Rotator Cuff TearPhase 2NCT03300531
Impact of Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease
A Phase 2 study testing Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection, Ultrasound-guided platelet-rich-plasma (PRP) injection and Ultrasound-guided Compound betamethasone injection in people with Rotator Cuff Tear and Lateral Epicondylitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
This is a randomized parallel controlled double-blind phase 2 clinical study.All subjects are recruited from the patients of rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis. Patients will be randomly divided into three groups. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rotator Cuff Tear, Lateral Epicondylitis, Achilles Tendinitis
- What is being tested?
- Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection, Ultrasound-guided platelet-rich-plasma (PRP) injection and Ultrasound-guided Compound betamethasone injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 31 Dec 2021
- Phase
- Phase 2
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinically diagnosed as rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis;
- symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid;
- patient that can understand the clinical trials and signed the informed consent.
Who cannot join
- patient that underwent other injection treatment within 6 weeks
- some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
- patient that enrolled other clinical trials within 3 months
- history of drug/alcohol addiction, habitual smoker
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease：A Randomized Controlled Trial
This is a randomized parallel controlled double-blind phase 2 clinical study.All subjects are recruited from the patients of rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis. Patients will be randomly divided into three groups. Autologous pure platlet-rich plasma (P-PRP) and platlet-rich plasma (PRP) are purified from the peripheral blood .Patients of case groups will receive P-PRP or PRP injection once a week for three times while the control group received the same dose compound betamethasone injection. Follow up visit will occur at 1 month,3 months, 6 months,12 months after the last injection. Clinical quantitative assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.
Read the detailed description
All injection will be done under ultrasound guidance.
- Being tested
- Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection, Ultrasound-guided platelet-rich-plasma (PRP) injection, Ultrasound-guided Compound betamethasone injection
- Keywords
- Pure Platelet-rich Plasma, Randomized Controlled Trial
- Medical subject headings
- Rotator Cuff Injuries, Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided pure platelet-rich-plasma (P-PRP) injectionBiological
Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Pure platelet-rich plasma will be injected into the tendon.Once a week for three times.
Ultrasound-guided platelet-rich-plasma (PRP) injectionBiological
Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Platelet-rich plasma will be injected into the tendon.Once a week for three times.
Ultrasound-guided Compound betamethasone injectionDrug
Tendon will be penetrated with dry needle under ultrasound guidance. Compound betamethasone will be injected into the tendon.Once a week for three times.
| Study group | Role | What they receive |
|---|---|---|
| P-PRP | Experimental | Blood will be drawn and pure platelet-rich plasma will be injected into the tendon. Receives: Biological: Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection |
| PRP | Experimental | Blood will be drawn and platelet-rich plasma will be injected into the tendon. Receives: Biological: Ultrasound-guided platelet-rich-plasma (PRP) injection |
| Compound betamethasone | Active comparator | 1ml dexamethasone mixed with 0.5-2ml of saline to achieve the same injection volume (which contains betamethasone dipropionate 5mg and betamethasone sodium phosphate 2mg) ) Receives: Drug: Ultrasound-guided Compound betamethasone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks
Pain on activity will be evaluated by VAS
Measured: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Secondary outcomes (5)
Constant-Murley Score(CMS)
Functional score of the shoulder
Measured: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Functional score of the shoulder
Measured: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
The Disabilities of the Arm, Shoulder and Hand(DASH) Score
Functional score of the shoulder
Measured: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A)
Functional score of the achilles tendon
Measured: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Adverse events
Adverse events to evaluate the safety
Measured: From baseline through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Dec 2017 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Xingyue Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300531
- Sponsor's protocol ID
- 2017.N0.003
- Status last verified
- Sep 2017
- First submitted
- 28 Sep 2017
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2.
PubMed 34590307
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease：A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03300531
- Acronym / sponsor ID
- 2017.N0.003
- Keywords
- Pure Platelet-rich Plasma, Randomized Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang Xingyue Biotechnology Co., Ltd.
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Oct 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.
This is a randomized parallel controlled double-blind phase 2 clinical study.All subjects are recruited from the patients of rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis. Patients will be randomly divided into three groups. Autologous pure platlet-rich plasma (P-PRP) and platlet-rich plasma (PRP) are purified from the peripheral blood .Patients of case groups will receive P-PRP or PRP injection once a week for three times while the control group received the same dose compound betamethasone injection. Follow up visit will occur at 1 month,3 months, 6 months,12 months after the last injection. Clinical quantitative assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.
Detailed description
All injection will be done under ultrasound guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| P-PRP | Experimental | Biological: Ultrasound-guided pure platelet-rich-plasma (P-PRP) injectionBlood will be drawn and pure platelet-rich plasma will be injected into the tendon. |
| PRP | Experimental | Biological: Ultrasound-guided platelet-rich-plasma (PRP) injectionBlood will be drawn and platelet-rich plasma will be injected into the tendon. |
| Compound betamethasone | Active comparator | Drug: Ultrasound-guided Compound betamethasone injection1ml dexamethasone mixed with 0.5-2ml of saline to achieve the same injection volume (which contains betamethasone dipropionate 5mg and betamethasone sodium phosphate 2mg) ) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinically diagnosed as rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis;
- symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid;
- patient that can understand the clinical trials and signed the informed consent.
Key exclusion criteria (4 listed)
- patient that underwent other injection treatment within 6 weeks
- some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
- patient that enrolled other clinical trials within 3 months
- history of drug/alcohol addiction, habitual smoker
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 |
|---|---|---|
| Ultrasound-guided pure platelet-rich-plasma (P-PRP) injectionBlood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Pure platelet-rich plasma will be injected into the tendon.Once a week for three times. | Biological | P-PRP |
| Ultrasound-guided platelet-rich-plasma (PRP) injectionBlood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Platelet-rich plasma will be injected into the tendon.Once a week for three times. | Biological | PRP |
| Ultrasound-guided Compound betamethasone injectionTendon will be penetrated with dry needle under ultrasound guidance. Compound betamethasone will be injected into the tendon.Once a week for three times. | Drug | Compound betamethasone |
Primary outcome
Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Pain on activity will be evaluated by VAS
5 secondary outcomes
Constant-Murley Score(CMS)
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
The Disabilities of the Arm, Shoulder and Hand(DASH) Score
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A)
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Adverse events
Time frame: From baseline through study completion, an average of 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Derived from this study: PubMed 34590307Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection, Ultrasound-guided platelet-rich-plasma (PRP) injection and Ultrasound-guided Compound betamethasone injection in people with Rotator Cuff Tear and Lateral Epicondylitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 3 inclusion and 4 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 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Weiliang Shen, Doctor (+86-13757101563, wlshen@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks (time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03300531, which also lists 1 linked publication.
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 9 Oct 2017.