Status:
UNKNOWN
Impact of Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Zhejiang Xingyue Biotechnology Co., Ltd.
Conditions:
Rotator Cuff Tear
Lateral Epicondylitis
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief 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. Pa...
Detailed Description
All injection will be done under ultrasound guidance.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT03300531
Start Date
December 1 2017
End Date
December 31 2021
Last Update
October 9 2017
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