Comparing PRP and corticosteroids for treating rotator cuff tendinopathy
Effect of Platelet-Rich Plasma vs Corticosteroid Injection in Distinct Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair: a Multicenter, Three-group, Randomized Controlled Trial
PHASE4 · Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT05603468
This study is testing whether platelet-rich plasma or corticosteroids work better for treating different types of rotator cuff tendinopathy during surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 387 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05603468 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of platelet-rich plasma (PRP) versus corticosteroids in treating different subtypes of rotator cuff tendinopathy during arthroscopic repair. It employs a multicenter, randomized, single-blinded, parallel group design, utilizing machine learning to identify molecular and clinical features for rapid recognition of tendinopathy subtypes. The study aims to establish a specific treatment regimen by comparing the clinical outcomes of PRP, corticosteroids, and a placebo. Participants will be closely monitored to assess the effectiveness of these interventions.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with simple full-layer tears of the supraspinatus tendon who are scheduled for surgical intervention.
Not a fit: Patients with injuries involving other shoulder tendons or those with inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more tailored and effective treatment approach for patients with rotator cuff tendinopathy.
How similar studies have performed: Other studies have shown promise in using PRP for tendinopathy, but this specific approach of subtype differentiation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: weiliang shen, doctor
- Email: wlshen@zju.edu.cn
- Phone: 86-0571-86995513
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tendinopathy, Platelet Rich Plasma