Extramedullary fixation of 569 unstable intertrochanteric fractures: a randomized multicenter trial of the Medoff sliding plate versus three other screw-plate systems. Treatment of reverse oblique and transverse intertrochanteric fractures with use of an intramedullary nail or a 95 degrees screw-plate: a prospective, randomized study. Extramedullary fixation of 107 subtrochanteric fractures: a randomized multicenter trial of the Medoff sliding plate versus 3 other screw-plate systems. Prospective randomized controlled trial of an intramedullary nail versus dynamic screw and plate for intertrochanteric fractures of the femur. Intertrochanteric fractures: a comparison between fixation with a two-piece nail plate and Ender's nails. Intramedullary nailing versus fixed angle blade plating for subtrochanteric femoral fractures: a prospective randomised controlled trial. Treatment of intertrochanteric fractures: comparison of Ender nails and sliding screw plates. [The gamma-nail as a resilient alternative to the dynamic hip screw in unstable proximal femoral fractures in the elderly]. Treatment of intertrochanteric fracture with the Gamma AP locking nail or by a compression hip screw--a randomised prospective trial. The standard Gamma nail or the Medoff sliding plate for unstable trochanteric and subtrochanteric fractures. A randomised, controlled trial. A prospective trial comparing the Holland nail with the dynamic hip screw in the treatment of intertrochanteric fractures of the hip. Prospective randomized comparison of gliding nail and gamma nail in the therapy of trochanteric fractures. Fixation of intertrochanteric fractures of the femur. A randomised prospective comparison of the gamma nail and the dynamic hip screw. [Classic nail versus DHS. A prospective randomised study of fixation of trochanteric femur fractures]. Prospective randomized comparison between a dynamic hip screw and a mini-invasive static nail in fractures of the trochanteric area: preliminary results.
We compared the efficacy of the Medoff sliding plate (MSP) with 3 other screw-plate systems for fixation of unstable intertrochanteric fractures in a randomized multicenter trial of 569 elderly patients. The MSP has biaxial dynamic capacity along both the neck and the shaft of the femur unlike the other systems, which lack dynamic capacity along the shaft. 268 fractures were operated on with the MSP, and 301 with the dynamic hip screw (DHS), with or without a trochanteric stabilizing plate (DHS/TSP) or with the dynamic condylar screw (DCS). The MSP had recently been shown to the surgeons. The patients in the groups were similar as regards age, domestic situation, preinjury walking ability and type of fracture. We followed the patients clinically and radiographically for at least 1 year. There was no significant difference in walking ability at follow-up or rate of return to home. Fixation failure occurred in 18/268 fractures operated on with the MSP, in 8/238 with the DHS, in 3/49 with the DHS/TSP and in 1/14 with the DCS. The difference in the rate of fixation failure was not statistically significant when the MSP group was compared to the 3 other groups. In 14 of the 18 fixation failures in the MSP group, the biaxial dynamic capacity of the MSP had not been used due to technical errors by surgeons, unfamiliar with the new method. No selection bias was found regarding fracture types in the 2 subgroups of patients with correct or inadequate biaxial dynamization. Extramedullary fixation of unstable intertrochanteric fractures with these implants showed a low failure rate. When using the MSP, biaxial dynamization must be correctly performed. Intertrochanteric fractures are composed of different anatomic patterns that vary in their degree of stability following open reduction and internal fixation. A particularly unstable group is classified as AO/OTA 31-A3, with the fracture pattern described as reverse oblique or transverse. The purpose of this study was to compare the results of intramedullary fixation with those of plate fixation for these intertrochanteric fractures in elderly patients.
                Thirty-nine elderly patients with AO/OTA 31-A3 intertrochanteric fractures of the femur were randomized into two treatment groups and were followed for a minimum of one year. The nineteen patients in Group I were treated with a 95 fixed-angle screw-plate (Dynamic Condylar Screw), and the twenty patients in Group II were treated with an intramedullary nail (Proximal Femoral Nail). The treatment groups were comparable with regard to all demographic and injury variables.
