OBJECTIVES: This study aimed at comparing the results obtained with a sliding screw plate and an experimental device including a small-diameter nail that can be placed with a mini-invasive approach and provides a stable fixation. DESIGN: Randomized prospective study. SETTING:University hospital. PATIENTS: The study included two groups with thirty fractures of the trochanteric area. INTERVENTIONS: In both groups, the surgical procedure was carried out on patients placed on a traction table in a supine position, under an x-ray amplifier. Sliding screw plates (THS) were set in place according to the usual open technique. Nails were placed through a twenty-millimeter supratrochanteric cutaneous incision. This experimental system comprised a locked intramedullary nail with two nonparallel seven-millimeter cervicocephalic screws. MAIN OUTCOME MEASURES: The comparison between the two groups was based on the surgical procedure (time, duration of x-ray irradiation, and total blood loss); the initial postoperative period (complications, duration of hospital stay, and the time before returning home); the time before full weight bearing became effective; the functional and social recovery; mortality; and the quality of immediate and final anatomic restitution and healing. RESULTS:Operating time (p < 0.001) and blood loss (p < 0.001) were lower in the nail group, and no blood transfusion was required. Postoperative pain (p < 0.01), time necessary to support full weight bearing (p < 0.02), and time before returning home (p < 0.05) were reduced in the nail group. All fractures healed in the same amount of time, with good anatomic results in the nail group, whereas ten impactions beyond ten millimeters occurred in the plate group. No difference was found between the two groups in walking ability and autonomy recovery, but hip function (p < 0.05) was better in the nail group. CONCLUSION: This preliminary clinical study has shown the advantages of this mini-invasive technique. It could not evaluate all the possible disadvantages inherent in the method. These points will be evaluated in a multicenter study justified by these preliminary results.
RCT Entities:
OBJECTIVES: This study aimed at comparing the results obtained with a sliding screw plate and an experimental device including a small-diameter nail that can be placed with a mini-invasive approach and provides a stable fixation. DESIGN: Randomized prospective study. SETTING: University hospital. PATIENTS: The study included two groups with thirty fractures of the trochanteric area. INTERVENTIONS: In both groups, the surgical procedure was carried out on patients placed on a traction table in a supine position, under an x-ray amplifier. Sliding screw plates (THS) were set in place according to the usual open technique. Nails were placed through a twenty-millimeter supratrochanteric cutaneous incision. This experimental system comprised a locked intramedullary nail with two nonparallel seven-millimeter cervicocephalic screws. MAIN OUTCOME MEASURES: The comparison between the two groups was based on the surgical procedure (time, duration of x-ray irradiation, and total blood loss); the initial postoperative period (complications, duration of hospital stay, and the time before returning home); the time before full weight bearing became effective; the functional and social recovery; mortality; and the quality of immediate and final anatomic restitution and healing. RESULTS: Operating time (p < 0.001) and blood loss (p < 0.001) were lower in the nail group, and no blood transfusion was required. Postoperative pain (p < 0.01), time necessary to support full weight bearing (p < 0.02), and time before returning home (p < 0.05) were reduced in the nail group. All fractures healed in the same amount of time, with good anatomic results in the nail group, whereas ten impactions beyond ten millimeters occurred in the plate group. No difference was found between the two groups in walking ability and autonomy recovery, but hip function (p < 0.05) was better in the nail group. CONCLUSION: This preliminary clinical study has shown the advantages of this mini-invasive technique. It could not evaluate all the possible disadvantages inherent in the method. These points will be evaluated in a multicenter study justified by these preliminary results.
Authors: Casey S Whale; D Andrew Hulet; Michael J Beebe; David L Rothberg; Chong Zhang; Angela P Presson; Ami R Stuart; Erik N Kubiak Journal: Curr Orthop Pract Date: 2016 Nov-Dec
Authors: Sharon R Lewis; Richard Macey; Joseph Lewis; Jamie Stokes; James R Gill; Jonathan A Cook; William Gp Eardley; Martyn J Parker; Xavier L Griffin Journal: Cochrane Database Syst Rev Date: 2022-02-10