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

NCT ID: NCT03300531

Last Updated: 2017-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2021-12-31

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. 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.

Detailed Description

All injection will be done under ultrasound guidance.

Conditions

Rotator Cuff Tear; Lateral Epicondylitis; Achilles Tendinitis

Keywords

Pure Platelet-rich Plasma; Randomized Controlled Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

P-PRP

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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.

PRP

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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.

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) )

Group Type: ACTIVE_COMPARATOR

Ultrasound-guided Compound betamethasone injection

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Xingyue Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Weiliang Shen, Doctor

Role: CONTACT

Phone: +86-13757101563

Email: wlshen@zju.edu.cn

References

Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2.

Reference Type: DERIVED

PMID: 34590307 (View on PubMed)

Other Identifiers

2017.N0.003

Identifier Type: -

Identifier Source: org_study_id