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

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.

Study Overview

• Status: Unknown
• Conditions: Rotator Cuff Tear; Lateral Epicondylitis; Achilles Tendinitis
• Intervention / Treatment: Biological: Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection; Biological: Ultrasound-guided platelet-rich-plasma (PRP) injection; Drug: Ultrasound-guided Compound betamethasone injection

Detailed Description

All injection will be done under ultrasound guidance.

• Study Type: Interventional
• Enrollment (Anticipated): 540
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Weiliang Shen, Doctor; Phone Number: +86-13757101563; Email: wlshen@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: P-PRP; Blood will be drawn and pure platelet-rich plasma will be injected into the tendon.	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.
Experimental: PRP; Blood will be drawn and platelet-rich plasma will be injected into the tendon.	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.
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) )	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Zhejiang Xingyue Biotechnology Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Pure Platelet-rich Plasma
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Arm Injuries; Elbow Tendinopathy; Rotator Cuff Injuries; Tendinopathy; Tennis Elbow; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone
• Other Study ID Numbers: 2017.N0.003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No