Knee Osteoarthritis Clinical Trial
Official title:
A Post-market, Single Blind, Multicenter, Randomized, Controlled Trial of HYMOVIS® Intra-articular Injections in Active Subjects With Knee Osteoarthritis
Knee osteoarthritis (OA) is among the most common causes of musculoskeletal pain and
disability. At present, there is no cure for OA. Therefore, the primary aims of therapy are
to reduce pain, maintain or improve function and mobility, and prevent or slow the
progression of adverse changes to the joint tissues, while keeping potential therapeutic
toxicities to a minimum. Current treatment guidelines begin with non-pharmacologic
modalities, such as patient education, weight loss, and physical therapy. Several
exercise-based therapeutic approaches, such as aerobic exercise programs, range-of-motion
exercises, and muscle-strengthening exercises are recommended and have shown clinical benefit
in randomized, controlled clinical trials. However, non-pharmacologic approaches frequently
provide insufficient pain relief and restoration of function and mobility, and pharmacologic
modalities become necessary. Although simple analgesics such as acetaminophen provide relief
for many OA subjects with mild to moderate pain, alternatives should be considered for
subjects who fail to obtain adequate symptomatic relief with these measures.
This post-market, single blind, multicenter, randomized, controlled clinical study is
designed to enroll a relatively young, active population of subjects with patellofemoral
osteoarthritis (PFOA) and/or tibiofemoral osteoarthritis (TFOA), and to compare responses to
treatment with 2 weekly intra-articular (IA) hyaluronan (HA) injections, with each injection
given 1 week apart, of HYMOVIS combined with a physical exercise program (PEP) to PEP alone.
Because PEP or exercise programs may be considered the first line standard of care in OA knee
pain, particularly in younger, active patients, the hypothesis of the study is that Hymovis
combined with PEP program provides greater relief of pain associated with knee OA in the
enrolled study subjects than with use of PEP alone.
The study provides for subjects randomized to the PEP alone study group to cross over to
HYMOVIS+PEP if improvement has not been achieved by the 3 month follow up visit.
Subjects will be recruited over an 18 month period. The duration of the trial per center will
be approximately 27 months. This includes the enrollment period of 6 months, the follow-up
period at 3 and 6 months and the additional follow-up period for patients who crossed-over;
they will be followed for an additional 6 months following the initial 3month follow-up. The
trial will end when the last subject makes the last visit.
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