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Abstract
Purpose
The aim of this study is to investigate the clinical performance and safety of Zimmer® natural nail cephalomedullary nail (ZNN CM nail) in the treatment of proximal femur fractures.
Materials and Methods
The following research was conducted as a prospective, non-comparative, single center outcome study. Upon providing written informed consent, enrolled patients’ data were collected and analyzed. Postoperative follow-up visits were scheduled at 6 weeks, 3 months, 6 months, and 1 year. Follow-up evaluation included radiographic assessment, physical examination, and quality of life and adverse events reports.
Results
Thirty-nine patients were available for evaluation at one year postoperative. The patients reported the mean EuroQol-5 Dimension score increased after surgery: from 0.4 points at discharge (n=49) to 0.6 points at 1-year post-surgery (n=39). The mean Harris hip score also increased after surgery: from 56.3 points at discharge (n=49) to 72.1 points at 1 year (n=12). Bone union was seen in 64% (n=16) in 6 months and 95% (n=37) in 1 year.
References
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Fig. 1.
(A) Hip antero-posterior (AP) view of left intertrochanteric fracture immediately postoperation. Medial and lateral (LAT) cortex fracture gap at the fracture site is depicted by white arrows. (B) Hip left LAT view of intertrochanteric fracture immediately postoperation. Anterior and posterior cortex fracture gap at the fracture site is depicted by white arrows. (C) Hip AP view of left intertrochanteric fracture 6 months postoperation. Medial cortex shows no fracture gap (white triangles) and callus formation is observed. (D) Hip left LAT view of femur intertrochanteric fracture 6 months postoperation. Anterior and posterior cortex shows no fracture gap (white triangles) and callus formation is observed.
Fig. 2.
Patient enrollment and follow-up flow chart. This study involved intertrochanteric or subtrochanteric fractures in 39 patients requiring cephalomedullary nailing. FUP: follow-up percentage.
Fig. 3.
Mean EuroQol-5 Dimension (EQ-5D) score. Mean value of EQ-5D score measured in outpatient clinic using questionnaires at each follow-up period. Scores tend to increase from the EQ-5D baseline over time.
Fig. 4.
Mean Harris hip score (HHS). Mean value of HHS measured in outpatient clinic questionnaires at each follow-up period. Scores tend to increase from the HHS baseline over time.
Fig. 5.
Weight bearing without pain. Proportion of weight bearing without pain observed in outpatient clinic at each follow-up period. Proportion of weight bearing without pain increases over the followup period.
Fig. 6.
Radiologic fracture healing. Radiologic bone union rate confirmed on plain radiographs at each follow-up period. Radiologic bone union rate increases over the follow-up period.
Fig. 7.
Example of the Zimmer natural nail. The proximal diameter of the instrument is reduced from 16 to 15.5 mm as depicted by the dotted outline. Proximal lateralization angle of the instrument is decreased from 5 to 4 degrees as depicted by the square-ended outlines. The caput-columndiaphyseal (CCD) angle is depicted by the dotted-arrow lines.
Table 1.
Baseline Characteristics Included in This Study
Table 2.
Intra- and Postoperative Variables
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