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

Sponsor

Thammasat University (Other)

Overall Status

Completed

CT.gov ID

NCT01874574

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: Hylan G-F 20 Drug: Corticosteroid	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Triamcinolone acetonide

Arm

Intervention/Treatment

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 Names:

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

Other Names:

Triamcinolone acetonide