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.
Knee stiffness after anterior cruciate ligament (ACL) tear and reconstruction is a complex and common problem. Although there are numerous contributing factors to knee stiffness, fibrosis and inflammation are two of the key biological processes behind it. Currently there are no interventions to reduce fibrosis and inflammation after orthopedic injuries, such as ACL tear.
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 ACL rupture and improving range of motion after ACL reconstruction. A total of 28 patients who are indicated to undergo ACL reconstruction will be enrolled in this randomized clinical trial
Criteria for inclusion: Patients aged 18-50 undergoing reconstruction for rupture of ACL within the previous 3 months. Patients may also be undergoing simultaneous partial medial and/or lateral meniscectomy and chondroplasty.
ACL Exclusion Criteria:
• Age < 18 or > 50 years
• Time from injury to surgery greater than 3 months.
• Any additional procedure beyond arthroscopy with meniscus surgery (medial and/or lateral) or chondroplasty (any compartment)
• Previous ipsilateral knee surgery
• Pre-existing osteoarthritis as defined by any full thickness cartilage loss on MRI
• 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
• If previously diagnosed with COVID-19, must be symptom free for 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