A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions. A prospective, randomized study of the management of severe ankle fractures. Internal fixation versus hemiarthroplasty for the displaced subcapital fracture of the femur. A prospective randomised study. Radiographic analysis of fusion progression following one-level cervical fusion with or without plate fixation. Cannulated screws versus hemiarthroplasty for displaced intracapsular femoral neck fractures in demented patients. Extramedullary fixation of 569 unstable intertrochanteric fractures: a randomized multicenter trial of the Medoff sliding plate versus three other screw-plate systems. The effect of voluntary trunk rotation and half-field eye-patching for patients with unilateral neglect in stroke: a randomized controlled trial. A clinical trial investigating the possible effect of the supine cervical rotatory manipulation and the supine lateral break manipulation in the treatment of mechanical neck pain: a pilot study. Internal fixation versus hemiarthroplasty for displaced fractures of the femoral neck in elderly patients with severe cognitive impairment.
A randomized double-blind prospective comparison with a placebo control. This report of the results is the first in an ongoing study.
                To evaluate the effect of noninvasive capacitively coupled electrical stimulation on the success rate of lumbar spine fusion surgery, and to compare active with placebo stimulators as adjuncts to contemporary fusion techniques.
                Previous studies have established the effectiveness of direct current and electromagnetic field stimulation as adjuncts for some forms of spinal fusion. None of the previous placebo-controlled studies on external bone stimulation included posterolateral fusion techniques, and most were conducted with prior generations of internal fixation hardware.
                The investigation was conducted by 28 U.S. surgeons. Patients with a primary diagnosis of degenerative disc disease with or without other degenerative changes were selected. The study protocol defined success as a clinical outcome rated as excellent or good and a fusion documented as solid by both the investigator and the blinded independent radiologist. Disagreements on radiographic success were resolved by a second blinded independent reviewer.
                For the 179 patients who completed treatment and evaluation, the overall protocol success rate (both clinical and radiographic results rated as successes) was 84.7% for the active patients and 64.9% for the placebo patients. This difference is highly significant according to the Yates corrected chi-square test (P = 0.0043). Best improvements in patient outcomes (20% or greater success rate) occurred when active stimulation was used in conjunction with posterolateral fusion (P = 0.006) and when internal fixation also was incorporated (P = 0.013).
                This study was consistent in that active stimulation improved results for each stratification, although some strata had insufficient numbers of patients for the results to have statistical significance. Improved success rates when capacitively coupled stimulation is added to internal fixation are hypothesized to result from overcoming the biochemical effects of stress shielding.
                Capacitively coupled stimulation is an effective adjunct to primary spine fusion, especially for patients with posterolateral fusion and those with internal fixation. One hundred and thirty-eight patients with a closed grade-4 supination-external rotation or pronation-external rotation ankle fracture (Lauge-Hansen classification) who were seen in the emergency room of the University of Chicago Hospitals were entered into a randomized study of the results of various methods of treatment. Ninety-six patients with satisfactory initial closed reduction were randomized between continued closed treatment in a plaster cast and open reduction with rigid internal fixation according to the techniques of the Association for the Study of Internal Fixation (ASIF). Forty-two patients with unsatisfactory closed reduction were randomized between open reduction with internal fixation of only the medial malleolus and open reduction with rigid internal fixation according to the ASIF techniques. Of the 138 patients who were admitted to the study, only seventy-one (51 per cent) could be followed for an average of 3.5 years (a typical return rate of urban trauma centers). The outcomes were evaluated by a scoring system that included clinical, anatomical, and arthritis scores. Statistical analysis of the data showed that, of the patients with initial satisfactory closed reduction, the ones treated by open reduction and rigid internal fixation had significantly higher total scores, particularly the patients who were more than fifty years old and those with a medial malleolar fracture. The small number of patients with unsatisfactory closed reduction who were treated by one of the two types of open reduction and internal fixation and were available for follow-up precluded drawing any conclusions about the superiority of one method of internal fixation over the other in that group. The difference in the talocrural angle between the injured and normal sides was the only statistically significant radiographic indicator of a good prognosis. A prospective randomised trial of surgical treatment for the displaced subcapital femoral fracture in patients of 70 years or more is presented. Two hundred and eighteen patients were randomly allocated into one of three treatment groups: manipulative reduction and internal fixation using Garden screws; Thompson hemiarthroplasty through a posterior (Moore) approach; and Thompson hemiarthroplasty through an anterolateral (McKee) approach. There is no significant difference in the mortality of the internal fixation and posterior arthroplasty groups. Both groups showed a significantly higher mortality than patients operated on through the anterior approach. The technical results of operation were worse in the internally fixed group, with only 40 per cent being satisfactory. Mobilisation was best achieved after the posterior approach. It is concluded that Thompson hemiarthroplasty, using an anterolateral approach, is the safest operation in this group of patients. Anterior cervical discectomy and fusion (ACDF) using bone graft or a cage with plate fixation is an accepted technique for the treatment of symptomatic degenerative disc disease. It is, however, debatable whether a plate is really necessary to increase the progress of fusion. Thus, the aim of this randomized and controlled prospective study was to evaluate whether ACDF with a cage and anterior plate fixation results in a greater progress of fusion compared with ACDF using a stand-alone cage.
