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

NCT03300531 | Unknown Phase 2

• 1 other identifier: 2017.N0.003
• Study Type: interventional
• Target: 540
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rotator Cuff Tear; Lateral Epicondylitis; Achilles Tendinitis

Keywords

Pure Platelet-rich Plasma; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Constant-Murley Score(CMS)

  Baseline, 3 weeks, 6 weeks, 12 weeks after intervention

• American Shoulder and Elbow Surgeons (ASES) Shoulder Score

  Baseline, 3 weeks, 6 weeks, 12 weeks after intervention

• The Disabilities of the Arm, Shoulder and Hand(DASH) Score

  Baseline, 3 weeks, 6 weeks, 12 weeks after intervention

• Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A)

  Baseline, 3 weeks, 6 weeks, 12 weeks after intervention

• Adverse events

  From baseline through study completion, an average of 3 year

Study Arms (3)

P-PRP

EXPERIMENTAL

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

PRP

EXPERIMENTAL

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

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

Compound betamethasone

ACTIVE COMPARATOR

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

Interventions

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

P-PRP

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

PRP

Ultrasound-guided Compound betamethasone injection 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.

Compound betamethasone

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 34590307 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries; Tennis Elbow

Interventions

Injections

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Weiliang Shen, Doctor

CONTACT

+86-13757101563; wlshen@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 3, 2017
• Study Start: December 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: October 9, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share