Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Phonthakorn Panichkul, Thammasat University
ClinicalTrials.gov Identifier:
NCT01874574
First received: September 5, 2012
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients.


Condition Intervention Phase
Knee Osteoarthritis
Drug: Hylan G-F 20
Drug: Corticosteroid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee: A Prospective, Double-blind Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Thammasat University:

Primary Outcome Measures:
  • WOMAC Score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Change from Baseline in WOMAC score at 6 months


Secondary Outcome Measures:
  • Visual Analogue Scale(VAS) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Change from Baseline in VAS score at 6 months


Enrollment: 100
Study Start Date: January 2011
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single shot Hylan G-F 20 (Synvisc)
Intra-articular injection of the Single shot 6 mL of Hylan G-F 20 (Synvisc)
Drug: Hylan G-F 20
After full aseptic preparation, Single shot intra-articular injection either 6 mL of Hylan G-F 20 or 1 mL of 40 mg triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline were injected into the joint cavity using the infero-lateral approach via a 21-gauge needle.
Other Name: Synvisc
Active Comparator: Corticosteroid (Triamcinolone acetonide)
Intra-articular injection of 1 mL of 40 mg Triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline injected at the knee by single shot
Drug: Corticosteroid
After full aseptic preparation, Single shot intra-articular injection either 6 mL of Hylan G-F 20 or 1 mL of 40 mg triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline were injected into the joint cavity using the infero-lateral approach via a 21-gauge needle.
Other Name: Triamcinolone acetonide

Detailed Description:

Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients up to 6 months.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of knee OA
  • Knee pain for most days of the prior month
  • Radiographic evidence consistent with knee OA
  • Aged between 40 and 80 years old

Exclusion Criteria:

  • Lumbar spondylosis
  • Gross deformity of the knee
  • Co-existent inflammatory or crystal arthritis
  • Prior knee surgery
  • Injury to the knee in the preceding 6 months
  • Any intra-articular injection in the preceding 3 months
  • Pregnant or Lactating
  • Current infection in the affected knee
  • Inability to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874574

Locations
Thailand
Thammasat University Hospital, Thammasat University
Prathumthani, Thailand, 12121
Sponsors and Collaborators
Thammasat University
Investigators
Study Director: Nattapol Tammachote, MD, MSc Department of Orthopaedics, Thammasat University
  More Information

No publications provided

Responsible Party: Phonthakorn Panichkul, Dr. Phonthakorn Panichkul, Thammasat University
ClinicalTrials.gov Identifier: NCT01874574     History of Changes
Other Study ID Numbers: OrthoTU-01
Study First Received: September 5, 2012
Last Updated: April 21, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by Thammasat University:
Knee Osteoarthritis
Corticosteroid
Hyaluronic acid
Intra-articular injection

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone diacetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents
Anti-Inflammatory Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014