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A Study Comparing Viscosupplementation and Corticosteroid Injections for Knee Osteoarthritis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
LifeMark Health
ClinicalTrials.gov Identifier:
NCT01132677
First received: May 27, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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?


Condition Intervention
Osteoarthritis, Knee
 Device: Hylan G-F 20 (Synvisc One)
Drug: Methylprednisolone (Corticosteroid)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Hyaluronic Acid (Hylan G-F 20) and Corticosteroid (Methylprednisolone Acetate) for Knee Osteoarthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by LifeMark Health:

Primary Outcome Measures:
  • 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). [ Time Frame: 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. ] [ Designated as safety issue: No ]
    As described in title


Secondary Outcome Measures:
  • Pain at rest or with stairs as reported byu the patient on a VAS [ Time Frame: Baseline (pre-injection), 1, 3 and 6 weeks, and 3 and 6 months post injection ] [ Designated as safety issue: No ]

    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.)



Estimated Enrollment: 78
Study Start Date: May 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132677

Locations
Canada, British Columbia
LifeMark Health
Kelowna, British Columbia, Canada, V1Y 6G2
Sponsors and Collaborators
LifeMark Health
Investigators
Principal Investigator: Brad J Monteleone, Physician UBC - Department of Family Practice
  More Information

No publications provided

Responsible Party: Dr. Brad Monteleone, LifeMark Health
ClinicalTrials.gov Identifier: NCT01132677     History of Changes
Other Study ID Numbers: HA-CS-OA1
Study First Received: May 27, 2010
Last Updated: May 27, 2010
Health Authority: Canada: Health Canada

Keywords provided by LifeMark Health:
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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 23, 2013