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 b linding. Setting: A regional teaching hospital in the United Kingdom. Patients: All patients admitted from the local population with intertrochan teric 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 pl ate (197 patients). Main Outcome Measurements: The main surgical outcome measurements were fixa tion 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 occur red in the Richard's group. Femoral shaft fractures occurred With four in t he 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 p atients 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 b oth groups. There Was no difference between the two groups in terms of earl y or long-term functional Status at one year. Conclusions: The use of an intramedullary device in the treatment of intert rochanteric femoral fractures is still associated with a higher but non sig nificant risk of postoperative complications. Routine use of the Gamma nail in this type of fracture cannot be recommended over the current standard t reatment of dynamic hip screw, and plate.