                37 candidates for ACDF were treated either with a stand-alone cage (study group) or with a cage+plate fixation (control group). 19 patients were randomized to be stabilized with a stand-alone cage and 18 patients were treated with a cage and additional anterior plate fixation. The progress of cervical fusion over time was compared by radiostereometric analysis (RSA). Follow-up examinations pre- and postoperatively were done using the Visual Analogue Scale (VAS) for neck and arm pain. Radiographic assessment of fusion using an RSA-control was done after one, six and twelve weeks, as well as after six months, and one and two years postoperatively. Mann-Whitney test for unpaired values was used to determine the statistical differences in residual intervertebral motion.
                Three-dimensional analysis of segmental motion (left-right, cranio-caudal, and posterior-anterior) did not reveal any statistical differences between both groups at any examination time postoperatively ( P>0.05). The VAS score did not differ between the groups ( P>0.05).
                Anterior plate fixation did not demonstrate an improvement in the progress of fusion in one-level ACDF. There are no randomised trials comparing internal fixation and hemiarthroplasty for a displaced intracapsular femoral neck fracture in relation to mental state.
                To establish what should be the treatment of first choice, a prospective randomised clinical study was performed on 60 demented patients with displaced intracapsular femoral neck fractures, comparing internal fixation (n = 31) with hemiarthroplasty (n = 29).
                There was no significant difference in the mortality rate of both groups. Hemiarthroplasty was associated with significantly more loss of blood and more wound complications. Reoperation for secondary displacement of the fracture after internal fixation occurred in four patients. Although not-statistically significant, failure of internal fixation seemed to be higher after an inadequate osteosynthesis.
                Postoperative mortality is high and the chance of successful rehabilitation very small for both types of treatment in this group of patients. In our opinion, demented patients should not be treated with a major surgical procedure like hemiarthroplasty. Internal fixation should be considered the treatment of choice, because it is a smaller operation than prosthetic replacement, with less morbidity. If adequate reduction can not be achieved, a primary hemiarthroplasty should be performed. 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. To investigate the effectiveness of voluntary trunk rotation and half-field eye-patching to treat patients with unilateral neglect in stroke.
                Pre-post, day 60 follow-up, single-blinded randomized controlled trial.
                Single-centre inpatient rehabilitation hospital.
                Sixty subacute patients with right hemisphere stroke having unilateral neglect within eight weeks post stroke consented to participate between November 2003 and July 2005. They were randomly assigned to three comparison groups.
                Nineteen patients received daily experimental training in voluntary trunk rotation (TR) for 1 hour five times a week for 30 days. Twenty patients received the same kind of treatment together with half-field eye-patching (TR + EP). Fifteen patients in the control group received conventional training with the same contact time.
                Patients were assessed on days 0, 30 and 60 using the Behavioural Inattention Test, the Clock Drawing Test, and the Functional Independence Measure.
                No significant differences between voluntary trunk rotation (TR), voluntary trunk rotation and half-field eye-patching (TR + EP) and controls were found in functional performance and neglect measures at day 30 (P = 0.042-0.994) and follow-up (P = 0.052-0.911) at P = 0.005 using Bonferroni correction.
