The same surgical technique was used for both groups. For each operation, 1 surgeon was in charge with 2 scrubbed or unscrubbed assistants. Close reduction was achieved with longitudinal traction in line with the axis of the femur to achieve the original limb length. Limb rotational alignment was confirmed on the basis of lesser trochanter shape sign.3 Reduction was facilitated with a percutaneous ball spike pusher or K wire, if needed. With both reduction techniques, the fracture was fixed with a cephalomedullary nail (proximal femoral nail antirotation; Shandong Hangwei, China). Under fluoroscopic guidance, the selected cephalomedullary nail was inserted across the fracture. Once reduction and nail position were suitable, the cephalic blade was inserted through the nail and into the femoral head with a tip–apex distance of <25 mm using the attached targeting device through stab incisions (for IFFRD, Figs. 3A–F). Distal screws were locked via a mini-incision. We recorded the duration of positioning (transfer from stretcher to normal radiolucent table for IFFRD or TT and positioning), closed reduction and nail insertion (from the beginning of IFFRD assembly or TT manipulation until locking of the distal screw), and fluoroscopy (from activating the foot pedal to image visualization), as well as total operative duration (from beginning of positioning to the end of nail insertion, during which fluoroscopy time was also included). Postoperative management was according to standard protocols.
Radiographs (posterior-to-anterior and lateral views) were obtained on postoperative days 1 or 2. Quality of fracture reduction was graded as good, acceptable (5–10 degrees varus/valgus and/or ante- or retroversion), or poor (>10 degrees varus/valgus and/or ante- or retroversion). Patients underwent clinical and radiological reviews 6 weeks after successful hospital discharge and at 3, 6, and 12 months. Radiographs were analyzed by an independent senior radiologist blinded to group information. Time from surgery to union or failure, complications, and further procedures, if needed, were reviewed.
There were 5 deaths (3—TT and 2—IFFRD) because of comorbidities [heart failure (n = 2); pulmonary infection (n = 3)] within 1 month postoperatively. Six patients (4—TT and 2— IFFRD) finished 6-month follow-up but could not be contacted or refused to return for the 1-year follow-up evaluation. These 11 patients were excluded from this study. The remaining 130 patients (69 cases in the IFFRD group and 61 cases in the TT group) were followed for a minimum of 1 year postoperatively.
Values of all parameters are presented as mean ± SD. Data were analyzed using the Fisher exact and t tests, with results deemed significant at P < 0.05. SPSS 22.0 (SPSS Inc, Chicago, IL) was used for statistical analysis.
There were no significant differences in age, sex, laterality, American Society of Anesthesiologists grade, preoperative motility, residence status, or fracture classification between the groups (P > 0.05, Table 1). The time required for patient positioning was longer in the TT group (17.82 ± 1.48 minutes) than the IFFRD group (7.26 ± 1.73 minutes; P < 0.05). Durations of surgery (IFFRD, 39.67 ± 3.01 minutes; TT, 41.83 ± 3.31 minutes) and fluoroscopic examination (IFFRD, 3.78 ± 0.78 minutes; TT, 3.91 ± 0.60 minutes) were comparable between the groups (P > 0.05). Total operative duration was longer in the TT group (59.65 ± 3.89 minutes) than the IFFRD group (46.93 ± 3.51 minutes) (P < 0.05). Throughout all 69 IFFRD procedures, 1 scrubbed assistant assembled the IFFRD. In the TT group, a scrubbed assistant was required only during fracture reduction (6/61 procedures) (P < 0.05). No instances of IFFRD failure, including loosening, cut-out of Steinmann pins, or bone fractures at the insertion site, were recorded intraoperatively in this study.
