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

Zhejiang University

Status and phase: Enrolling; Phase 4

Conditions: Tendinopathy

Treatments: Drug: Normal saline; Drug: Corticosteroid; Drug: platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT05603468

2022-0833

Details and patient eligibility

About

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

Full 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.

Enrollment: 387 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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387 participants in 3 patient groups, including a placebo group

Platelet Rich Plasma group

Experimental group

Description:

patients rejected with platelet rich plasma

Treatment:

Drug: platelet rich plasma

Corticosteroid group

Active Comparator group

Description:

patients rejected with corticosteroid

Treatment:

Drug: Corticosteroid

Normal saline group

Placebo Comparator group

Description:

patients rejected with normal saline

Treatment:

Drug: Normal saline