                Patients treated with an intramedullary nail had shorter operative times, fewer blood transfusions, and shorter hospital stays compared with those treated with a 95 screw-plate. Implant failure and/or nonunion was noted in seven of the nineteen patients who had been treated with the 95 screw-plate. Only one of the twenty fractures that had been treated with an intramedullary nail did not heal.
                The results of our study support the use of an intramedullary nail rather than a 95 screw-plate for the fixation of reverse oblique and transverse intertrochanteric fractures in elderly patients. We compared the efficacy of a load-sharing device, the Medoff sliding plate (MSP), with that of 3 other load-bearing screw-plate devices for the fixation of subtrochanteric fractures in a randomized multicenter trial of 107 elderly patients. 55 fractures were operated on with the MSP, and 52 with the dynamic hip screw (DHS) with or without a trochanteric stabilizing plate (TSP) or with the dynamic condylar screw (DCS). The patient material in the groups was similar regarding age, domestic situation, preinjury walking ability and fracture types. We followed the patients clinically and radiographically for a minimum of 1 year. There was no significant difference in walking ability or return rate to the home at follow-up. Fixation failure occurred in 1/55 fractures operated on with the MSP, in 3/32 with the DHS, in 3/12 with the DCS and in 2/8 with the DHS/TSR The difference in the rate of fixation failure was statistically significant, when the MSP group was compared to the 3 load-bearing devices in the other group (1 vs 8). On the basis of this experience, we think that the load-sharing principle of the MSP, which seems to facilitate fracture impaction and stability, appears to be a good alternative in extramedullary fixation of subtrochanteric fractures. 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.
                A prospective, randomised controlled clinical trial with observer blinding.
                A regional teaching hospital in the United Kingdom.
                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.
                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).
                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.
                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 the same in both groups. There was no difference between the two groups in terms of early or long-term functional status at one year.
                The use of an intramedullary device in the treatment of intertrochanteric femoral fractures is still associated with a higher but nonsignificant 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. The progress of 182 patients who presented with intertrochanteric fractures was followed over a six month period. Eighty-seven patients were treated using Thornton/McLaughlin nail plates and 95 were treated using Ender's intramedullary nails. Each fracture was classified according to radiological position and mechanical stability. The results show that the more unstable fractures are more likely to develop unsatisfactory results. Post operatively, the different mechanical complications have been recorded at various stages. Those fractures fixed with a nail plate tended to develop varus deformity resulting from either bony collapse around the implant or implant failure, whereas those fixed with Ender's nails did not develop deformity at the fracture site but encountered distal migration of the nails at the knee. The use of a classification system in predicting post operative mechanical complications is considered, and the comparative merits and disadvantages of the two fixation systems is discussed, with suggestions for improvement in operative technique. To compare closed intramedullary nailing to open reduction and internal fixation using a fixed angle blade plate for the management of subtrochanteric femoral fractures.
                58 patients were equally randomised to undergo either an intramedullary nailing (IN) or fixed angle blade plating (BP).
                There were no significant differences between the 2 groups with regard to age, time to surgery, operating time, receipt of blood transfusions, duration of hospital stay, or fracture classification. The revision rate was 28% (8/29) in the BP group and none in the IN group; the difference was statistically significant.
