A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip

Inclusion Criteria:

- The patient has symptomatic OA in the target joint

- The patient has had a diagnosis of primary OA of the hip at Screening according to
the American College of Rheumatology (ACR) Criteria

- The patient, if female and of childbearing potential, must have a negative pregnancy
test and have taken oral contraceptives for at least 1 month prior to treatment and
continue for the duration of the study (up to and including the final study visit),
or agree to use 2 forms of contraception (e.g., condoms plus spermatocide), otherwise
females must be surgically sterile, or postmenopausal for at least 1 year

Exclusion Criteria:

- The patient has symptomatic OA in the contralateral hip with a WOMAC A1 NRS score of
≥ 4 at Screening (symptomatic OA with a WOMAC A1 NRS score of 0-3 in the
contralateral hip is allowed)

- The patient if a woman is pregnant, lactating, or unwilling to use adequate
contraception

- The patient had prior viscosupplementation therapy in the target hip joint within 26
weeks of Screening

- The patient has a known history of hypersensitivity to avian protein or any
components of hyaluronan-based injection devices

- The patient has a known history of hypersensitivity to steroids, lidocaine, and/or
acetaminophen

- The patient has a known history of hypersensitivity to injected contrast agent at a
previous radiological examination (e.g., computed tomography [CT] scan, angiogram,
etc.), or known history of hypersensitivity to shellfish or iodine, or any other
impediment to the hip injection procedure

- The patient has active infection in the area of the injection site

- The patient has any major surgery, arthroplasty or arthroscopy in the target hip or
lower extremities within 26 weeks of Screening, or planned surgery in the lower
extremities throughout the duration of the study infectious complications

- The patient used an investigational drug, device or biologic within 12 weeks of
Screening

- The patient has any significant medical condition that the Investigator feels would
interfere with study evaluations and study participation