TendinopathyPhase 2/3NCT03986372
The Effect of Multiple Injection of Platlet-rich Plasma in Chronic Patellar Tendinopathy
A Phase 2/3 study testing Platlet-rich plasma in people with Tendinopathy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
According to previous studies, the effect of PRP to patellar tendinopathy could last longer. However, the type, concentration, time and frequent of injection are still debated。 This study is to understand the effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy and to analyze the… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Platlet-rich plasma
- 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
- 20 Aug 2019to Jun 2023
- Phase
- Phase 2/3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic patellar tendinopathy
Who cannot join
- Corticosteroid injections within 12 months
- Previous knee surgery
- Any confounding diagnosis to the knee joint
- Arthritis
- Rheumatoid arthritis
- Diabetes
- Infections of knee joint
- NSAIDs in the 10 days before the procedure
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taoyuan Chang Gung Memorial Hospital
Taoyuan, 333
Chih-Kuan Wu, MD, +886963039829, xavierwu829@gmail.com
About this study
According to previous studies, the effect of PRP to patellar tendinopathy could last longer. However, the type, concentration, time and frequent of injection are still debated。 This study is to understand the effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy and to analyze the relation between efficacy of PRP and the growth factor in PRP.
Read the detailed description
Patellar tendinopathy, also known as jumper's knee，is clinically common characterised by anterior knee pain, activity-related pain、local tenderness over inferior pole of patella. The discomfort can result in decreasing athletic performance and be one of the most challenge for sports medicine doctor.
The patellar tendon suffer from repetitive microtrauma，result in reactive patellar tendinopathy. The overload tendon combining with risk factors of patellar tendinopathy will not recover timely and progress to chronic patellar tendinopathy. Hence, to reverse the progression is our aim.
According to previous studies, several nonsurgical treatment options have been proposed such as medication, eccentric exercise, corticosteroid injection, shockwave and platelet-rich plasma (PRP). Among all the options, the effect of PRP could last longer. However, the type, concentration, time and frequent of injection are still debated。Moreover, there is no study about the relationship between efficacy and the ratio and concentration of growth factor in the PRP.
The aim of this study is to understand (1) The effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy. (2) The effect of leukocyte-rich PRP in chronic patellar tendinopathy (3) Analyze the relation between efficacy of PRP and the growth factor in PRP.
- Conditions
- Tendinopathy
- Being tested
- Platlet-rich plasma
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platlet-rich plasmaBiological
Multiple Platlet-rich plasma injection.
| Study group | Role | What they receive |
|---|---|---|
| PRP injection, once | Experimental | PRP injection, once Receives: Biological: Platlet-rich plasma |
| PRP injection, twice | Experimental | PRP injection, twice, 2 weeks apart Receives: Biological: Platlet-rich plasma |
| PRP injection, 3 times | Experimental | PRP injection, 3 times, 2 weeks apart Receives: Biological: Platlet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Victorian Institute of Sport Assessment (VISA-P) score to 36 weeks
Clinical evaluation for patellar tendinopathy minimum score: 0(worse outcome) maximum score: 100(better outcome)
Measured: 36 weeks
Change from baseline modified Blazina Scale to 36 weeks
Clinical evaluation for patellar tendinopathy Stage 0 - No pain Stage 1 - Pain only after intense sports activity; no undue functional impairment Stage 2 - Pain at the beginning and after sports activity; still able to perform at a satisfactory level Stage 3 - Pain during sports activity; increasing difficulty in performing at a satisfactory level Stage 4 - Pain during sports activity; unable to participate in sport at a satisfactory level Stage 5 - Pain during daily activity; unable to participate in sport at any level
Measured: 36 weeks
Change from baseline thickness of patellar tendon to 36 weeks
Sonographic evaluation for patellar tendinopathy to measure the thickness of proximal patellar tendon.
Measured: 36 weeks
Change from baseline Visual analogue score(VAS) to 36 weeks
evaluation for pain(minimal score:0, maximal score:10)
Measured: 36 weeks
Secondary outcomes (4)
Correlation between Platlet derived growth factor (PDGF) and VISA-P score
Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(PDGF)
Measured: 36 weeks
Correlation between Transforming growth factor beta 1 (TGF beta 1) and VISA-P score
Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(TGF beta 1)
Measured: 36 weeks
Correlation between Epithelial growth factor (EGF) and VISA-P score
Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(EGF)
Measured: 36 weeks
Change from baseline Victorian Institute of Sport Assessment (VISA) score to 104 weeks
To evaluate the longterm effect of multiple PRP injection
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start20 Aug 2019
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986372
- Sponsor's protocol ID
- 201900117A3
- Status last verified
- Aug 2021
- First submitted
- 9 Jun 2019
- Last updated
- 16 Mar 2022
- Results posted
- 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 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multiple Injection of Platlet-rich Plasma in Chronic Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT03986372
- Acronym / sponsor ID
- 201900117A3
- Conditions
- Tendinopathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 14 Jun 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.
