Synovitis of KneeNCT03167333
The Role of Synovitis in Osteoarthritis
A study testing platelet rich plasma and Hyaluronic acid in people with Synovitis of Knee and Osteoarthritis, Knee, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
To determine whether platelet-rich-plasma (PRP) or HA (hyaluronic acid)injection into synovitis in osteoarthritis(OA) knee can achieve improvement in knee function and reduce synovitis. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Synovitis of Knee, Osteoarthritis, Knee
- What is being tested?
- platelet rich plasma and Hyaluronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2020to 1 Mar 2020
- Phase
- Interventional
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with OA knee according to ACR guideline
- stiffness less than 30min
- cracking sound during activity
- more than 30min pain for last 2 months
- non-bed ridden patients
- no structure abnormality
- synovitis was proved by US
Who cannot join
- 1. OA knee secondary to other disease 2 . more than 10 years after diagnosing OA 3. under knee surgery within 3 months 4. autoimmune disease 5. refuses inform/consent process
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei veteran general hospital yuli branch
Hualien City, 886
Chien-Chih Wang, 886 958738258, candycandywang@gmail.com
About this study
Official title: Does Synovitis Affect Treatment Efficacy in Intra-articular Injection Therapy to Osteoarthritis
To determine whether platelet-rich-plasma (PRP) or HA (hyaluronic acid)injection into synovitis in osteoarthritis(OA) knee can achieve improvement in knee function and reduce synovitis.
Read the detailed description
Methods:
sixty patients with OA knee having unilateral or bilateral synovitis validated by ultrasound (N=40) were studied. All the patients were randomized to receive PRP (N=40) or Hyaluronic acid(HA)(N=40) injection twice at 2-week intervals; Clinical assessments were performed using a visual analog scale(VAS) and The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index) before injection at baseline, 4 weeks(first evaluation) and 12 weeks(secondary evaluation). Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.
- Conditions
- Synovitis of Knee, Osteoarthritis, Knee
- Being tested
- platelet rich plasma, Hyaluronic acid
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasmaDrug
The amount of PPR was about 4-5 cc
Hyaluronic acidDrug
HA was 2.5cc
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | the patients received PRP(platelet-rich-plasma) injection twice at 2-week intervals Receives: Drug: platelet rich plasma |
| HA group | Active comparator | the patients received HA(hyaluronic acid) injection twice at 2-week intervals Receives: Drug: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale(VAS)
Measured: before injection at baseline
visual analog scale(VAS)
Measured: 4 weeks(first evaluation)
visual analog scale(VAS)
Measured: 12 weeks(secondary evaluation)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
Measured: before injection at baseline
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
Measured: 4 weeks(first evaluation)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
Measured: 12 weeks(secondary evaluation)
Secondary outcomes (3)
Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.
Measured: before injection at baseline
Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed
Measured: 4 weeks(first evaluation)
Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed
Measured: 12 weeks(secondary evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Synovitis of KneeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167333
- Sponsor's protocol ID
- 2017-03-009B
- Status last verified
- Feb 2020
- First submitted
- 18 May 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Synovitis Affect Treatment Efficacy in Intra-articular Injection Therapy to Osteoarthritis
- ClinicalTrials.gov ID
- NCT03167333
- Acronym / sponsor ID
- 2017-03-009B
- Conditions
- Synovitis of Knee, Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 25 May 2017 (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.
To determine whether platelet-rich-plasma (PRP) or HA (hyaluronic acid)injection into synovitis in osteoarthritis(OA) knee can achieve improvement in knee function and reduce synovitis.
Detailed description
Methods:
sixty patients with OA knee having unilateral or bilateral synovitis validated by ultrasound (N=40) were studied. All the patients were randomized to receive PRP (N=40) or Hyaluronic acid(HA)(N=40) injection twice at 2-week intervals; Clinical assessments were performed using a visual analog scale(VAS) and The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index) before injection at baseline, 4 weeks(first evaluation) and 12 weeks(secondary evaluation). Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Drug: platelet rich plasmathe patients received PRP(platelet-rich-plasma) injection twice at 2-week intervals |
| HA group | Active comparator | Drug: Hyaluronic acidthe patients received HA(hyaluronic acid) injection twice at 2-week intervals |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diagnosed with OA knee according to ACR guideline
Key exclusion criteria (1 listed)
- 1. OA knee secondary to other disease 2 . more than 10 years after diagnosing OA 3. under knee surgery within 3 months 4. autoimmune disease 5. refuses inform/consent process
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 |
|---|---|---|
| platelet rich plasmaThe amount of PPR was about 4-5 cc | Drug | PRP group |
| Hyaluronic acidHA was 2.5cc | Drug | HA group |
Primary outcome
visual analog scale(VAS)
Time frame: before injection at baseline
visual analog scale(VAS)
Time frame: 4 weeks(first evaluation)
visual analog scale(VAS)
Time frame: 12 weeks(secondary evaluation)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
Time frame: before injection at baseline
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
Time frame: 4 weeks(first evaluation)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
Time frame: 12 weeks(secondary evaluation)
3 secondary outcomes
Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.
Time frame: before injection at baseline
Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed
Time frame: 4 weeks(first evaluation)
Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed
Time frame: 12 weeks(secondary evaluation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich plasma and Hyaluronic acid in people with Synovitis of Knee and Osteoarthritis, Knee, run by Taipei Veterans General Hospital, Taiwan 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 7 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 11 Feb 2020. 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.
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 Chien-CHIh Wang, MD (886-958738258, candycandywang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale(VAS) (time frame: before injection at baseline). The study lists 6 primary outcomes in all. 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 11 Feb 2020.