Bone grafting and internal fixation of intracapsular femoral neck fracture. Two years follow up in five patients with a novel fixation device.

Objectives: To test the safety and effectiveness of a novel procedure and device for fixation of displaced or non-displaced intracapsular femoral neck fractures, in order to preserve the natural femoral head and prevent the need for partial or total hip replacement. Design: Singlearm, prospective clinical investigation. Setting: Patients admitted to the Orthopedic Department. Participants: Male and female patients between the ages of 50 and 75 with a Garden I-III type intracapsular femoral fracture.Intervention: Internal fixation with the WaisFix 100i device, and bone graft with bone substitute. Measurements: Experimental and computer simulator testing prior to clinical evaluation by mechanical and numerical modeling, and clinical and radiological follow-up. Results: Five women with Garden I-III type intracapsular femoral fracture underwent internal fixation and bone graft with the WaisFix 100i device. The operations were performed 8 to 26 hours following the traumatic event. There were no peri-operative complications or infections, and bleeding was negligible. The average hospitalization following surgery was 4 days, and hospital rehabilitation time was two weeks. Clinical and radiological bone union (eight to ten weeks) and optimal alignment were achieved in all cases. No cases of avascular necrosis, mechanical device failure or indication for hip replacement were observed after >2 years. Conclusion: At >2-years follow-up, the WaisFix100i internal fixation device and bone graft for intracapsular femoral neck fractures demonstrated safety, assessed by lack of complications; and effectiveness, assessed by rigid and stable fixation and short healing time.