Treatment of Early-Stage Osteonecrosis of the Femoral Head Using Core Decompression With or Without Autologous Bone Marrow Aspirate Concentrate

What this Trial Is About

Osteonecrosis of the femoral head ONFH is a painful condition where bone cells in the hip die, leading to the collapse of the femoral head and potentially arthritis. This condition often affects younger adults in their 20s and 30s, and joint-preserving treatments are important to delay or avoid joint replacement surgery. This study aims to compare core decompression surgery alone with core decompression combined with autologous bone marrow aspirate concentrate BMAC to see which method leads to better clinical and imaging results in early-stage ONFH. Participants will be randomly assigned to one of two groups one receiving core decompression alone with a sham bone marrow aspiration, and the other receiving core decompression plus concentrated bone marrow aspirate injected into the hip bone. The bone marrow sample will be analyzed to understand the cells and biological pathways involved. Both procedures follow a standardized protocol to ensure consistency across participants. Throughout the study, participants will be monitored with routine surgical follow-ups and assessments including radiographs, MRIs, and questionnaires at multiple time points up to 24 months. Key outcomes measured include radiological progression of ONFH, pain levels using the Pain Visual Analog Scale, and time until treatment failure. Additional assessments of symptoms, function, quality of life, and mental and physical health will be collected at baseline, 6, 12, and 24 months. This study will help understand which treatment better preserves the hip joint in early ONFH cases.

Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis