Prospective randomized controlled trial of an intramedullary nail versus dynamic screw and plate for intertrochanteric fractures of the femur

Objectives: To compare the surgical complications and functional outcome of the Gamma nail intramedullary fixation device versus the Richards sliding hip screw and plate device in intertrochanteric femoral fractures. Design: A prospective, randomised controlled clinical trial with observer blinding. Setting: A regional teaching hospital in the United Kingdom. Patients: All patients admitted from the local population with intertrochanteric fractured femurs were included. There were 400 patients entered into the study and 399 followed-up to one year or death. Intervention: The devices were assigned by randomization to either a short-type Gamma nail (203 patients) or a Richard's-type sliding hip screw and plate (197 patients). Main Outcome Measurements: The main surgical outcome measurements were fixation failure and reoperation. A functional outcome of pain, mobility status, and range of movement were assessed until one year. Results: The requirement for revision in the Gamma nail group was twelve (6%), for Richard's group, eight (4%). This was not statistically different (p = 0.29, odds ratio, 1.48 [0.59-3.7]). A subcapital femoral fracture occurred in the Richard's group. Femoral shaft fractures occurred With four in the Gamma nail group (2%) and none in the Richard's group (p = 0.13). Three required revision to another implant. Lag-screw cut-out occurred in eight patients in the gamma nail group (4%) and four in the Richard's group (2%). This was not statistically significant (p = 0.37: odds ratio, 2.29 [0.6-9.0]). The development of other postoperative complications was file same in both groups. There Was no difference between the two groups in terms of early or long-term functional Status at one year. Conclusions: The use of an intramedullary device in the treatment of intertrochanteric femoral fractures is still associated with a higher but non significant risk of postoperative complications. Routine use of the Gamma nail in this type of fracture cannot be recommended over the current standard treatment of dynamic hip screw, and plate.