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

This study is currently recruiting participants.
Verified June 2013 by Thammasat University
Sponsor:
Information provided by (Responsible Party):
Phonthakorn Panichkul, Thammasat University
ClinicalTrials.gov Identifier:
NCT01874574
First received: September 5, 2012
Last updated: June 6, 2013
Last verified: June 2013
  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


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: September 2013
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01874574

Locations
Thailand
Thammasat University Hospital, Thammasat University Recruiting
Prathumthani, Thailand, 12121
Contact: Nattapol Tammachote, MD, MSc       tammachotemd@gmail.com   
Principal Investigator: Phonthakorn Panichkul, MD         
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: June 6, 2013
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
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 April 16, 2014