Additional Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis

Phase 4

• Conditions: Physical Activity; Functional Performance
• Interventions: Device: Hyaluronic acid; Drug: Triamcinolone

• Registration Number: NCT02949466
• Lead Sponsor: Taipei Medical University

Brief Summary

Using a double-blind, randomized controlled design to investigate the additional therapeutic effects of 3 times of combined triamcinolone and hyaluronic acid injections to 3 times of hyaluronic acid injections to patients with knee osteoarthritis.

Detailed Description

A total of 56 patients will be enrolled and randomized into two groups, including 3 times of triamcinolone combined hyaluronic acid injections group and 3 times of hyaluronic acid injections group.

The triamcinolone combined hyaluronic acid injections group will receive 3 times of triamcinolone combined hyaluronic acid injection per week in three weeks; the hyaluronic acid group will receive hyaluronic acid injection in three weeks.

Physical activities and functional performance will be evaluated at before injection, at after one week, one month, three months, and six months of completion of 3 times of injections.

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-28
• Last Update Submitted: 2016-10-29
• Study First Posted: 2016-10-31
• Last Update Posted: 2016-11-01
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• knee osteoarthritis with Kellgren/Lawrence grade II or III

Exclusion Criteria

• who have neurological deficit, such as stroke who have implant in knee

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hyaluronic acid group	Hyaluronic acid	hyaluronic acid (2cc) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined triamcinolone and hyaluronic acid injections to hyaluronic acid injections
triamcinolone and hyaluronic acid group	Hyaluronic acid	combined triamcinolone (Triamcinolone 10 mg 1cc) and hyaluronic acid (2 cc) injections: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined triamcinolone and hyaluronic acid injections to hyaluronic acid injections
triamcinolone and hyaluronic acid group	Triamcinolone	combined triamcinolone (Triamcinolone 10 mg 1cc) and hyaluronic acid (2 cc) injections: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined triamcinolone and hyaluronic acid injections to hyaluronic acid injections

Primary Outcome Measures

Name	Time	Method
Functional performance assessed with the Western Ontario and McMaster Universities Osteoarthritis Index	changes from baseline to at after one week, one month, three months, and six months of completion of injections	Western Ontario and McMaster Universities Osteoarthritis Index

Secondary Outcome Measures

Name	Time	Method
10 meter walk test	changes from baseline to at after one week, one month, three months, and six months of completion of injections	10 meter walk as fast as possible
5 times rapid chair rising test	changes from baseline to at after one week, one month, three months, and six months of completion of injections	rapid chair rising for 5 times as fast as possible
Quality of life assessed with the Knee Injury and Osteoarthritis Outcome Score	changes from baseline to at after one week, one month, three months, and six months of completion of injections	Knee Injury and Osteoarthritis Outcome Score

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan