Knee OsteoarthritisPhase 4NCT05220527
Effects of Knee Injections on Patients With Knee Osteoarthritis
A Phase 4 study testing Triamcinolone plus hyruan, vitagen plus hyruan and normal saline plus hyruan in people with Knee Osteoarthritis and Injection, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Using a double-blind, randomized, placebo-controlled design to compare the immediate, short-term, and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection to 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, Injection, Effect of Drug
- What is being tested?
- Triamcinolone plus hyruan, vitagen plus hyruan and normal saline plus hyruan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 31 Jul 2022
- 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-Lawrence grade 2 or greater
- can follow up for 6 months
Who cannot join
- Major diseases will affect balance, such as stroke
- infectious disease,
- rheumatoid arthritis,
- malignancy
- pregnancy or prepare to pregnant
- received knee injections in the past 6 months
- previous knee operation history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effects of Knee Intra-articular Injections on Patients With Knee Osteoarthritis: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Using a double-blind, randomized, placebo-controlled design to compare the immediate, short-term, and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection to 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 three groups, including the hyaluronic acid combined corticosteroid group, hyaluronic acid combined dextrose group, and hyaluronic acid combined normal saline group (placebo group). The functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score), pain (pressure threshold by pain pressure ergometer), and physical activity (10 meters normal and fast walk, up and downstairs, 5 repeated chair-rising time, timed up and go test) and image progression by high-resolution ultrasound will be evaluated before treatment, one week after injections, one month after injections, three months after injections, and six months after injections.
Participants and evaluators will be both blinded to the group's allocation during the whole course of intervention.
- Conditions
- Knee Osteoarthritis, Injection, Effect of Drug
- Being tested
- Triamcinolone plus hyruan, vitagen plus hyruan, normal saline plus hyruan
- Keywords
- knee osteoarthritis, steroid, hyaluronic acid, 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.
Triamcinolone plus hyruanDrug
Also called corticosteroids plus hyaluronic acid
triamcinolone plus hyruan injections, one time per week, for 3 weeks
vitagen plus hyruanDrug
Also called dextrose plus hyaluronic acid
vitagen plus hyruan injections, one time per week, for 3 weeks
normal saline plus hyruanDrug
Also called normal saline plus hyaluronic acid
normal saline plus hyruan injections, one time per week, for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | triamcinolone plus hyruan injection Receives: Drug: Triamcinolone plus hyruan |
| Experimental | Active comparator | vitagen plus hyruan injection Receives: Drug: vitagen plus hyruan |
| Placebo | Placebo comparator | normal saline plus hyruan injection Receives: Drug: normal saline plus hyruan |
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 related performance, scores: 0-100, higher score indicates a worse outcome
Measured: changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
Secondary outcomes (5)
physical functional performance-walking
10 meters normal and fast walking speed
Measured: changes of time (seconds) 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: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
physical functional performance-chair rising
time for 5 repeated chair-rising time
Measured: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
physical functional performance-balance
time for up and go test
Measured: changes of time (seconds) 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 knee osteoarthritis related function, scores: 0-100, higher score indicates a better outcome
Measured: changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start1 Aug 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (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, Care provider, 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
- Sponsor
- Investigators
- Ru-Lan Hsieh, MD, Study chair, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220527
- Sponsor's protocol ID
- MOST109-2314-B-341-001
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: By request, the data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Knee Intra-articular Injections on Patients With Knee Osteoarthritis: a Double-blind, Randomized, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05220527
- Acronym / sponsor ID
- MOST109-2314-B-341-001
- Conditions
- Knee Osteoarthritis, Injection, Effect of Drug
- Keywords
- knee osteoarthritis, steroid, hyaluronic acid, 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
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 2 Feb 2022 (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 a double-blind, randomized, placebo-controlled design to compare the immediate, short-term, and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection to 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 three groups, including the hyaluronic acid combined corticosteroid group, hyaluronic acid combined dextrose group, and hyaluronic acid combined normal saline group (placebo group). The functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score), pain (pressure threshold by pain pressure ergometer), and physical activity (10 meters normal and fast walk, up and downstairs, 5 repeated chair-rising time, timed up and go test) and image progression by high-resolution ultrasound will be evaluated before treatment, one week after injections, one month after injections, three months after injections, and six months after injections.
Participants and evaluators will be both blinded to the group's allocation during the whole course of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Triamcinolone plus hyruantriamcinolone plus hyruan injection |
| Experimental | Active comparator | Drug: vitagen plus hyruanvitagen plus hyruan injection |
| Placebo | Placebo comparator | Drug: normal saline plus hyruannormal saline plus hyruan injection |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of knee osteoarthritis
- can walk for 15 meters
- Kellgren-Lawrence grade 2 or greater
- can follow up for 6 months
Key exclusion criteria (7 listed)
- Major diseases will affect balance, such as stroke
- infectious disease,
- rheumatoid arthritis,
- malignancy
- pregnancy or prepare to pregnant
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 |
|---|---|---|
| Triamcinolone plus hyruanAlso: corticosteroids plus hyaluronic acidtriamcinolone plus hyruan injections, one time per week, for 3 weeks | Drug | Study group |
| vitagen plus hyruanAlso: dextrose plus hyaluronic acidvitagen plus hyruan injections, one time per week, for 3 weeks | Drug | Experimental |
| normal saline plus hyruanAlso: normal saline plus hyaluronic acidnormal saline plus hyruan injections, one time per week, for 3 weeks | Drug | Placebo |
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
assess knee related performance, scores: 0-100, higher score indicates a worse outcome
5 secondary outcomes
physical functional performance-walking
Time frame: changes of time (seconds) 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: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
physical functional performance-chair rising
Time frame: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
physical functional performance-balance
Time frame: changes of time (seconds) 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: Yes. By request, the data will be shared with other researchers.
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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 Triamcinolone plus hyruan, vitagen plus hyruan and normal saline plus hyruan in people with Knee Osteoarthritis and Injection, 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 4 inclusion and 7 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 2 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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). 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 2 Feb 2022.