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

May 27, 2010
May 27, 2010
May 2010
May 2011   (final data collection date for primary outcome 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). [ 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
Same as current
No Changes Posted
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.)

Same as current
Not Provided
Not Provided
 
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?

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Osteoarthritis, Knee
  • Device: Hylan G-F 20 (Synvisc One)
    Single IA injection of 6cc's. Injections will be administered as outlined on the company label.
  • 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.
  • 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.
    Intervention: Device: Hylan G-F 20 (Synvisc One)
  • 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.
    Intervention: Drug: Methylprednisolone (Corticosteroid)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
78
December 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
19 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01132677
HA-CS-OA1
No
Dr. Brad Monteleone, LifeMark Health
LifeMark Health
Not Provided
Principal Investigator: Brad J Monteleone, Physician UBC - Department of Family Practice
LifeMark Health
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP