drugset / Trial / NCT03300531

Impact of Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease

NCT03300531

RandomizedParallel-groupDouble-blindTreatment

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. 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.

Timeline

Start
2017-12-01
Primary completion
2020-12-31
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator BETAMETHASONE DIPROPIONATE Small molecule 2 mg Other
Comparator BETAMETHASONE DIPROPIONATE Small molecule 5 mg Other
Subject Platelet Rich Plasma Other / unclassified Other
Subject pure platelet-rich plasma Unknown Other