Efficacy and safety of cemented and cementless prostheses in the repair of unstable intertrochanteric fractures in the elderly: study protocol for a non-randomized controlled trial

<b>Background and Objectives:</b> Patients with unstable intertrochanteric fractures are older, and body function gradually degrades with age. The reduction and fixation of these fractures are difficult. Total hip arthroplasty is one of the main surgical treatments for unstable intertrochanteric fractures in the elderly. This trial was designed to identify the differences between cemented and cementless prostheses in the repair of unstable intertrochanteric fractures in the elderly so as to provide a clinical basis for the selection of hip prostheses for treating unstable intertrochanteric fractures in elderly patients.<br><b>Design:</b> A prospective, single-center, non-randomized, controlled, clinical trial. <br><b>Methods:</b> Eighty-six elderly (> 65 years old) patients at the Harrison International Peace Hospital of China with unstable intertrochanteric fractures underwent total hip arthroplasty. Forty-four patients in the control group received a cemented SPII prosthesis (Link, Hamburg, Germany). Forty-two patients in the trial group received a cementless Wagner prosthesis (Zimmer, Spartanburg, SC, USA). All patients were followed for 6 months. <br><b>Outcome measures:</b> The primary outcome was an excellent or good Harris hip score at 6 months postoperatively to evaluate the recovery of hip function. The secondary outcomes were the changes in Harris hip scores or morphological changes in the hip on X-ray preoperatively and 1, 3, and 6 months after surgery, intraoperative blood loss, operative time, postoperative blood transfusion volume, ambulation time, amount of drainage at the incision 1 month after surgery, and the incidence of adverse reactions at 6 months after surgery. <br><b>Results:</b> Postoperative blood transfusion volume and the amount of drainage were higher in the trial group than in the control group (<i>P</i> < 0.05). The rate of excellent or good Harris hip scores was not significantly different between the trial and control groups (<i>P</i> > 0.05). Harris scores were lower in the trial group than in the control group at 1 and 3 months postoperatively (<i>P</i> < 0.05). The incidence of adverse reactions was not significantly different between the two groups at 6 months after surgery (<i>P</i> > 0.05), but bone cement poisoning was found in four patients in the control group.<br><b>Conclusion:</b> Efficacy and safety of cemented and cementless prostheses for unstable intertrochanteric fractures in the elderly were good. However, the cemented prosthesis was associated with a risk of bone cement poisoning. <br><b>Trial registration:</b> Clinical Trails.gov indentifier: NCT03193697.<div><br></div><div><div>DOI: 10.4103/2542-4157.213689</div><div><br></div><div>How to cite this article:</div><div>Yu Tm, Miao Hl. Efficacy and safety of cemented and cementless prostheses in the repair of unstable intertrochanteric fractures in the elderly: study protocol for a non-randomized controlled trial. Clin Trials Orthop Disord 2017;2:97-103</div>