According to previous studies, the effect of PRP to patellar tendinopathy could last longer. However, the type, concentration, time and frequent of injection are still debated。 This study is to understand the effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy and to analyze the relation between efficacy of PRP and the growth factor in PRP.
Detailed description
Patellar tendinopathy, also known as jumper's knee，is clinically common characterised by anterior knee pain, activity-related pain、local tenderness over inferior pole of patella. The discomfort can result in decreasing athletic performance and be one of the most challenge for sports medicine doctor.
The patellar tendon suffer from repetitive microtrauma，result in reactive patellar tendinopathy. The overload tendon combining with risk factors of patellar tendinopathy will not recover timely and progress to chronic patellar tendinopathy. Hence, to reverse the progression is our aim.
According to previous studies, several nonsurgical treatment options have been proposed such as medication, eccentric exercise, corticosteroid injection, shockwave and platelet-rich plasma (PRP). Among all the options, the effect of PRP could last longer. However, the type, concentration, time and frequent of injection are still debated。Moreover, there is no study about the relationship between efficacy and the ratio and concentration of growth factor in the PRP.
The aim of this study is to understand (1) The effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy. (2) The effect of leukocyte-rich PRP in chronic patellar tendinopathy (3) Analyze the relation between efficacy of PRP and the growth factor in PRP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRP injection, once | Experimental | Biological: Platlet-rich plasmaPRP injection, once |
| PRP injection, twice | Experimental | Biological: Platlet-rich plasmaPRP injection, twice, 2 weeks apart |
| PRP injection, 3 times | Experimental | Biological: Platlet-rich plasmaPRP injection, 3 times, 2 weeks apart |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic patellar tendinopathy
Key exclusion criteria (8 listed)
- Corticosteroid injections within 12 months
- Previous knee surgery
- Any confounding diagnosis to the knee joint
- Arthritis
- Rheumatoid arthritis
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 |
|---|---|---|
| Platlet-rich plasmaMultiple Platlet-rich plasma injection. | Biological | PRP injection, 3 times, PRP injection, once, PRP injection, twice |
Primary outcome
Change from baseline Victorian Institute of Sport Assessment (VISA-P) score to 36 weeks
Time frame: 36 weeks
Clinical evaluation for patellar tendinopathy minimum score: 0(worse outcome) maximum score: 100(better outcome)
Change from baseline modified Blazina Scale to 36 weeks
Time frame: 36 weeks
Clinical evaluation for patellar tendinopathy Stage 0 - No pain Stage 1 - Pain only after intense sports activity; no undue functional impairment Stage 2 - Pain at the beginning and after sports activity; still able to perform at a satisfactory level Stage 3 - Pain during sports activity; increasing difficulty in performing at a satisfactory level Stage 4 - Pain during sports activity; unable to participate in sport at a satisfactory level Stage 5 - Pain during daily activity; unable to participate in sport at any level
Change from baseline thickness of patellar tendon to 36 weeks
Time frame: 36 weeks
Sonographic evaluation for patellar tendinopathy to measure the thickness of proximal patellar tendon.
Change from baseline Visual analogue score(VAS) to 36 weeks
Time frame: 36 weeks
evaluation for pain(minimal score:0, maximal score:10)
4 secondary outcomes
Correlation between Platlet derived growth factor (PDGF) and VISA-P score
Time frame: 36 weeks
Correlation between Transforming growth factor beta 1 (TGF beta 1) and VISA-P score
Time frame: 36 weeks
Correlation between Epithelial growth factor (EGF) and VISA-P score
Time frame: 36 weeks
Change from baseline Victorian Institute of Sport Assessment (VISA) score to 104 weeks
Time frame: 104 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Platlet-rich plasma in people with Tendinopathy, run by Chang Gung Memorial Hospital 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 8 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 16 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Chih-Kuan Wu, MD (+886963039829, xavierwu829@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Victorian Institute of Sport Assessment (VISA-P) score to 36 weeks (time frame: 36 weeks). The study lists 4 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 16 Mar 2022.