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

NCT01874574 | Completed Phase 4 DMC

• 1 other identifier: OrthoTU-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Corticosteroid; Hyaluronic acid; Intra-articular injection

Outcome Measures

Primary Outcomes (1)

• WOMAC Score

  Change from Baseline in WOMAC score at 6 months

  6 months

Secondary Outcomes (1)

• Visual Analogue Scale(VAS)

  6 months

Study Arms (2)

Single shot Hylan G-F 20 (Synvisc)

EXPERIMENTAL

Intra-articular injection of the Single shot 6 mL of Hylan G-F 20 (Synvisc)

Drug: Hylan G-F 20

Corticosteroid (Triamcinolone acetonide)

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Synvisc

Single shot Hylan G-F 20 (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.

Also known as: Triamcinolone acetonide

Corticosteroid (Triamcinolone acetonide)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Thammasat University Hospital, Thammasat University

Prathumthani, Changwat Pathum Thani, 12121, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

hylan; Adrenal Cortex Hormones; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Nattapol Tammachote, MD, MSc

  Department of Orthopaedics, Thammasat University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Phonthakorn Panichkul

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: June 11, 2013
• Study Start: January 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 22, 2014

Record last verified: 2014-04

Locations

TH (1)