A Study Comparing Viscosupplementation and Corticosteroid Injections for Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01132677
• Other study ID #: HA-CS-OA1
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 27, 2010
• Last updated: May 27, 2010
• Start date: May 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2010
• Source: LifeMark Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 78
• Est. completion date: December 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Canada	LifeMark Health	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
LifeMark Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No