The PROGRESS IV clinical trial is a double-blind, multicenter,
randomized, controlled trial (RCT) with patients receiving either a
single injection of APS or saline. During the injection visit, all
patients will have a blood draw, from which the APS will be prepared
for injection and for laboratory characterization. After all available
joint fluid is aspirated, and appropriate to randomization group,
approximately 2.5 mL of APS or saline will be injected into the joint.
A blinding sleeve covering the contents of the syringe will be
utilized to mask the group assignment from the patient and the
injecting physician, and needle placement will be verified using
ultrasound. Any adverse events associated with the blood draw and/or
injection procedure will be recorded. All subjects should be
instructed not to exceed the pre-injection level of activity for 14 days.
Efficacy and safety will be assessed at 1, 3, 6, and 12 months
post-injection. An X-Ray and MRI will be obtained at baseline and at
12 months to assess anatomical changes. Upon completion of all 12
month follow-up evaluations, group allocation will be unblinded, and
patients from both groups will be permitted to enter a one month
open-label repeat injection phase if they had no major safety concerns
due to the first injection.