Abstract
INTRODUCTION
Combining novel diverse population-based software with a clinically-demonstrated implant design is redefining total hip arthroplasty. This contemporary stem design utilized a large patient database of high-resolution CT bone scans in order to determine the appropriate femoral head centers and neck lengths to assist in the recreation of natural head offset, designed to restore biomechanics. There are limited studies evaluating how radiographic software utilizing reference template bone can reconstruct patient composition in a model. The purpose of this study was to examine whether the application of a modern analytics system utilizing 3D modeling technology in the development of a primary stem was successful in restoring patient biomechanics, specifically with regards to femoral offset (FO) and leg length discrepancy (LLD).
METHODS
Two hundred fifty six patients in a non-randomized, post-market multicenter study across 7 sites received a primary cementless fit and fill stem. Full anteroposterior pelvis and Lauenstein cross-table lateral x-rays were collected preoperatively and at 6-weeks postoperative. Radiographic parameters including contralateral and operative FO and LLD were measured. Preoperative and postoperative FO and LLD of the operative hip were compared to the normal, native hip. Clinical outcomes including the Harris Hip Score (HHS), Lower Extremity Activity Scale (LEAS), Short Form 12 (SF12), and EuroQol 5D Score (EQ-5D) were collected preoperatively, 6 weeks postoperatively, and at 1 year.
RESULTS
The mean age is 62 years old (range 32 – 75), 136 male and 120 female, BMI 29.7. The preoperative FO and LLD of the operative hip were 43.5 mm (±9.0 mm) and 3.0 mm (±6.5 mm) compared to the native contralateral hip, respectively. The postoperative FO and LLD were 46.4 mm (±8.7 mm) and 1.6 mm (±7.6 mm) compared to the native contralateral hip, respectively. The change in FO on the operative side was 3.0 mm (±7.2 mm) (p<0.0001) and the change in LLD from preoperative to 6-weeks postoperative was 1.6 mm (±8.4 mm) (p=0.0052) (Figure 1), demonstrating the ability of this stem design to recreate normal hip biomechanics in this study. The HHS increased considerably from a preoperative score of 55.9 to 78.4 at 6 weeks and 92.7 at 1 year. Clinically significant improvements were also seen at 1 year in the LEAS (+2.3), SF12 PCS (+16.3), and EQ-5D TTO (+0.26) and the EQ-5D VAS (+15.7).
DISCUSSION and CONCLUSION
This study demonstrated that recreation of normal anatomic leg length and offset is possible by utilizing a modern fit and fill stem that was designed by employing an advanced anthropomorphic database of CT scans. We hypothesize that when surgeons utilize this current fit and fill stem design, it will allow them to accurately recreate a patient's natural FO and leg length, assisting in the restoration of patient biomechanics.
Summary Sentence
In this study, modern design methods of a press-fit stem using 3D modeling tools recreated natural femoral offset and leg length, assisting in the restoration of patient biomechanics.