                Internal fixation using a fixed angle blade plate for subtrochanteric femoral fractures has higher implant failure and revision rates, compared to closed intramedullary nailing. The results of two fixation devices for the treatment of intertrochanteric fractures were compared in 220 patients--163 women and 57 men with a mean age of 81 +/- 10 years. One hundred and one patients were randomized to Ender nailing and 119 to fixation with a sliding screw plate (SSP). The two treatment groups were equal with respect to important preinjury variables. The two methods did not differ in operating time or perioperative blood loss. The proportions of good reduction of the fractures and of good positioning of the internal fixation devices were equal in the two groups. But the complication rate and the reoperation rate were more than twice as high in the Ender group than in the SSP group. The outcome at 1-year follow-up was approximately equal in the two groups. In a prospective randomised trial between September 1989 and June 1990 one hundred patients with per- and subtrochanteric fractures were consecutively treated by gamma-nail or DHS. The average age of both groups was about 80 years. The operation time for gamma-nailing was longer than for DHS implantation and also the postoperative blood loss was higher in the gamma-nail group. We found no difference of intraoperative blood loss, of perioperative lethality and in duration of hospital care. 90% of gamma-nail patients and 80% of DHS patients were successfully able to walk four days after operation with full weight bearing on the operated limb. Three patients in the DHS group with unstable fractures got cranial perforation of the cephalic screw mobilisation. Five patients of the gamma-nail group were reoperated, one case because of missed distal locking, one because of cranial perforation of the cephalic screw after varus dislocation of the proximal fragment. One patient suffered intraoperatively a proximal femur shaft fracture which was corrected during operation. In one case a wound hematoma was evacuated, an other patient needed secondary wound closure. Despite technical imperfection of implant and instruments, we conclude that the gamma-nail allows a very high percentage early and full weight bearing immediately after operation. So we consider that in the treatment of unstable pertrochanteric fractures of geriatric patients, the gamma-nail has proven to be more efficient than the DHS. The Gamma AP (Asia-Pacific) locking nail (GAPN) is a modification of the standard Gamma locking nail made especially for use in Oriental patients. We made a randomised prospective comparison of the compression hip screw (CHS) and the Gamma AP locking nail for the internal fixation of 60 intertrochanteric fractures of the hip in elderly patients by comparing perioperative details and analysing the radiographic and clinical results. The operation time for the GAPN group was shorter than for the CHS group and the intraoperative blood loss was lower. The Gamma AP nail enabled earlier mobilisation. We found no significant difference in the time to union and the length of sliding of the lag screw between the two groups. The decrease in the neck shaft angle in the Gamma nail group was significantly smaller than in the CHS patients. There were no significant mechanical complications, such as fracture of the femoral shaft or failure of fixation in the Gamma nail group. On the basis of our observations we conclude that the Gamma AP locking nail is more efficient than the CHS in the treatment of intertrochanteric fractures in geriatric patients. We studied 217 patients with an unstable trochanteric or subtrochanteric fracture who had been randomly allocated to treatment by either internal fixation with a standard Gamma nail (SGN) or a Medoff sliding plate (MSP, biaxial dynamisation mode). Their mean age was 84 years (65 to 99) and they were reviewed at four and 12 months after surgery. Assessments of outcome included general complications, technical failures, revision surgery, activities of daily living (ADL), hip function (Charnley score) and the health-related quality of life (HRQOL, EQ-5D). The rate of technical failure in patients with unstable trochanteric fractures was 6.5% (6/93) (including intra-operative femoral fractures) in the SGN group and 5.2% (5/96) in the MSP group. In patients with subtrochanteric fractures, there were no failures in the SGN group (n = 16) and two in the MSP group (n = 12). In the SGN group, there were intra-operative femoral fractures in 2.8% (3/109) and no post-operative fractures. There was a reduced need for revision surgery in the SGN group compared with the MSP group (8.3%; 9/108; p = 0.072). The SGN group also showed a lower incidence of severe general complications (p < 0.05) and a trend towards a lower incidence of wound infections (p = 0.05). There were no differences between the groups regarding the outcome of ADL, hip function or the HRQOL. The reduction in the HRQOL (EQ-5D(index) score) was significant in both groups compared with that before the fracture (p < 0.005). Our findings indicate that the SGN showed good results in both trochanteric and subtrochanteric fractures. The limited number of intra-operative femoral fractures did not influence the outcome or the need for revision surgery. Moreover, the SGN group had a reduced number of serious general complications and wound infections compared with the MSP group. The MSP in the biaxial dynamisation mode had a low rate of failure in trochanteric fractures but an