Impact of Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease
Status:
Not yet recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University