A Study Comparing Viscosupplementation and Corticosteroid Injections for Knee Osteoarthritis

LifeMark Health

Status: Unknown

Conditions: Osteoarthritis, Knee

Treatments: Device: Hylan G-F 20 (Synvisc One); Drug: Methylprednisolone (Corticosteroid)

Study type: Interventional

Funder types: Other

Identifiers

NCT01132677

HA-CS-OA1

Details and patient eligibility

About

Do differences exist between patients who receive a single intra-articular injection of corticosteroid versus patients who receive a single intra-articular injection of hyaluronic acid for the treatment of knee osteoarthritis at 1, 3 and 6 weeks, and 3 and 6 months post injection?

Full description

OBJECTIVES

Primary i. To determine if patients' VAS "pain while walking" is different at 6 weeks post-injection in patients who receive a single injection of methylprednisolone acetate (MPA) versus patients who receive a single injection of Hylan G-F 20 (Synvisc One™) for treatment of knee OA.

Secondary i. To determine if differences in VAS "pain while walking" scores exist at 1 and 3 weeks, and 3 and 6 months post injection between MPA and HA patients.

ii. To determine if differences in VAS "pain at rest" scores exist at 1, 3 and 6 weeks and 3 and 6 months post injection between MPA and HA patients.

iii. To determine if differences in VAS "pain with stairs" scores exist at 1, 3 and 6 weeks and 3 and 6 months post injection between MPA and HA patients.

iii. To determine if differences in KOOS questionnaire scores exist at 6 weeks, 3 months and 6 months post injection between MPA and HA patients.

iv. To determine if differences in WOMAC questionnaire scores exist at 6 weeks, 3 months, and 6 months post injection between MPA and HA patients.

v. To determine if differences in adverse events exist at 1, 3 and 6 weeks, and 3, and 6 months post injection between MPA and HA patients.

vi. To track the number of patients who receive additional injections after 3 months following their index injection.

Enrollment: 78 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical

  • 19-75 years of age (inclusive)
  • Symptomatic OA (1 of the following: pain, stiffness, or swelling)
  • Evidence of grade I, II or III OA on radiographic images according to Kellgren-Lawrence grading scale.

Exclusion criteria

• Clinical

  • Previous surgery on either knee (not including a diagnostic arthroscopy arthroscopy or simple partial meniscectomy)
  • Intra-articular treatment within the last 3 months
  • Ipsilateral cruciate or collateral ligament injury within past 3 months, or evidence of ligament laxity
  • Inflamed knee or pronounced effusion
  • Allergy to birds, eggs, avian proteins or known HA or corticosteroid
  • Venous or lymphatic stasis
  • Skin condition in the injection area
  • Evidence of infection in the affected joint
  • History of crystalline arthropathy or inflammatory arthritis
  • Pregnant or nursing
  • Third Party, Medical Legal or Workers' Compensation Board
  • Patient unable to understand English or unable to providing informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

78 participants in 2 patient groups

Hyaluronic Acid (HA) Injection

Active Comparator group

Description:

Patients allocated to the HA group will receive a single IA injection Hylan G-F 20 Synvisc One™ (1 injection of 6cc's). All injections will be administered as outlined on the company label. Aspiration of the knee will not be performed.

Treatment:

Device: Hylan G-F 20 (Synvisc One)

Corticosteroid Injection

Active Comparator group

Description:

Patients allocated to the corticosteroid injection will receive a single IA injection of 80mg of methylprednisolone acetate (1cc of solution) mixed with 5cc's of 1% lidocaine without epinephrine for a total of 6cc's. The injection will be administered as outlined on the company label. Aspiration of the knee will not be performed.

Treatment:

Drug: Methylprednisolone (Corticosteroid)