Knee OsteoarthritisPhase 4NCT04165902
Additional Effects of Steroid and Dextrose to Hyaluronic Acid on Knee Osteoarthritis
A Phase 4 study testing compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis in people with Knee Osteoarthritis, run by Taipei Medical University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Nov 2019to 31 Jul 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of knee osteoarthritis can walk for 15 meters Kellgren-Lawerence grade 2 or greater than 2 can follow up for 6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additional Therapeutic Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis: a Double-blind, Randomized-controlled Clinical Trial
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.
Read the detailed description
A total of 60 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid combined corticosteroid group and hyaluronic acid combined dextrose group. The balance, physical activity (10 meters normal and fast walk, up and downstairs, and 5 repeated chair-rising time, timed up and go test), functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score) will be evaluated. All the evaluations will be re-evaluated at one week after injection, one month after injection, three months after injection, and six months after injection. Subjects and evaluators will be both blinded to the group's classification during the whole course of study.
- Conditions
- Knee Osteoarthritis
- Being tested
- compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis
- Keywords
- knee osteoarthritis, hyaluronic acid, steroid, dextrose
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| steroid plus hyaluronic acid | Experimental | steroid plus hyaluronic acid injection, one time per week, for 3 weeks Receives: 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 Receives: Drug: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis index
assess knee osteoarthritis related performance
Measured: 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
Berg Balance scale
Measured: 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
10 meters normal and fast walking speed
Measured: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
physical functional performance-stairs climbing
time for up and down stairs
Measured: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
physical functional performance-chair raising
5 repeated chair-rising time
Measured: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
physical functional performance-balance
timed up and go test
Measured: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
Knee Injury and Osteoarthritis Outcome Score
assess osteoarthritis of knee related function
Measured: 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 at better outcome
Doppler resistance index
assess knee blood vessel resistance
Measured: changes of scores from baseline to at one week after 1 time of injection and two weeks after 2 times of injection; the lower values indicate a low blood vessel resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start11 Nov 2019 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Hsieh, MD, Study chair, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165902
- Sponsor's protocol ID
- MOST 108-2314-B-341-003
- Status last verified
- Nov 2019
- First submitted
- 10 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Therapeutic Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis: a Double-blind, Randomized-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04165902
- Acronym / sponsor ID
- MOST 108-2314-B-341-003
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, hyaluronic acid, steroid, dextrose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Study start
- 11 Nov 2019 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of 60 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid combined corticosteroid group and hyaluronic acid combined dextrose group. The balance, physical activity (10 meters normal and fast walk, up and downstairs, and 5 repeated chair-rising time, timed up and go test), functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score) will be evaluated. All the evaluations will be re-evaluated at one week after injection, one month after injection, three months after injection, and six months after injection. Subjects and evaluators will be both blinded to the group's classification during the whole course of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| steroid plus hyaluronic acid | Experimental | Drug: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritissteroid plus hyaluronic acid injection, one time per week, for 3 weeks |
| dextrose plus hyaluronic acid | Active comparator | Drug: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritisdextrose plus hyaluronic acid injection, one time per week, for 3 weeks |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of knee osteoarthritis can walk for 15 meters Kellgren-Lawerence grade 2 or greater than 2 can follow up for 6 months
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritiscompare 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). | Drug | dextrose plus hyaluronic acid, steroid plus hyaluronic acid |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis index
Time frame: 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
assess knee osteoarthritis related performance
7 secondary outcomes
Balance
Time frame: 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
Time frame: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
physical functional performance-stairs climbing
Time frame: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
physical functional performance-chair raising
Time frame: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
physical functional performance-balance
Time frame: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
Knee Injury and Osteoarthritis Outcome Score
Time frame: 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 at better outcome
Doppler resistance index
Time frame: changes of scores from baseline to at one week after 1 time of injection and two weeks after 2 times of injection; the lower values indicate a low blood vessel resistance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ru-Lan Hsieh, MD study chair
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis in people with Knee Osteoarthritis, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru-Lan Hsieh, MD (886-2984161201, M001052@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis index (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.