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

Overview

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 Title of Study: “Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Diseaseļ¼šA Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2020

Detailed Description

All injection will be done under ultrasound guidance.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: P-PRP
    • Blood will be drawn and pure platelet-rich plasma will be injected into the tendon.
  • Experimental: PRP
    • Blood will be drawn and platelet-rich plasma will be injected into the tendon.
  • Active Comparator: Compound betamethasone
    • 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) )

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks
    • Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
    • Pain on activity will be evaluated by VAS

Secondary Measures

  • Constant-Murley Score(CMS)
    • Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
    • Functional score of the shoulder
  • American Shoulder and Elbow Surgeons (ASES) Shoulder Score
    • Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
    • Functional score of the shoulder
  • The Disabilities of the Arm, Shoulder and Hand(DASH) Score
    • Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
    • Functional score of the shoulder
  • Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A)
    • Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
    • Functional score of the achilles tendon
  • Adverse events
    • Time Frame: From baseline through study completion, an average of 3 year
    • Adverse events to evaluate the safety

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Collaborator
    • Zhejiang Xingyue Biotechnology Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Weiliang Shen, Doctor, +86-13757101563, wlshen@zju.edu.cn

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