Randomised control trial on management of early avascular necrosis of femoral head by core decompression with bisphosphonate therapy versus core decompression in tertiary care hospital in central India

Abstract

Background This study outlines a randomised control trial to assess the efficacy of Core Decompression with and without Bisphosphonate Therapy in managing early Avascular Necrosis of the femoral head. Avascular Necrosis, a debilitating condition, necessitates exploration of interventions to mitigate progression. The trial is conducted at Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital, Sawangi, Wardha, focusing on clinical, radiographic, and patient-reported outcomes. Methods Skeletally mature participants diagnosed with stage 1 or 2 Avascular Necrosis of the femoral head will be randomly assigned to either Core Decompression with Bisphosphonate Therapy or Core Decompression Alone. Data collection from July 2022 to September 2024 will involve preoperative assessments, intraoperative details, postoperative care records, and followup evaluations at six weeks, three months, six months, and nine months. Statistical analyses will encompass primary outcomes assessed by Harris Hip Score, secondary outcomes including pain reduction and radiographic changes, and subgroup analyses. Expected Outcome Anticipated outcomes involve insights into the comparative effectiveness of the two interventions. Primary analyses will reveal variations in Harris Hip Score changes over time, while secondary analyses will shed light on pain reduction, radiographic changes, and potential complications. Subgroup analyses may discern nuances based on etiological factors. The results aim to inform clinical practice, guiding the optimal management of early Avascular Necrosis of the femoral head.