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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02949466
Other study ID # MOST 105-2314-B-341-002
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received October 25, 2016
Last updated October 29, 2016
Start date October 2016
Est. completion date July 2017

Study information

Verified date October 2016
Source Taipei Medical University
Contact Ru-Lan Hsieh, MD
Phone 886-2-28332211
Email M001052@ms.skh.org.tw
Is FDA regulated No
Health authority Taiwan: National Science Council
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 56
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 85 Years
Eligibility 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

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


Intervention

Drug:
Triamcinolone
compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis
Device:
Hyaluronic acid
compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis

Locations

Country Name City State
Taiwan Shin Kong Wu Ho-Su Memorial Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional performance assessed with the Western Ontario and McMaster Universities Osteoarthritis Index 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 No
Secondary 10 meter walk test 10 meter walk as fast as possible changes from baseline to at after one week, one month, three months, and six months of completion of injections No
Secondary Quality of life assessed with the Knee Injury and Osteoarthritis Outcome Score 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 No
Secondary 5 times rapid chair rising test rapid chair rising for 5 times as fast as possible changes from baseline to at after one week, one month, three months, and six months of completion of injections No
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