Duration of follow-up ranged from 12–18 months in both groups. Average follow-up was 12.19 ± 1.02 months in the IFFRD group and 12.20 ± 1.08 months in the TT group. No fracture reductions were assessed to be poor postoperatively in either group. Union occurred in all patients of both IFFRD and TT groups. Postoperative fixation failed in 3 IFFRD patients (8, 9, and 14 months postoperatively) and 2 TT fractures (8 and 10 months postoperatively) because of lag screw cut-out postoperatively after weight-bearing.
The IFFRD can be rapidly assembled in a minimally invasive manner and facilitates fracture reduction and nail insertion because of easy abduction and adduction of the hip joint at will. The anteroposterior supra-acetabular proximal pin is located at the thickest portion of the iliac wing and is firm enough to act as an ideal fulcrum for fracture reduction. The distal connecting point in the middle of the arc-like frame is directly above, in parallel with, the long axis of the patella. The caudal part of the distal arc-like frame is triangular in the sagittal plane, providing sufficient stability with resistance once the distal sliding carriage is stretched to distract the fracture site. As shown in Figure 2H, the IFFRD was well aligned with the long axis of the femur and produced axial distraction forces that were large enough for satisfactory bone fracture reduction. We conducted a pilot study on cadavers and found that, after insertion, both proximal and distal pins could sustain forces up to 26.84 and 28.33 kg, respectively, before pin deformity.
Posterior sag is largely alleviated because the injured lower leg is sustained by the distal part of the radiolucent operating table and can be resolved with bumps, pads, or inflatable floats.4 Although a TT can help achieve the original limb length, external rotation of the proximal fragment because of the short external rotators is possible. Internal rotation of the distal lower leg with the ipsilateral patella oriented anteriorly is a common solution, but only suitable for OTA type A1.1–2.1 fractures; fractures with ≥2 independent fragments (OTA 2.2–3.3), if fixed after internal rotation, are predisposed to malrotation deformities that must be corrected.5 However, with the IFFRD, the support underneath the injured side can not only counteract the external rotation force on the proximal fragment to some extent but also raise the horizontal level of the entry point at the greater trochanter. It may then be easy to perform fracture reduction and nail insertion.
Zhang's reductor has also been indicated for rapid femoral shaft fracture reduction6 and can be indicated for trochanteric fractures as well; it has a proximal pin insertion site (anterior superior iliac spine) and a different distal design. Although anterior-superior iliac spine or AIIS access is equally easy, the excellent supra-acetabular bone stock used by the IFFRD is biomechanically advantageous over the gluteus medius tubercle and pillar used by Zhang's reductor.7 In contrast to the smaller, simpler, triangular distal IFFRD, the distal Zhang's reductor, a 4-legged scaffold combining a distal pin with a connected traction bow, must be supported by a table during traction.6
After completion of this study, we improved the distal structure of IFFRD to simplify assembly and widen its indications. The IFFRD plus a tibia set (for tibia fractures) is currently commercially available (ShanDong HangWei medical instruments, China) for a low price (less than 5000 USD). Therefore, the application of IFFRD may be cost effective. Capital equipment costs may decrease because multiple, expensive fracture tables are not needed. Although scrubbed assistants assemble the IFFRD, their cost is offset by the short operative duration, simple surgical procedure, and wide indications besides trochanteric fractures and shaft fractures of the femur. We applied this device for closed reduction and cephalomedullary nail insertion of trochanteric fractures and found that the IFFRD is efficient, reliable, and easy to use.
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5. Riehl JT, Widmaier JC. Techniques of obtaining and maintaining reduction during nailing of femur fractures. Orthopedics. 2009;32:581.
6. Chen W, Zhang T, Wang J, et al. Minimally invasive treatment of displaced femoral shaft fractures with a rapid reductor and intramedullary nail fixation. Int Orthop. 2016;40:167–172.
7. Cole PA, Dyskin EA, Gilbertson JA. Minimally-invasive fixation for anterior pelvic ring disruptions. Injury. 2015;46(suppl 3):S27–S34.
trochanteric fracture; closed reduction; intraoperative femoral fracture reduction device; traction table
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