Synvisc-One for Younger, Active Patients With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This study aims to study use of viscosupplementation as a treatment of pain for young
      individuals who are active. Typically viscosupplementation is considered an intervention for
      knee osteoarthritis often for older patients who are less active. Many young active patients
      can also develop knee osteoarthritis after trauma or surgery or for congenital reasons.
      Treatment of these patients commonly are steroid injections which have more biologically
      detrimental effects for cartilage compared to viscosupplementation Synvisc One injections
      which are a single injection will be used to determine effectiveness of reducing pain and
      maintaining an active healthy lifestyle for younger patients aged 30-50 years old.
    

Detailed description: 
      This study will be an open label longitudinal cohort study with natural history over 3 years.
      Screening data will be reviewed to determine subject eligibility. Subjects who meet all
      inclusion criteria and none of the exclusion criteria will be entered into the study.
      Subjects enrolled in the cohort will have baseline functional testing performed including a
      motion gait analysis, 12 minute walk test, and 3-day accelerometer data. Subjects will
      receive a single 6 mL intra-articular injection of hylan G-F 20 in the target knee at
      baseline. All ongoing treatments will be monitored at 6 month intervals over the 3 year
      duration of the study. Patients can receive any other conservative treatments (e.g., oral
      medications, physical or other therapy, acupuncture, etc., except other injection treatments)
      and current treatments will be documented during each patient encounter. An initial injection
      of hylan G-F 20 will be injected in the symptomatic knee using a standard supine lateral
      approach using a 20 gauge needle. A face to face follow up visit will be carried out 6 months
      after first injection with additional face to face meetings every 6 months thereafter unless
      the subject requires an additional injection of hylan G-F 20. Hylan G-F 20 treatments can be
      administered up to three times each year during the study duration. After each injection,
      follow up measures will be carried out using secure e-mail or phone contact at 6 weeks, 12
      weeks, 18 weeks after each in-office evaluation or injection. Follow up will consist of
      WOMAC, Lysholm score, and Tegner score. Patients may return for retreatment of hylan G-F 20
      if symptoms recur after at least 4 months following their previous injection and they meet
      the inclusion criteria with pain levels of WOMAC A1, C8, C9, C10 and/or C23 equaling 2 or
      more. Patients requiring three injections of hylan G-F 20 in 4 months or less will be allowed
      to exit the cohort after their six-month follow up following the third injection. Otherwise,
      patients will be followed until they reach the 3 year follow up, or drop out for other
      injection treatments or surgical treatment. Therefore, patients would potentially be able to
      receive up to 9 injections during the 3 year study.
    

Intervention name(s): Synvisc-One (G-F 20)
Intervention type(s): Device
Intervention description(s): Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.
Intervention MeSH terms: Hylan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osteoarthritis; viscosupplementation; Active; Knee; Synvisc-One