Effectiveness Trial for Evaluating IAHA for PFPS
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine the safety and effectiveness of intra-articular
      hyaluronan (IAHA) injections for the treatment of symptomatic patellofemoral pain syndrome
      (PFPS) and determine if this treatment can provide incremental clinical benefits over
      standard care for patients with this diagnosis.
    

Detailed description: 
      Objective: To determine the safety and effectiveness of intra-articular hyaluronan (IAHA)
      injections for the treatment of symptomatic patellofemoral pain syndrome (PFPS) and determine
      if this treatment can provide incremental clinical benefits over standard care for patients
      with this diagnosis.

      Study Design: Two-arm, single-center, parallel, pragmatic, randomized, non-blinded,
      effectiveness trial

      Indication for Use: For treatment of adult patients with Patellofemoral Pain Syndrome (PFPS)
      who have failed to respond to conservative treatment and simple analgesics (e.g.
      acetaminophen).

      Setting: University Teaching Hospital, Faculty Practice

      Subjects: Male and female patients aged 18-40 diagnosed with symptomatic patellofemoral pain
      syndrome (PFPS) that meet all inclusion and exclusion criteria. Approximately 68 subjects
      will be enrolled based on a power analysis of sample size estimation.

      Methods: Patients signing informed consent will be randomized to one of two groups: (1)
      Standard Care, (2) Standard Care plus Intra-articular hyaluronan (IAHA) administered as a
      course of 3 consecutive weekly intra-articular injections.

      Standard Care is defined as consisting of physical therapy, activity modification (relative
      rest), and/or oral analgesic therapy. Upon entering the trial, a specific physical therapy
      (PT) protocol will be implemented.

      Data will be captured on the study knee history and symptoms. Radiographic examinations will
      be performed including weight-bearing anterior-posterior views with knees flexed 30 degrees,
      lateral, and sunrise views. The diagnosis of PFPS will be based on the subjects' being less
      than 40 years of age, and the occurrence of chronic retropatellar pain in the absence of
      other pain-causing abnormalities.

      Arthrocentesis will be performed before all intra-articular injections, and any synovial
      fluid collected will be visually inspected for signs of infection before performing any
      injections. The volume of synovial fluid will be measured, and the samples will then be
      retained for further biomarker analysis.

      A follow-up visit will be scheduled approximately 3 months after the baseline visit, to
      reevaluate patient condition.

      Study Duration: A period of approximately 15 months is anticipated from the time the first
      patient is enrolled to the completion of the last patient visit. A final study report will
      then be generated after this 18 month time point.
    

Intervention name(s): Intra-Articular Hyaluronic Acid-Euflexxa
Intervention type(s): Device
Intervention description(s): IAHA was approved by the FDA in 1997 as a synovial fluid replacement device to help relieve the pain associated with knee osteoarthritis (OA) in patients who fail to respond adequately to conservative treatment and simple analgesics. In this study, IAHA, specifically Euflexxa, will be used off-label to determine whether patients afflicted with PFPS will experience similar analgesic effects as seen in those with OA.
Other intervention name(s): Intra-articular Hyaluronan; IAHA; Viscosupplementation
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patellofemoral; Hyaluronan; Intra-articular; Hyaluronic acid