Rotator cuff injury
Conditions
Interventions
Control group:Placebo
Intervention group:Icosapent Ethyl Soft Capsules
Sponsors
Shanghai Sixth People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old (inclusive), gender unrestricted. 2. Clinically and through imaging (MRI), it was confirmed as a moderate-sized (with the maximum tear diameter of 1-3 cm) full-thickness rotator cuff tear. The patient has successfully undergone the first arthroscopic double-row suture or suture bridge technique for rotator cuff repair without the use of enhanced patches or grafts. The postoperative vital signs were stable. 3. The following lipid and treatment background is met: (1) Diagnosed with atherosclerotic cardiovascular disease (ASCVD), or have type 2 diabetes and at least two other cardiovascular risk factors (such as hypertension, smoking, low HDL-C, etc.); (2) Undergoing stable-dose statin therapy for at least 4 weeks; (3) Fasting serum triglyceride (TG) level >= 1.7 mmol/L (approximately 150 mg/dL). 4. Voluntary participation in this study and signing of the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. It is known that one is allergic to fish or shellfish, or to any component of the research drug/placebo. 2. Women who plan to become pregnant during the study, are currently pregnant, or are breastfeeding. 3. Have a severe bleeding disorder (such as hemophilia) or are using therapeutic doses of anticoagulant drugs (such as warfarin), but are allowed to use prophylactic doses of low-molecular-weight heparin or new oral anticoagulants. 4. Severe liver dysfunction (Child-Pugh grade B or C) or renal dysfunction (eGFR < 30 mL/min/1.73 m^2). 5. Having poorly controlled thyroid disease. 6. Have a history of atrial fibrillation or atrial flutter, or have experienced an acute coronary syndrome, stroke or other major cardiovascular event within the previous 3 months before enrollment. 7. Merge other diseases that may significantly affect the assessment of shoulder joint function, such as advanced osteoarthritis of the shoulder joint, shoulder joint dysfunction caused by neurological diseases, non-healed fractures of the contralateral upper limb, local (shoulder joint) or systemic active infections, or a history of shoulder joint infection within 6 months prior to enrollment. 8. Was using other omega-3 fatty acid-containing health supplements or medications for a long period of time (within 1 month before enrollment) with a dosage of more than 1g per day. 9. The researcher determines that there are any other circumstances that make participation in this clinical trial unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Constant-Murley Shoulder Function Score;Adverse Event Incidence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rotator Cuff Tendon Healing Rate;Visual Analogue Scale for Pain (VAS); | — |
Countries
China
Contacts
Public ContactXin Ma
Shanghai Sixth People’s Hospital
Outcome results
None listed