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

Zhejiang University

Status and phase: Unknown; Phase 2

Conditions: Rotator Cuff Tear; Achilles Tendinitis; Lateral Epicondylitis

Treatments: Biological: Ultrasound-guided platelet-rich-plasma (PRP) injection; Biological: Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection; Drug: Ultrasound-guided Compound betamethasone injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03300531

2017.N0.003

Details and patient eligibility

About

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.

Full description

All injection will be done under ultrasound guidance.

Enrollment: 540 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. clinically diagnosed as rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis;
2. symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid;
3. patient that can understand the clinical trials and signed the informed consent.

Exclusion criteria

1. patient that underwent other injection treatment within 6 weeks
2. 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)
3. patient that enrolled other clinical trials within 3 months
4. history of drug/alcohol addiction, habitual smoker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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540 participants in 3 patient groups

P-PRP

Experimental group

Description:

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

Treatment:

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

PRP

Experimental group

Description:

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

Treatment:

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

Compound betamethasone

Active Comparator group

Description:

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) )

Treatment:

Drug: Ultrasound-guided Compound betamethasone injection