NCT03238183

Brief Summary

Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and hyaluronic acid combined dextrose injection 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
106

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2017

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

July 28, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

July 28, 2017

Last Update Submit

August 2, 2017

Conditions

Physical ActivityFunctional Disturbance

Keywords

knee osteoarthritishyaluronic aciddextrosetherapeutic effects

Outcome Measures

Primary Outcomes (3)

  • physical activity-on level walking time

    10 meter walking

    changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection

  • physical activity-stair climbing time

    stairs climbing

    changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection

  • physical activity-chair rising time

    chair rising

    changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection

Secondary Outcomes (2)

  • functional performance

    changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection

  • quality of life

    changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection

Study Arms (2)

hyaluronic acid combined dextrose group

ACTIVE COMPARATOR

Hyaluronic acid (2 cc) combined 25% dextrose (3.5 cc 50% dextrose plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections

Drug: dextroseDevice: hyaluronic acid

hyaluronic acid group

PLACEBO COMPARATOR

Hyaluronic acid (2 cc) combined normal saline (3.5 cc normal saline plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections

Device: hyaluronic acid

Interventions

dextroseDRUG

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

Also known as: glucose water
hyaluronic acid combined dextrose group
hyaluronic acidDEVICE

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

hyaluronic acid combined dextrose grouphyaluronic 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)

  • Hsieh RL, Lee WC. Effects of Intra-articular Coinjections of Hyaluronic Acid and Hypertonic Dextrose on Knee Osteoarthritis: A Prospective, Randomized, Double-Blind Trial. Arch Phys Med Rehabil. 2022 Aug;103(8):1505-1514. doi: 10.1016/j.apmr.2022.04.001. Epub 2022 Apr 16.

    PMID: 35439521DERIVED

MeSH Terms

Conditions

Motor ActivityOsteoarthritis, Knee

Interventions

Glucose

Condition Hierarchy (Ancestors)

BehaviorOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Ru-Lan Hsieh

    Shin Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru-Lan Hsieh

CONTACT

228332211M001052@ms.skh.org.tw

Ru-Lan Hsieh

CONTACT

228332211rulan@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
Professor

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 3, 2017

Study Start

August 1, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

August 3, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)