Outcomes of cement augmentation in fragility trochanteric hip fractures - A multicenter randomized controlled trial follow-up

Abstract

Purpose: Cement augmentation is considered to improve the bone-implant construct stability in hip fragility fractures, additionally biomechanical studies show that cement augmentation improves the pull-out strength and increases resistance to failure. Thus far, the advantage of these technique used in a clinical scenario is yet to be determined METHODS: a randomized, multicenter, single-blinded clinical trial was conducted in patients aged 65 years or older who were admitted to two level I trauma centers with a fragility intertrochanteric hip fracture during September 2015 and December 2017. Patients were stratified into 2 groups: patients between 65 and 85 years and older than 85 years. A balanced block randomization was performed using blocks of 6 patients: 3 patients assigned to the control group (no augmentation) and 3 patients to the intervention group. Follow-up visits were done at 1, 3, 6 and 12 postoperative months documenting the tip-apex distance (TAD) as well as followed up after 5 to 7 years of surgical procedure documenting EQ5D, Parker Mobility Score and mortality rates at these different time points.

Results: A total of 90 patients were included but only 53 patients completed a one-year follow up. The mean immediate postoperative and one-year follow up TAD measurement from the whole cohort (20.99 mm vs 21.3 mm, respectively) showed no statistical significance (P = 0.18). For patients in the control group, the difference of TAD measurements from the immediate postoperative and one-year follow-up was -0.25 mm (P = 0.441). For patients included in the intervention group, the difference of TAD measurement from the immediate postoperative and 1-year follow up was -0.48 mm (P = 0.383). No statistical difference was found when stratified by age (p = 0.78). One patient from the control group had an implant failure after 1-month postoperative. Readmission after 30 days showed no statistical difference between both groups (7 vs. 7 patients, p = 0.754). Augmentation did not show a difference in most of the functional outcomes nor quality of life after 5 to 7 years of surgical procedure.

Conclusions: The use of augmentation can be considered a safe procedure for the fixation of fragility hip fractures.