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Completed

NCT Number: NCT01874574

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

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thammasat University Hospital, Thammasat University

Prathumthani, Changwat Pathum Thani, 12121, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hylan G-F 20

Drug

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 names: Synvisc

Corticosteroid

Drug

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 names: Triamcinolone acetonide

Primary outcomes

  1. WOMAC Score

    Time frame: 6 months

    Change from Baseline in WOMAC score at 6 months

Secondary outcomes

  1. Visual Analogue Scale(VAS)

    Time frame: 6 months

    Change from Baseline in VAS score at 6 months

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee: A Prospective, Double-blind Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2013
Registry last updated
Apr 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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