A Study Comparing Viscosupplementation and Corticosteroid Injections for Knee Osteoarthritis

A Randomized Clinical Trial Comparing Hyaluronic Acid (Hylan G-F 20) and Corticosteroid (Methylprednisolone Acetate) for Knee Osteoarthritis

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?

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Hylan G-F 20 (Synvisc One); Drug: Methylprednisolone (Corticosteroid)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 6G2
      • LifeMark Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hyaluronic Acid (HA) Injection; 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.	Device: Hylan G-F 20 (Synvisc One); Single IA injection of 6cc's. Injections will be administered as outlined on the company label.
Active Comparator: Corticosteroid Injection; 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.	Drug: Methylprednisolone (Corticosteroid); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	As described in title	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at rest or with stairs as reported byu the patient on a VAS	Secondary Outcomes: i. "Pain at rest" and "pain with stairs" as reported by the patient on a VAS (Additional outcomes ii. Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS is a valid, reliable and responsive questionnaire that is self-administered and consists of 5 subscales. iii. The KOOS includes the WOMAC Osteoarthritis Index LK 3.0 and thus, WOMAC scores will also be computed. iv. Adverse events as reviewed and documented by the physician v. The number of subsequent re-injections or treatment strategies.)	Baseline (pre-injection), 1, 3 and 6 weeks, and 3 and 6 months post injection

Collaborators and Investigators

• Sponsor: LifeMark Health
• Investigators: Principal Investigator: Brad J Monteleone, Physician, UBC - Department of Family Practice

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): May 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: May 27, 2010
• First Submitted That Met QC Criteria: May 27, 2010
• First Posted (Estimate): May 28, 2010

Study Record Updates

• Last Update Posted (Estimate): May 28, 2010
• Last Update Submitted That Met QC Criteria: May 27, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Hyaluronic Acid; Osteoarthritis of Knee; OA of Knee; Viscosupplementation and Osteoarthritis; Viscosupplementation and OA; Corticosteroid injection versus hyaluronic acid; Synvisc One and Knee OA; viscosupplementation and knee pain; knee Pain from OA
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Viscosupplements; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Hylan
• Other Study ID Numbers: HA-CS-OA1