Effect of PRP vs Corticosteroid in Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair

NCT ID: NCT05603468

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 387 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-24
• Study Completion Date: 2025-12-31

Brief Summary

Prospective, multicenter, randomized, single-blinded, parallel group，placebo-controlled，three-group establishment of specific treatment regimen for subtypes of tendinopathy

Detailed Description

This clinical trial uses machine learning to match molecular and clinical features，so as to establish a "rapid recognition system of tendinopathy subtypes" and compares the clinical effects of corticosteroid，platelet rich plasma or placebo on different subtypes of tendinopathy.

Conditions

Tendinopathy

Study Design

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

Study Groups

Platelet Rich Plasma group

patients rejected with platelet rich plasma

Group Type: EXPERIMENTAL

platelet rich plasma

Intervention Type: DRUG

Platelet rich plasma group: after the surgery of rotator arthroscopic rotator cuff repair, 3ml PRP (LongTai Biological Company) was injected into the rotator cuff tear under the rotator arthroscope for a time. PRP production process: before anesthesia, 20ml arterial blood was drawn and injected into the PRP tube. The blood was fully oscillated in the tube, and then placed in a centrifuge with 1500g for 9min to remove excess plasma and make 5ml PRP. 3ml is used for injection and 2ml is used for quality control.

Corticosteroid group

patients rejected with corticosteroid

Group Type: ACTIVE_COMPARATOR

Corticosteroid

Intervention Type: DRUG

Corticosteroid group: after the surgery of rotator cuff repair under arthroscopy, 1mL prednisone (MSD) + 2mL sodium hyaluronate (biochemical Industry Co., Ltd.) was injected under arthroscopy.

Normal saline group

patients rejected with normal saline

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Normal saline

Interventions

platelet rich plasma

Platelet rich plasma group: after the surgery of rotator arthroscopic rotator cuff repair, 3ml PRP (LongTai Biological Company) was injected into the rotator cuff tear under the rotator arthroscope for a time. PRP production process: before anesthesia, 20ml arterial blood was drawn and injected into the PRP tube. The blood was fully oscillated in the tube, and then placed in a centrifuge with 1500g for 9min to remove excess plasma and make 5ml PRP. 3ml is used for injection and 2ml is used for quality control.

Intervention Type: DRUG

Corticosteroid

Corticosteroid group: after the surgery of rotator cuff repair under arthroscopy, 1mL prednisone (MSD) + 2mL sodium hyaluronate (biochemical Industry Co., Ltd.) was injected under arthroscopy.

Intervention Type: DRUG

Normal saline

Normal saline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Rotator cuff tears were diagnosis by magnetic resonance imaging or arthroscopy
• Surgical intervention of rotator cuff tears was proposed.
• Simple full-layer tear of supraspinatus tendon.
• Patients give informed consent, and sign the informed consent form, and the process must meet the requirements of GCP

Exclusion Criteria

• Patients with rotator cuff injuries involving infraspinatus, subscapularis, and teres minor tendon injuries
• Patients platelet concentration is lower than 100×109
• Patients have other shoulder diseases, including osteoarthritis, cervical spondylosis, etc.patients have inflammatory diseases, including rheumatoid arthritis, fibromyalgia, rheumatic polymyalgia, etc.patients have received injection treatment within 3 months.
• Patients have participated in clinical trials or are conducting other clinical trials within 3 months before screening.
• Patients have severe primary cardiovascular disease, lung disease, endocrine and metabolic disease or serious diseases that affect their survival, such as tumor or AIDS, the researchers believe that it is not suitable to be selected.
• Patients have severe liver, kidney and hematological lesions, such as kidney function exceeding the upper limit of normal value and liver function exceeding 2 times the upper limit of normal value.
• Patients have viral hepatitis, infectious diseases, severe abnormalities in blood coagulation and other diseases that the researchers consider unsuitable for surgery.
• Women who are pregnant or lactating, or who plan to conceive during follow-up, those who are positive for human chorionic gonadotropin before sampling; menstrual women should wait for surgery after the end of menstruation.
• Patients have severe neurological and mental disorders.
• Patients suspect or do have a history of alcohol or drug abuse.
• Patients have height body mass index (BMI) > 30.
• Patients have tendon disease caused by systemic immune or other diseases, and patients with diseases or symptoms that may affect pain or function scores.
• Patients have coagulation disorders caused by any other acute or chronic disease.
• MRI detection of contraindications. Include, but are not limited to: installation of pacemakers, defibrillators, cardiac stents, artificial heart valves, metal clips after aneurysm surgery, drug infusion devices implanted in the body, any electronic devices implanted in the body (nerve stimulators, bone growth stimulators), endovascular embolization steel rings, filters, ECG recording monitors, metal sutures, shrapnel or iron particles in the body, fixation of steel plates and nails after fracture surgery, Cochlear implant, middle ear graft, intraocular metal foreign body, etc. Claustrophobia, critically ill patients, etc.
• Refer to the April 2008 edition of the Law of the people's Republic of China on the Protection of disabled Persons, patients belong to the subjects of legal disabled persons
• Other situations in which the researchers judged that the subjects were not suitable to participate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

weiliang shen, doctor

Role: CONTACT

wlshen@zju.edu.cn

86-0571-86995513

Facility Contacts

weiliang shen, Doctor

Role: primary

wlshen@zju.edu.cn

86-0571-86995513

Other Identifiers

2022-0833

Identifier Type: -

Identifier Source: org_study_id