The primary aim of this study is determine if decompression coring procedures result in a substantial improvement in pain and mobility compared to standard care non-weight baring in sickle cell disease (SCD). As a secondary objective, this multi-institutional collaborative study is designed to follow a standardized protocol that will characterize and compare the radiographic, histologic and surgical course of patients. SCD is the most common cause of avascular necrosis (AVN) of the hip in young patients. By age 25 almost half of all SCD patients have AVN. Eventual total collapse of the femoral head eventually necessitates hip replacement. Unfortunately, his arthroplasty fails in over 50-75% of cases. A major focus of the health community is to develop effective therapy that will half the progression of early AVN. The National Preoperative Transfusion Study Group recently reported a high perioperative morbidity rate with hip replacement and experience with decompression coring. A pilot prospective study to evaluate decompression coring in 13 hips was completed and demonstrated long-term improvement in both pain and range of motion in all early stage hips. Based on the preliminary data in SCD and non-SCD, a multi-institutional prospective study by SCD experts, orthopedic surgeons and physiatrists is planned to determine the efficacy od decompression coring in SCD. The study will randomize 100 patients with early AVN to a standardized program of non- weight bearing with crutches for 6 weeks versus decompression coring procedure. All patients will follow standard care protocols including Harris hip score and Oberg scale of lower extremity function, radiographic and laboratory testing every 3 to 6 months for an average of 3 years. Radiographic (MRI) and histologic sections of the core biopsy will be centrally analyzed. The extent of the lesion on MRI and pathology will be quantitated and compared to the clinical course in order to investigate the predictors of outcome. In summary, this study if successful, will change the approach to hip disease in SCD patients and result in improved quality of life and decreased morbidity from Surgery.
Showing the most recent 10 out of 207 publications
