NCT04165902

Brief Summary

Using double-blind, randomized controlled design to compare the immediate, short-term and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection of hyaluronic acid injection on patients with knee osteoarthritis, under the basis of International Classification of Functioning, Disability, and Health.

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
60

participants targeted

Target at P25-P50 for phase_4 knee-osteoarthritis

Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_4 knee-osteoarthritis

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

First Submitted

Initial submission to the registry

November 10, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

November 11, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

November 10, 2019

Last Update Submit

November 17, 2019

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis, hyaluronic acid, steroid, dextrose

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMaster Universities Osteoarthritis index

    assess knee osteoarthritis related performance

    changes of scores from baseline to at one week, one month, 3 months and 6 months after 3 times of injections; score range: 0-100, higher scores mean a worse outcome

Secondary Outcomes (7)

  • Balance

    changes of scores from baseling to at one week, one month, 3 months and 6 months after 3 times of injections; score range 0-4, higher scores mean a better outcome

  • physical functional performance-walking

    change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections

  • physical functional performance-stairs climbing

    change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections

  • physical functional performance-chair raising

    change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections

  • physical functional performance-balance

    change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections

  • +2 more secondary outcomes

Study Arms (2)

steroid plus hyaluronic acid

EXPERIMENTAL

steroid plus hyaluronic acid injection, one time per week, for 3 weeks

Drug: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis

dextrose plus hyaluronic acid

ACTIVE COMPARATOR

dextrose plus hyaluronic acid injection, one time per week, for 3 weeks

Drug: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis

Interventions

compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritisDRUG

compare the immediate effect (one week after 3 times of injections), short-term effects (one month and three months after 3 times of injections), and midterm effect (6 months after 3 times of injections).

dextrose plus hyaluronic acidsteroid plus hyaluronic acid

Eligibility Criteria

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

You may qualify if:

  • clinical diagnosis of knee osteoarthritis can walk for 15 meters Kellgren-Lawerence grade 2 or greater than 2 can follow up for 6 months

You may not qualify if:

  • major diseases will affect balance, such as stroke, infectious diseases, rheumatoid arthritis, dizziness, or vertigo fractures malignance pregnancy or prepare to pregnant received knee injections in the past 6 months previous operation of knee joints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Ru-Lan Hsieh, MD

    Shin Kong Wu Ho-Su Memorial Hospital

    STUDY CHAIR

Central Study Contacts

Ru-Lan Hsieh, MD

CONTACT

886-2984161201M001052@ms.skh.org.tw

Study Design

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

Study Record Dates

First Submitted

November 10, 2019

First Posted

November 18, 2019

Study Start

November 11, 2019

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

November 19, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)