Clinical Trials: A Practical Approach

Bone grafts and biomaterials substitutes for bone defect repair: A review.

https://www.ipd.gu.se/digitalAssets/1252/1252566_Artikel_sept_Aina_Lancet_2_.pdf

Adolescent idiopathic scoliosis.

https://www.hand.theclinics.com/article/S0749-0712(12)00002-9/pdf

The Epidemiology of Distal Radius Fractures

Introduction: The Neuromodulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society (INS) evaluated evidence regarding the safety and efficacy of neurostimulation to treat chronic pain, chronic critical limb ischemia, and refractory angina and recommended appropriate clinical applications. Methods: The NACC used literature reviews, expert opinion, clinical experience, and individual research. Authors consulted the Practice Parameters for the Use of Spinal Cord Stimulation in the Treatment of Neuropathic Pain (2006), systematic reviews (1984 to 2013), and prospective and randomized controlled trials (2005 to 2013) identified through PubMed, EMBASE, and Google Scholar. Results: Neurostimulation is relatively safe because of its minimally invasive and reversible characteristics. Comparison with medical management is difficult, as patients considered for neurostimulation have failed conservative management. Unlike alternative therapies, neurostimulation is not associated with medication-related side effects and has enduring effect. Device-related complications are not uncommon; however, the incidence is becoming less frequent as technology progresses and surgical skills improve. Randomized controlled studies support the efficacy of spinal cord stimulation in treating failed back surgery syndrome and complex regional pain syndrome. Similar studies of neurostimulation for peripheral neuropathic pain, postamputation pain, postherpetic neuralgia, and other causes of nerve injury are needed. International guidelines recommend spinal cord stimulation to treat refractory angina; other indications, such as congestive heart failure, are being investigated. Conclusions: Appropriate neurostimulation is safe and effective in some chronic pain conditions. Technological refinements and clinical evidence will continue to expand its use. The NACC seeks to facilitate the efficacy and safety of neurostimulation.

The Appropriate Use of Neurostimulation of the Spinal Cord and Peripheral Nervous System for the Treatment of Chronic Pain and Ischemic Diseases: The Neuromodulation Appropriateness Consensus Committee

Background: During the administration of the oral (Part II) examinations for the American Board of Orthopaedic Surgery over the past nine years, it has been observed that orthopaedic surgeons are opting more often for open treatment as opposed to percutaneous fixation of distal radial fractures. Evidence to support this change in treatment is thought to be deficient. The present study was designed to identify changes in practice patterns regarding operative fixation of distal radial fractures between 1999 and 2007 and to assess the results of those treatments over time.

Methods: As a part of the certification process, Part II candidates submit a six-month case list to the American Board of Orthopaedic Surgery. In the present study, we searched the American Board of Orthopaedic Surgery Part II database to evaluate changes in treatment over time and to identify available outcomes and associated complications of open and percutaneous fixation of distal radial fractures. All distal radial fractures that had been treated surgically over a nine-year period (1999 to 2007) were reviewed. The fractures were categorized according to fixation method with use of surgeon self-reported surgical procedure codes. Comparisons of percentage treatment type by year were made. Utilization was analyzed by geographic region, and open and percutaneous fixation were compared with regard to complications and outcomes as self-reported by candidates during the online application process.

Results: The proportion of fractures that were stabilized with open surgical treatment increased from 42% in 1999 to 81% in 2007 (p < 0.0001). Although the differences were small, surgeon-reported outcomes revealed that a higher percentage of patients who had been managed with percutaneous fixation had no pain and normal function but some deformity as compared with patients who had had open treatment. Patients who had been managed with percutaneous fixation had a higher overall complication rate (14.0% compared with 12.3%; p < 0.006) and a higher rate of infection (5.0% compared with 2.6%; p < 0.0001) than those who had been managed with open treatment. Patients who had had open treatment had a higher rate of nerve palsy and/or injury (2.0% compared with 1.2%; p = 0.001). No other differences in the reported complication rates were found between the two techniques.

Conclusions: A striking shift in fixation strategy for distal radial fractures occurred over the past decade among younger orthopaedic surgeons in the United States. These changes occurred despite a lack of improvement in surgeon-perceived functional outcomes.

Level of Evidence: Therapeutic Level III. See Instructions to Authors for a complete description of levels of evidence.

Fractures of the distal part of the radius. The evolution of practice over time. Where's the evidence?

Background: Irrigation of open fracture wounds is a commonly performed procedure, and irrigation additives have been used in an attempt to reduce the risk of infection. In vitro and animal studies have suggested that irrigation with detergent solution is more effective than irrigation with a solution containing antibiotic additives. This study was performed to compare the efficacy of those two solutions in the treatment of open fractures in humans.

