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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874574
• Other study ID #: OrthoTU-01
• Status: Completed
• Phase: Phase 4
• First received: September 5, 2012
• Last updated: April 21, 2014
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: April 2014
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
Thailand	Thammasat University Hospital, Thammasat University	Prathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC Score	Change from Baseline in WOMAC score at 6 months	6 months	Yes
Secondary	Visual Analogue Scale(VAS)	Change from Baseline in VAS score at 6 months	6 months	Yes