Randomized Evaluation of the Efficacy of Synvisc-One® for the Treatment of Patellofemoral Chondromalacia
Condition: Chondromalacia Patella; Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Cartilage Diseases; Chondromalacia Patellae
Study type: Interventional

Summary: 
      The purpose of this study is to determine how safe a knee injection called Synvisc-One® is in
      patients with a condition called chondromalacia patella and how well in works in treating the
      condition.

      Chondromalacia patella is a common cause of kneecap pain or front knee pain. Often called
      "Runner's Knee," this condition often affects young, otherwise healthy individuals.

      Chondromalacia is due to irritation of the undersurface of the kneecap. The undersurface of
      the kneecap, or patella, is covered with a layer of smooth cartilage. This cartilage normally
      glides effortlessly across the knee during bending of the joint. In some individuals, the
      cartilage on the undersurface of the knee cap becomes irritated and soft, resulting in pain.
      Potential treatments for this condition include rest, injections (numbing or
      anti-inflammatory medications to reduce swelling and pain), and/or guided strengthening
      exercises which may help reduce pain.

      Other Treatments are being evaluated. This study is about Synvisc-One® an experimental device
      that has been approved by the Food and Drug Administration (FDA) for the treatment of pain in
      osteoarthritis (OA) of the knee in patients who have failed to respond to treatments that do
      not involve drugs or surgery and simple pain medication such as acetaminophen. Synvisc-One®
      is a gel-like substance that, when injected into a joint, acts to lubricate and cushion the
      joint. Synvisc-One® is made from hyaluronan, which is a molecule that is found normally in
      joint fluid.

      Synvisc-One® has not been proven to be safe or helpful in patients with chondromalacia
      patella (cartilage irritation or softening of the undersurface of the 'knee cap'). So far,
      this drug/device has been given to over 10,000 people who have knee pain (due to
      osteoarthritis) and has been proven safe and effective in patients with moderate to severe
      pain due to knee joint osteoarthritis.
    

Detailed description: 
      Study Procedures:

      Screening visit:

      After written informed consent is obtained, initial screening will consist of a thorough
      medical history and physical examination and standing, bilateral PA, lateral and merchant
      view x-ray evaluation. Special attention will be given to inclusion and exclusion criteria as
      listed above. Only patients who meet all inclusion and exclusion criteria will be allowed to
      continue to Baseline outcomes data collection and randomization. The following subjective
      outcomes, clinical examination and quadriceps strength data will be collected at each
      session.

      Subjective Outcomes

        -  Knee Injury Outcome and Osteoarthritis Score (KOOS)

        -  Anterior knee pain rating during single-leg squat (10cm visual analog scale-VAS)

      Quadriceps strength testing

      • Maximal, normalized isometric knee extension force (N/kg)

      Randomization:

      Each subject will be randomly assigned in a 1:1 ratio to receive one of the treatments
      (group) described above. Randomization will be done a priori via a random number generator.
      Group assignments will be sealed in an envelope each containing a number from 001-100.
      Randomization envelope #001 will be used for the first subject, #002 for the second and so
      on.

      Blinding:

      Both examiner and patient will be blinded to treatment/ group assignment. During the
      injection procedure, we will block patients' view of the injection with the use of a physical
      screen (pillowcase, blanket, sheet, etc) in order to assure the patient is blinded to
      treatment. Patients will be "un-blinded" after the final study endpoints have been collected
      or if needed due to early withdraw or other medical emergency. To maintain blinding and avoid
      measurement bias, the injecting physician will be different from the investigators performing
      outcomes assessments.

      Medication/ Treatment Restrictions and Monitoring:

        -  Patients will be instructed to refrain from any other intra-articular treatment or
           therapy while enrolled in this study

        -  Patients will be interviewed regarding medication usage (dosage and frequency) at each
           visit.

        -  Patients will be instructed to refrain from using any medicine for pain with the
           exception of OTC Tylenol.

      Standardized Exercise prescription:

      Patients will be prescribed a standardized home-based quadriceps strengthening program.
      Patients will be educated on duration and frequency for exercises and will be provided an
      exercise log that will provide exercise descriptions and reminders as well as a method for
      exercise compliance. Subjects will return exercise books at each visit for compliance
      recording.

      Follow-up visits

        -  1 month following injection: Patients will return at 4 weeks (approx 30±7 days)
           following injection. The following outcomes will be recorded during this visit:

             -  Subjective outcomes

             -  Clinical Evaluation

             -  Quadriceps strength testing

             -  Concomitant medications

             -  Adverse Events

        -  3 months following injection: Patients will return at 12 weeks (approx 91±7 days)
           following injection. The following outcomes will be recorded during this visit:

             -  Subjective outcomes

             -  Clinical Evaluation

             -  Quadriceps strength testing

             -  Concomitant medications

             -  Adverse Events

        -  6 months following injection: Patients will return at 26 weeks (approx 182±14 days)
           following injection. The following outcomes will be recorded during this visit:

             -  Subjective outcomes

             -  Clinical Evaluation

             -  Quadriceps strength testing

             -  Concomitant medications

             -  Adverse Events
    

Intervention name(s): Synvisc-One™; Sham Treatment
Intervention type(s): Device; Other
Intervention description(s): A single 6cc injection of Synvisc-One™ will be utilized in this study.; A single needle stick without arthrocentesis or injection.
Other intervention name(s): Hyaluronan; Hyaluronic Acid
Intervention MeSH terms: Hyaluronic Acid; Hylan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Patellofemoral Chondromalacia; Anterior Knee Pain; Patellofemoral Pain Syndrome; Synvisc-One; Hyaluronic Acid