Methods: Adult patients with an open fracture of the lower extremity were prospectively randomized to receive irrigation with either a bacitracin solution or a nonsterile castile soap solution. The patients were followed clinically to assess for the development of infection, healing of the soft-tissue wound, and union of the fracture.

Results: Between 1995 and 2002, 400 patients with a total of 458 open fractures of the lower extremity were entered into the study. One hundred and ninety-two patients were assigned to the bacitracin group (B), and 208 were assigned to the castile soap group (C). Outcomes were available for 171 patients with a total of 199 fractures in group B and 180 patients with a total of 199 fractures in group C. The mean duration of follow-up was 500 days. There was no difference between groups B and C in terms of gender, the Gustilo-Anderson grade of the open fracture, the time between the injury and the irrigation, smoking, or alcohol use. There were significant differences in the mean age (thirty-eight compared with forty-two years, p = 0.01), duration of follow-up (560 compared with 444 days, p = 0.01), prevalence of hypotension (23% compared with 14%, p = 0.04), and duration of treatment with intravenous antibiotics (eleven compared with nine days, p = 0.02). An infection developed at thirty-five (18%) of the 199 fracture sites in group B and at twenty-six (13%) of the 199 fracture sites in group C. This difference was not significant (p = 0.2). Bone-healing was delayed for forty-nine (25%) of the 199 group-B fractures and forty-six (23%) of the 199 group-C fractures (p = 0.72). Wound-healing problems occurred in association with nineteen group-B fractures (9.5%) and eight group-C fractures (4%). This difference was significant (p = 0.03).

Conclusions: Irrigation of open fracture wounds with antibiotic solution offers no advantages over the use of a nonsterile soap solution, and it may increase the risk of wound-healing problems.

Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

Comparison of soap and antibiotic solutions for irrigation of lower-limb open fracture wounds : A prospective, randomized study

BACKGROUND The management of open fractures requires wound irrigation and debridement to remove contaminants, but the effectiveness of various pressures and solutions for irrigation remains controversial. We investigated the effects of castile soap versus normal saline irrigation delivered by means of high, low, or very low irrigation pressure. METHODS In this study with a 2-by-3 factorial design, conducted at 41 clinical centers, we randomly assigned patients who had an open fracture of an extremity to undergo irrigation with one of three irrigation pressures (high pressure [>20 psi], low pressure [5 to 10 psi], or very low pressure [1 to 2 psi]) and one of two irrigation solutions (castile soap or normal saline). The primary end point was reoperation within 12 months after the index surgery for promotion of wound or bone healing or treatment of a wound infection. RESULTS A total of 2551 patients underwent randomization, of whom 2447 were deemed eligible and included in the final analyses. Reoperation occurred in 109 of 826 patients (13.2%) in the high-pressure group, 103 of 809 (12.7%) in the low-pressure group, and 111 of 812 (13.7%) in the very-low-pressure group. Hazard ratios for the three pairwise comparisons were as follows: for low versus high pressure, 0.92 (95% confidence interval [CI], 0.70 to 1.20; P = 0.53), for high versus very low pressure, 1.02 (95% CI, 0.78 to 1.33; P = 0.89), and for low versus very low pressure, 0.93 (95% CI, 0.71 to 1.23; P = 0.62). Reoperation occurred in 182 of 1229 patients (14.8%) in the soap group and in 141 of 1218 (11.6%) in the saline group (hazard ratio, 1.32, 95% CI, 1.06 to 1.66; P = 0.01). CONCLUSIONS The rates of reoperation were similar regardless of irrigation pressure, a finding that indicates that very low pressure is an acceptable, low-cost alternative for the irrigation of open fractures. The reoperation rate was higher in the soap group than in the saline group. (Funded by the Canadian Institutes of Health Research and others; FLOW ClinicalTrials.gov number, NCT00788398.)

/pdf/a-trial-of-wound-irrigation-in-the-initial-management-of-3r9ijb3sqk.pdf

A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds.

Locking plates are fracture fixation devices that allow the insertion of fixed-angle/angular-stable screws or pegs and do not require friction between the plate and bone. The clinical care impetus for the development of these plates has been a combination of factors, including the increasing survival of patients with high-energy injuries, aging Western European and North American populations with an increasing rate of fragility fractures, and dissatisfaction of patients and surgeons with the outcomes of treatment of specific periarticular fractures. Nonclinical factors likely include a push by industry for new technology and new markets as well as the general interest of the public in "minimally invasive" surgery.

Jeffrey O. Anglen

Papers

Fractures of the distal part of the radius. The evolution of practice over time. Where's the evidence?

Comparison of soap and antibiotic solutions for irrigation of lower-limb open fracture wounds : A prospective, randomized study

A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds.

Locking Plates: Tips and Tricks

Distal humerus fractures.