Porous Tantalum Rods Improve the Hip Joint Function of Patients With Avascular Necrosis of the Femoral Head After Femoral Neck Fracture Surgery: a Randomized Controlled Trial

History and current status of related studies: Femoral neck fracture can render the blood supply to the femoral head insufficient, leading to avascular necrosis of the femoral head. This often increases treatment difficulty and can have a strong influence on the recovery of hip joint function. Although core decompression for treatment of avascular necrosis of the femoral head has been largely used in clinical settings, the mid-term therapeutic effects are not satisfactory in some patients.

Biocompatibility is defined as the ability of a biomaterial, prosthesis, or medical device to perform with an appropriate host response. The biocompatibility of a bone implant and host influences the therapeutic effects. Therefore, biomaterials that are less likely to induce negative host responses may increase the therapeutic effects of such treatments for orthopedic diseases. A porous tantalum rod is a bone trabecula-like metal implant that is used to support weight-bearing areas of necrotic bone, preventing further collapse of the necrotic area. This implant has exhibited favorable effects in the early treatment of avascular necrosis of the femoral head. Although previous reports have focused on porous tantalum rod implantation for clinical treatment of avascular necrosis of the femoral head after fermoral neck fracture, few have assessed the long-term therapeutic effects or biocompatibility of porous tantalum rods.

Adverse events Possible adverse events include any expected or unexpected symptoms. If severe adverse events occur, information including the date of occurrence and measures taken related to the treatment of the adverse events will be reported to the principal investigator and the institutional review board within 24 hours.

Data collection, management, analysis, and open access Data collection: Case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events will be collected , processed using Epidata software, collated, and then electrically recorded using a double-data entry strategy by data managers.

Data management: The locked electronic database will not be altered in any way, and will only be available to the project manager. Paper and electronic data regarding screening, informed consent, and clinical outcomes will be preserved at the Affiliated Hospital of Nantong University, China.