                The results of this study do not support the use of voluntary trunk rotation alone or with half-field eye-patching to improve functional performance or reduce unilateral neglect in subacute patients with stroke. To evaluate the possible effect of the supine cervical rotary manipulation and the supine lateral break manipulation in the treatment of mechanical neck pain, according to subjective and objective clinical findings.
                Delivering a supine lateral break manipulation to the ipsilateral side of an inflamed facet joint(s) that exhibits a lateral flexion fixation may result in pain and/or discomfort to the patient. Thus the proposed alternative is a supine cervical rotary manipulation delivered on the ipsilateral side or a supine lateral break manipulation delivered on the contralateral side of the relevant joint(s).
                Randomized, comparative clinical trial.
                Two groups of 15 subjects diagnosed with mechanical neck pain.
                The diagnosis of mechanical neck pain and the identification of lateral flexion fixations in the cervical spine were made with conventional clinical evaluation, including motion palpation. Group A received a cervical rotary manipulation(s) on the ipsilateral side of the lateral flexion fixation(s), while group B received a supine lateral break manipulation(s) on the contralateral side of the lateral flexion fixation(s). Subjects received a maximum of 10 treatments over a 4-week treatment period. Outcome Measures: Both treatment groups were assessed with subjective (Numerical Pain Rating Scale 101, McGill Short-Form Pain Questionnaire and the Canadian Memorial Chiropractic College Neck Disability Index) and objective (cervical range of motion goniometer and algometer) measurement parameters at the initial consultation (before any treatment), the final consultation, and at a 1-month follow-up consultation. Statistical analysis was conducted at a 95% confidence level (alpha =.05) with the non-parametric 2-tailed Wilcoxon signed ranks test, the Mann-Whitney U test, and descriptive statistics. Two-tailed power analysis was conducted after the fact, where a confidence level of 80% (beta =.20) was considered satisfactory.
                Intragroup analysis indicated a significant difference between the initial consultation data and the final consultation data for the subjective data, indicating an effect. Analysis of the objective data did not reveal any significant difference. Intergroup analysis did not reveal any significant difference between the 2 groups when comparing the data of the initial consultation and the final consultation, indicating that both treatments had a similar or equal effect. Power analysis was not satisfactory for most data, indicating the possibility of many Type II errors.
                Statistically, the results suggested that both treatments had an effect but that neither group showed a benefit over the other. However, because of the unsatisfactory power of the study, conclusions are to be drawn with caution. Clinical significance supported the statistical outcomes where it was suggested that both treatments had an effect and that neither treatment had a greater effect. A larger sample size and the inclusion of a placebo group is recommended to reveal true treatment outcomes and trends. We studied 60 patients with an acute displaced fracture of the femoral neck and with a mean age of 84 years. They were randomly allocated to treatment by either internal fixation with cannulated screws or hemiarthroplasty using an uncemented Austin Moore prosthesis. All patients had severe cognitive impairment, but all were able to walk independently before the fracture. They were reviewed at four, 12 and 24 months after surgery. Outcome assessments included complications, revision surgery, the status of activities of daily living (ADL), hip function according to the Charnley score and the health-related quality of life (HRQOL) according to the Euroqol (EQ-5D) (proxy report). General complications and the rate of mortality at two years (42%) did not differ between the groups. The rate of hip complications was 30% in the internal fixation group and 23% in the hemiarthroplasty group; this was not significant. There was a trend towards an increased number of re-operated patients in the internal fixation group compared with the hemiarthroplasty group, 33% and 13%, respectively (p = 0.067), but the total number of surgical procedures which were required did not differ between the groups. Of the survivors at two years, 54% were totally dependent in ADL functions and 60% were bedridden or wheelchair-bound regardless of the surgical procedure. There was a trend towards decreased mobility in the hemiarthroplasty group (p = 0.066). All patients had a very low HRQOL even before the fracture. The EQ-5D(index) score was significantly worse in the hemiarthroplasty group compared with the internal fixation group at the final follow-up (p < 0.001). In our opinion, there is little to recommend hemiarthroplasty with an uncemented Austin Moore prosthesis compared with internal fixation, in patients with severe cognitive dysfunction.
There is insufficient robust evidence to determine the relative effects of different methods of external fixation. Adequately powered studies could provide better evidence.