Institutional Review Board, Hospital for Special Surgery
December 07, 2023
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Fibrosis and inflammation are two biological processes that play a key role in the development and progression of rotator cuff tears (RCTs). Unfortunately, there are no interventions at present that reduce the fibrosis an inflammation associated with orthopedic injuries, including RCTs. Epigallocatechin gallate (EGCG) is a widely available nutritional supplement derived from green tea that has been studied in a variety of conditions, ranging from diabetes to cancer. EGCG has shown promise as an anti-fibrotic medication in several fibrosing conditions. This clinical trial will evaluate the effectiveness of EGCG at reducing local tissue fibrosis after RCT. A total of 28 patients who are indicated to undergo rotator cuff repair will be enrolled in this randomized clinical trial.
Criteria for inclusion: patients aged 40 to 75 years undergoing shoulder arthroscopy with repair of rotator cuff tendons (supraspinatus, infraspinatus). Patient may also be undergoing biceps tenotomy or tenodesis, subacromial decompression, acromioplasty and/or distal clavicle resection.
• Patients with acute traumatic rotator cuff tears for injuries or dislocation events will be excluded. Symptoms must have been present for at least 3 months prior to study enrollment.
• Any additional procedures beyond biceps tenotomy or tenodesis, subacromial decompression, acromioplasty and/or distal clavicle resection.
• Subscapularis tendon repair
• Previous ipsilateral shoulder surgery
• Inflammatory arthritis, diabetes, organ transplantation or other chronic immunosuppression
• Chronic NSAID use that cannot be discontinued
• Connective tissue disorder such as Ehlers-Danlos or Marfan Syndrome
• Previous cytotoxic chemotherapy
• Pre-existing osteoarthritis as defined by any full thickness cartilage loss on MRI.
• If previously diagnosed with COVID-19, must be symptom free for a minimum of 3 months.
• Allergy to EGCG or green tea
• History of liver disease or abnormal liver function testing
• Patients whose surgery must be scheduled in less than 2 weeks
Laura Moore, MD PhD