Percutaneous internal fixation with Y-STRUT® device to prevent both osteoporotic and pathological hip fractures: a prospective pilot study

Background: We studied Y-STRUT (R) (Hyprevention, France), a new percutaneous internal fixation device, in combination with bone cementoplasty to prevent hip fracture. Methods: Between February 2013 and February 2015, a total of 16 femoral necks in 4 osteoporotic and 12 oncologic patients have been considered for prophylactic consolidation in this prospective multicentre pilot study involving 4 different hospitals. These consolidations were performed percutaneously under fluoroscopic guidance using Y-STRUT (R), a dedicated internal fixation device. For osteoporotic patients, orthopaedic surgeons performed the prophylactic consolidations immediately after surgical treatment of a hip fracture (same anaesthesia) in the opposite side. For oncologic patients, without current hip fracture but considered at risk (Mirels score >= 8), interventional radiologists performed the procedures. We report the preliminary results of feasibility, safety and tolerance of these preventive consolidations using Y-STRUT (R). Results: Four patients (mean 83 years old) had prophylactic consolidation because of a severe osteoporosis (mean T-score -3.30) resulting in first hip fractures. Ten patients (mean 61 years old) were treated because of impending pathological fractures (mean Mirels score 9) related to femoral neck osteolytic metastases. All the procedures were performed with success. Wound healing was achieved in all cases with no access site complication. Radiographic exams performed at 3 months follow-up revealed that Y-STRUT (R) was well integrated in the bone. For the osteoporotic cohort, mean pain was 0.9 +/- 0.7 at 3 weeks. For the oncologic cohort, it decreases from 3.6 +/- 2.9 at baseline to 2.4 +/- 0.9 at 2 months. Conclusions: Preliminary results demonstrate the feasibility and safety of Y-STRUT (R) implantation as well as the tolerance of the device.