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

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03300531
• Other study ID #: 2017.N0.003
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 28, 2017
• Last updated: October 5, 2017
• Start date: December 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2017
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Weiliang Shen, Doctor
• Phone: +86-13757101563
• Email: wlshen[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

All injection will be done under ultrasound guidance.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 540
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendinitis
• Lateral Epicondylitis
• Rotator Cuff Tear
• Tendinopathy
• Tennis Elbow

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Zhejiang Xingyue Biotechnology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks	Pain on activity will be evaluated by VAS	Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Secondary	Constant-Murley Score(CMS)	Functional score of the shoulder	Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Secondary	American Shoulder and Elbow Surgeons (ASES) Shoulder Score	Functional score of the shoulder	Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Secondary	The Disabilities of the Arm, Shoulder and Hand(DASH) Score	Functional score of the shoulder	Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Secondary	Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A)	Functional score of the achilles tendon	Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Secondary	Adverse events	Adverse events to evaluate the safety	From baseline through study completion, an average of 3 year