unacceptably high rate when used in the biaxial dynamisation mode in subtrochanteric fractures. The negative influence of an unstable trochanteric or subtrochanteric fracture on the quality of life was significant regardless of the surgical method. We compared the outcome of patients treated for an intertrochanteric fracture of the femoral neck with a locked, long intramedullary nail with those treated with a dynamic hip screw (DHS) in a prospective randomised study. Each patient who presented with an extra-capsular hip fracture was randomised to operative stabilisation with either a long intramedullary Holland nail or a DHS. We treated 92 patients with a Holland nail and 98 with a DHS. Pre-operative variables included the Mini Mental test score, patient mobility, fracture pattern and American Society of Anesthesiologists grading. Peri-operative variables were anaesthetic time, operating time, radiation time and blood loss. Post-operative variables were time to mobilising with a frame, wound infection, time to discharge, time to fracture union, and mortality. We found no significant difference in the pre-operative variables. The mean anaesthetic and operation times were shorter in the DHS group than in the Holland nail group (29.7 vs 40.4 minutes, p < 0.001; and 40.3 vs 54 minutes, p < 0.001, respectively). There was an increased mean blood loss within the DHS group versus the Holland nail group (160 ml vs 78 ml, respectively, p < 0.001). The mean time to mobilisation with a frame was shorter in the Holland nail group (DHS 4.3 days, Holland nail 3.6 days, p = 0.012). More patients needed a post-operative blood transfusion in the DHS group (23 vs seven, p = 0.003) and the mean radiation time was shorter in this group (DHS 0.9 minutes vs Holland nail 1.56 minutes, p < 0.001). The screw of the DHS cut out in two patients, one of whom underwent revision to a Holland nail. There were no revisions in the Holland nail group. All fractures in both groups were united when followed up after one year. We conclude that the DHS can be implanted more quickly and with less exposure to radiation than the Holland nail. However, the resultant blood loss and need for transfusion is greater. The Holland nail allows patients to mobilise faster and to a greater extent. We have therefore adopted the Holland nail as our preferred method of treating intertrochanteric fractures of the hip. In a prospective randomized study, we compared the new intramedullary implant of the gliding nail to the gamma nail in the fixation of 80 unstable trochanteric fractures in elderly patients. The preconditions of both groups were comparable. We found no differences concerning the operation time, blood loss, period of stationary treatment or social situation. Also, the anatomic reconstruction and the long-term function according to the Merle d'Aubigne score were comparable. Regarding postoperative complications, the gliding nail showed a minor tendency of cutting out; this we attribute to the special design of the dynamic blade and regard it as the most favourable advantage of this new implant. We have prospectively compared the fixation of 100 intertrochanteric fractures of the proximal femur in elderly patients with random use of either a Dynamic Hip Screw (DHS) or a new intramedullary device, the Gamma nail. We found no difference in operating time, blood loss, wound complications, stay in hospital, place of eventual discharge, or the patients' mobility at final review. There was no difference in failure of proximal fixation: cut-out occurred in three cases with the DHS, and twice with the Gamma nail. However, in four cases fracture of the femur occurred close to the Gamma nail, requiring further major surgery. In the absence of these complications, union was seen by six months in both groups. The intramedullary hip screw system Classic-Nail and the Dynamic Hip Screw (DHS) were evaluated in a prospective-randomized clinical trial for operative treatment of trochanteric femur fractures. Hundred and ten geriatric patients (mean age 82 years) were runningly included in the study (56 Classic Nail, 54 DHS). No significant differences between the two study groups were observed with regard to treatment and follow-up data. With the Classic-Nail one complete femur shaft fracture and one incomplete fracture occurred at the tip of the nail intraoperatively and could successfully be fixed with cerclage wires. In the DHS group two patients underwent reoperation for significant loss of reduction early postoperatively. At an average follow-up of 3.7 months all fractures were healed with no difference in functional outcome between the two groups.--Classic Nail and DHS both lead to equally good results in the operative treatment of trochanteric femur fractures. 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.
                Randomized prospective study.
                University hospital.
                The study included two groups with thirty fractures of the trochanteric area.
                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.
                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.
                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.
                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.
The markedly increased fixation failure rate of fixed nail plates compared with the SHS is a major consideration and thus the SHS appears preferable.
There was insufficient evidence from other comparisons of extramedullary implants or on the use of external fixators to draw definite conclusions.