Cerclage Fixation of Third Fragment in Femoral Shaft Fracture is That Necessary

The aim of this study is to compare closed reduction and intramedullary nailing with open reduction, cerclage fixation of the third fragment and intramedullary nailing in skeletally mature patients with femoral shaft fractures containing a third (wedge or butterfly) fragment. Written informed consent was obtained from every patient before enrolment.

Patients were randomly allocated in a 1:1 ratio using a computer-generated sequence with permuted blocks, concealed in sequentially numbered sealed opaque envelopes opened in the operating theatre after enrolment and anaesthesia. Blinding of surgeons was not possible because the two techniques differ visibly.

Group 1 (Closed group) (21 cases): reduction was performed without opening the fracture site, followed by antegrade or retrograde intramedullary nailing.

Group 2 (Open group) (21 cases): the fracture site was exposed, the third fragment was reduced with a bone clamp and stabilized with cerclage wiring, followed by antegrade or retrograde intramedullary nailing.

Preoperative radiographs and, when available, computed tomography were used to measure third-fragment length, width, projected area and displacement. Follow-up radiographs were obtained at approximately six weeks, three months, six months and nine months. Healing was assessed using the Radiographic Union Score for Femur (RUSF) by two independent reviewers. Union was defined as bridging callus across at least three of four cortices with painless full weight bearing, delayed union as failure to achieve union by six months, and nonunion as failure to achieve union by nine months. Operative time, intraoperative blood loss, infection and other postoperative complications were recorded.

Procedure: closed reduction and intramedullary nailing. The fracture is reduced without opening the fracture site, followed by antegrade or retrograde intramedullary nailing; the third fragment is not directly fixed.

Procedure: Closed reduction and intramedullary nailing

Procedure: open reduction, cerclage fixation and intramedullary nailing. The fracture site is exposed, the third fragment is reduced with a bone clamp and stabilized with cerclage wiring, followed by antegrade or retrograde intramedullary nailing.

Procedure: Open reduction, cerclage fixation and intramedullary nailing

Closed reduction without exposure of the fracture site, followed by antegrade or retrograde intramedullary nailing.

Open exposure of the fracture site with reduction and cerclage wiring of the third fragment, followed by antegrade or retrograde intramedullary nailing.

Plazo: 6 months postoperatively

Proportion of patients with radiographic union, defined as bridging callus across at least three of four cortices on anteroposterior and lateral radiographs with painless full weight bearing, assessed using the Radiographic Union Score for Femur (RUSF) by two independent reviewers.

Plazo: 6 months postoperatively

Proportion of patients who failed to achieve radiographic union by six months.

Plazo: 9 months postoperatively

Proportion of patients who failed to achieve radiographic union by nine months

Plazo: Intraoperative

Duration of surgery from skin incision to wound closure, in minutes.

Plazo: Intraoperative

Estimated intraoperative blood loss, in millilitres.

Plazo: Up to 9 months postoperatively

Number of patients with postoperative complications, including surgical site infection.

Plazo: 9 months postoperatively

Third-fragment projected area (cm²), measured on preoperative imaging, evaluated for its ability to discriminate delayed union using receiver-operating-characteristic analysis, reported as the area under the curve (AUC).

Plazo: 9 months postoperatively

Third-fragment length (cm), measured on preoperative imaging, evaluated for its ability to discriminate nonunion using receiver-operating-characteristic analysis, reported as the area under the curve (AUC).

Plazo: 9 months postoperatively

Third-fragment displacement (mm), measured on preoperative imaging, evaluated for its ability to discriminate nonunion using receiver-operating-characteristic analysis, reported as the area under the curve (AUC).

Cerclage Fixation of Third Fragment in Femoral Shaft Fracture is That Necessary