Trial | NCT03300531  Report issue

Title

Impact of Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease
Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease：A Randomized Controlled Trial

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    540
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.
All injection will be done under ultrasound guidance.
Study Started
Dec 01
2017
Anticipated
Primary Completion
Dec 31
2020
Anticipated
Study Completion
Dec 31
2021
Anticipated
Last Update
Oct 09
2017

Biological Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection

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.

Biological Ultrasound-guided platelet-rich-plasma (PRP) injection

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.

Drug Ultrasound-guided Compound betamethasone injection

Tendon will be penetrated with dry needle under ultrasound guidance. Compound betamethasone will be injected into the tendon.Once a week for three times.

P-PRP Experimental

Blood will be drawn and pure platelet-rich plasma will be injected into the tendon.

PRP Experimental

Blood will be drawn and platelet-rich plasma will be injected into the tendon.

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) )

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted