Clinical Trials for Epiphysiolysis
Currently, there is 1 ongoing clinical trial investigating treatments for epiphysiolysis and related hip conditions in children. This trial focuses on reducing blood loss during hip surgery using tranexamic acid, a medication that helps control bleeding during surgical procedures. The study is being conducted in the Netherlands and is open to children between 1 and 18 years of age who require hip bone surgery.
Clinical trial locations
A study of tranexamic acid to reduce blood loss during hip surgery in children with hip dysplasia and other hip conditions
This clinical trial is investigating whether tranexamic acid can effectively reduce the amount of blood lost during hip surgery in children. The study focuses on several hip conditions affecting young patients, including Slipped Capital Femoral Epiphysis (where the upper end of the thigh bone slips backward), Legg-Calvé-Perthes Disease (a condition where blood supply to the hip joint is temporarily interrupted), and Developmental Dysplasia of the Hip (where the hip joint hasn’t formed normally from birth).
Who can participate:
Children between 1 and 18 years of age who need hip bone surgery are eligible for this trial. The surgery must involve either the upper part of the thigh bone, the hip socket, or both. The trial accepts patients requiring surgery for various reasons, including slipped growth plate in the hip, hip joint development problems, or muscle and nerve conditions affecting the hip. Both boys and girls can participate, and the surgery must be scheduled at the study hospital. For patients under the age of consent, a parent or legal guardian must agree to their participation.
Who cannot participate:
Children with a history of blood clotting disorders or those currently taking blood-thinning medications cannot join this trial. The study also excludes patients with known allergies to tranexamic acid, active bleeding disorders, or severe kidney problems. Other exclusion criteria include a history of seizures or epilepsy, current urinary tract bleeding, color vision deficiency, recent blood transfusions within the last 3 months, severe liver disease, uncontrolled high blood pressure, or participation in other clinical trials.
What the trial involves:
The study uses a randomized approach, meaning that some patients will receive tranexamic acid through an injection into their vein before surgery, while others will receive a placebo containing only saline solution. The surgical procedures involved are proximal femoral osteotomy and pelvic osteotomy, which are operations where surgeons make controlled cuts in the hip bones to improve their position and function.
During the trial, medical staff will take blood samples before surgery to measure baseline blood values. On the day of surgery, patients will receive either tranexamic acid or saline through an intravenous line before the procedure begins. Throughout the operation, the medical team will carefully monitor and record the amount of blood loss. After surgery, blood samples will be taken again to check blood values, and the team will monitor for any complications and document whether blood transfusions are needed. The duration of the hospital stay will also be recorded as part of the study data.
Investigational treatment:
The main medication being tested is tranexamic acid, which helps reduce bleeding during surgery by preventing blood clots from breaking down too quickly. This medication has been used safely in both adults and children to manage surgical bleeding and is particularly useful in orthopedic procedures like hip surgeries. The placebo used in the study is an inactive substance containing no medication, allowing researchers to measure how effective tranexamic acid really is at reducing blood loss compared to no treatment.
Summary
Currently, there is one active clinical trial addressing blood loss management during hip surgery for children with epiphysiolysis and related hip conditions. The trial is being conducted in the Netherlands and represents an important effort to improve surgical outcomes for young patients requiring hip bone operations. The study focuses specifically on tranexamic acid, a well-established medication used to control bleeding during surgical procedures. By comparing outcomes between patients who receive the medication and those who receive a placebo, researchers aim to provide clear evidence about whether this treatment can effectively reduce blood loss during pediatric hip surgeries. This research is particularly valuable as it addresses a specific need in pediatric orthopedic surgery, where managing blood loss is crucial for patient safety and recovery.