This is a Phase I/II Randomized Double-Blinded Standard of Care (Corticosteroid) vs. Sterile Amniotic Fluid for Osteoarthritis
This study will look at blinded standard of care (SOC) steroid injection vs. amniotic fluid injection (pAF) to treat and reduce osteoarthritis (OA) inflammation and pain. The main objectives of this study are to establish the safety and tolerability of allogeneic intra-articular pAF injections. Secondary objectives include pain levels and functional outcome scoring in patients over a 12 month time frame.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Comparison of Standard of Care (Corticosteroid) injection vs. Sterile Processed Amniotic Fluid Injection for Knee Osteoarthritis
Comparison of Standard of Care (Corticosteroid) injection vs. Sterile Processed Amniotic Fluid Injection for Knee Osteoarthritis
University of Utah Orthopedic Center
Salt Lake City, Utah, United States
Repeat Allogeneic Intra-articular Injection Within 6 Months.
Participants in both the SOC and pAF treatment arms may require and/or request rescue medication (i.e. SOC injection) at any time and will be given per PI discretion as part of standard of care. The clinicians will not know which study arm the study participant is in but will treat the participant with the SOC injection. This information will be documented and collected in the Electronic Medical Record (EMR), as well as the study's electronic data capture system. Participants will not be given any additional pAF injections throughout the study period. The participant will continue to be treated with SOC injections as needed. The outcome will be an indicator of whether or not a subject received a rescue medication within 6 months.
Time frame: 6 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee Injury and Osteoarthritis Outcome Score (KOOS) \[assessment of joint symptoms, pain, and function on a scale from 0 to 100\]. With higher scores representing better symptoms, pain and function.
Time frame: 6 months
Visual Analog Scale for Pain (VAS Pain)
Pain was assessed using the Visual Analog Scale for pain (VAS), measured on a scale of 0 to 10. With 0 being no pain at all and 10 being the most pain possible.
Time frame: 6 months
Single Assessment Numerical Evaluation (SANE)
Self-reported functional outcomes were evaluated throughout the study period using the Single Assessment Numerical Evaluation (SANE) \[scored as a percentage of normal for the affected joint on a scale from 0-100%\]. With higher values representing higher levels of function.
Time frame: 6 months
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (PF-CAT)
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Self-reported functional outcomes were evaluated using the PROMIS Physical Function Computer Adaptive Test \[self-report of capabilities related to activities of daily living scored from 0 to 100\]. With higher values representing higher levels of function.
Time frame: 6 months