomized clinical trial assessing the efficacy of A2MRP injections in primary and post traumatic knee osteoarthritis (OA) with respect to clinical outcomes and disease progression. The study will also assess safety of A2MRP intraarticular injection in patients with symptomatic knee OA. Patients with symptomatic mild to moderate knee OA (KL 2-3) will be candidates for this study. Baseline data will include physical examination of the knee, clinical assessment of knee pain and function using validated patient reported outcome measures (PROMs), and radiologic exam of the knee will be obtained. All injections will be performed using ultrasound guidance and all patients will followed-up at week 1 week post-injection for acute adverse events (AEs). Each subject will be clinically followed-up for study endpoints using a predetermined protocol. PROs will be collected during the study period pre-procedure, and at 1, 2, and 6 weeks, 3-, 6-, 9- and 12-months post-procedure (Specific PRO's and timepoints noted in sections 6.2-6.7). Subjects will also be asked questions regarding satisfaction with the treatment and whether they would recommend the treatment
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Your blood will be processed into Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) A2MRP in the procedure room with you while you wait. This will take approximately 30 minutes. When this is complete, an ultrasound will be done of your knee to determine the best location for injection into the knee joint. You will undergo an ultrasound guided injection, and the needle guided into the knee joint, and the Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) A2MRP will be injected into the joint space. If there is excessive fluid in your knee, this may be drained before the injection is performed. The needle will be removed, and a band aid will be placed over the injection site.
Mayo Clinic
Rochester, Minnesota, United States
Adverse Events
The number of Adverse Events reported
Time frame: 1 year
Visual Analog Scale (VAS) for Pain
The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.
Time frame: 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Pain interference
The PROMIS-CAT: Pain interference is a 40-item questionnaire assessing pain. Using a scale of 1 = not at all to 5 = very much. Total scores range from 40-200, lower scores indicating lower pain and higher scores indicating greater pain.
Time frame: 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Physical function
The PROMIS-CAT: Physical function is a 165-item questionnaire assessing physical function. Using a scale of 1 = unable to do to 5 = without any difficulty. Total scores range from 165-825, lower scores indicating less physical function and higher scores indicating greater physical function.
Time frame: 1 year
Knee Injury and Osteoarthritis Outcome Score (KOOS):
KOOS is a commonly used questionnaire which focuses on how patients are affected by knee problems in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme knee problems, 100 = no knee problems
Time frame: 1 year
Procedure Recommendation
The number of subjects to answer "yes" to the question "Would you recommend this procedure to someone with a similar condition as your own?"
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Time frame: 1 year