2 Weekly Intra-articular Hyaluronan Knee Injections, Given 1 wk. Apart, of HYMOVIS Combined With Physical Exercise Program (PEP) Compared to PEP Alone, in Relatively Young, Active Population of Subjects With Patellofemoral Osteoarthritis (PFOA) and/or Tibiofemoral Osteoarthritis (TFOA)
Condition: Osteoarthritis, Knee; Knee Osteoarthritis; Patellofemoral Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): HYMOVIS plus Physical Exercise Program (PEP); Physical Exercise Program (PEP) alone
Intervention type(s): Device; Other
Intervention description(s): 1 injection of intra-articular (IA) hyaluronan (HA), Hymovis 24mg/3ml, injection per week for 2 weeks combined with at least 8 weeks of Physical Exercise Program (PEP); Physical Exercise Program (PEP) alone for at least 8 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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 HYMOVIS injections combined with a physical exercise program (PEP) to 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 a 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.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoarthritis; knee osteoarthritis; patellofemoral osteoarthritis; tibiofemoral osteoarthritis; hyaluronan; hyaluronic acid; intra-articular; arthritis; joint disease; active; viscosupplements; Hymovis