NCT02949466

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

October 25, 2016

Last Update Submit

October 29, 2016

Conditions

Physical ActivityFunctional Performance

Keywords

knee osteoarthritistriamcinolonetherapeutic effects

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 10 meter walk test

    changes from baseline to at after one week, one month, three months, and six months of completion of injections

  • 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

  • 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

Study Arms (2)

triamcinolone and hyaluronic acid group

EXPERIMENTAL

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

Drug: TriamcinoloneDevice: Hyaluronic acid

hyaluronic acid group

ACTIVE COMPARATOR

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

Device: Hyaluronic acid

Interventions

TriamcinoloneDRUG

compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis

Also known as: corticosteroids
triamcinolone and hyaluronic acid group
Hyaluronic acidDEVICE

compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis

hyaluronic acid grouptriamcinolone and hyaluronic acid group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • knee osteoarthritis with Kellgren/Lawrence grade II or III

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

Location

Related Publications (1)

  • Wang CP, Lee WC, Hsieh RL. Effects of Repeated Co-Injections of Corticosteroids and Hyaluronic Acid on Knee Osteoarthritis: A Prospective, Double-Blind Randomized Controlled Trial. Am J Med. 2022 May;135(5):641-649. doi: 10.1016/j.amjmed.2021.11.016. Epub 2021 Dec 24.

    PMID: 34958762DERIVED

MeSH Terms

Conditions

Motor ActivityOsteoarthritis, Knee

Interventions

TriamcinoloneAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

BehaviorOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Ru-Lan Hsieh, MD

    Shin Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru-Lan Hsieh, MD

CONTACT

886-2-28332211M001052@ms.skh.org.tw

Ru-Lan Hsieh, MD

CONTACT

886-2-28332211rulan@tmu.edu.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 31, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

November 1, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)