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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Oct 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different treatments—Platelet-Rich Plasma (PRP) and corticosteroids—on patients with specific types of rotator cuff tendinopathy, which is a common shoulder injury. The goal is to see which treatment works better for healing the shoulder after surgery to repair the rotator cuff. The trial involves several medical centers and is looking for participants aged 65 to 74 years old.

To qualify for this study, participants must have a diagnosed rotator cuff tear, which will be confirmed through imaging tests. They should be scheduled for surgery to fix the tear and have a simple tear in the supraspinatus tendon, one of the key muscles in the shoulder. However, individuals with certain other shoulder injuries or serious health conditions, such as severe heart or lung disease, will not be eligible. Participants can expect to be randomly assigned to receive either PRP, corticosteroids, or a placebo (a treatment without active medicine) as part of their care. The research team will guide them through the process to ensure they understand what to expect during the trial.

Gender

ALL

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.