Clinical trial NCT01132677: A Study Comparing Viscosupplementation and Corticosteroid Injections for Knee Osteoarthritis
Official title: A Randomized Clinical Trial Comparing Hyaluronic Acid (Hylan G-F 20) and Corticosteroid (Methylprednisolone Acetate) for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: OA of Knee
Osteoarthritis of Knee
Viscosupplementation and Osteoarthritis
Viscosupplementation and OA
Hyaluronic Acid
Corticosteroid injection versus hyaluronic acid
Synvisc One and Knee OA
viscosupplementation and knee pain
knee Pain from OA
Lead sponsor: LifeMark Health
Sponsor class: OTHER
First posted: 2010-05-28
Enrollment: 78
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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?

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome will be "pain while walking for approximately 30 minutes on a flat surface today" as reported by the patient on a 100mm unmarked VAS (0 = no pain; 100 = worst pain possible).
timeFrame: VAS Form will be given at baseline (prior to injection) and then at 1, 3 and 6 weeks, and 3 and 6 months post injection.
Secondary outcomes:
measure: Pain at rest or with stairs as reported byu the patient on a VAS
timeFrame: Baseline (pre-injection), 1, 3 and 6 weeks, and 3 and 6 months post injection
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: LifeMark Health
state: British Columbia
Study officials:
affiliation: UBC - Department of Family Practice
name: Brad J Monteleone, Physician
role: PRINCIPAL_INVESTIGATOR
References: