The Effect of Product Safety Courses on the Adoption and Outcomes of LESS Surgery.

BACKGROUND AND OBJECTIVES: As technology in surgery evolves, the medical instrument industry is inevitability involved in promoting the use and appropriate (ie, effective and safe) application of its products. This study was undertaken to evaluate industry-supported product safety courses in laparoendoscopic single-site (LESS) surgery, by using the metrics of surgeons' adoption of the technique, safety of the procedure, and surgeons' perception of the surgery. METHODS: LESS surgery courses that involved didactic lectures, operative videos, operation observation, collaborative learning, and simulation, were attended by 226 surgeons. With Florida Hospital Tampa Institutional Review Board approval, the surgeons were queried before and immediately after the course, to assess their attitudes toward LESS surgery. Then, well after the course, the surgeons were contacted, repeatedly if necessary, to complete questionnaires. RESULTS: Before the course, 82% of the surgeons undertook more than 10 laparoscopic operations per month. Immediately after the course, 86% were confident that they were prepared to perform LESS surgery. Months after the course, 77% of the respondents had adopted LESS surgery, primarily cholecystectomy; 59% had added 1 or more trocars in 0-20% of their procedures; and 73% held the opinion that operating room observation was the most helpful learning experience. Complications with LESS surgery were noted 12% of the time. Advantages of the technique were better cosmesis (58%) and patient satisfaction (38%). Disadvantages included risk of complications (37%) and higher technical demand (25%). Seventy-eight percent viewed LESS surgery as an advancement in surgical technique. CONCLUSION: In multifaceted product safety courses, operating room observation is thought to provide the most helpful instruction for those wanting to undertake LESS surgery. The procedure has been safely adopted by surgeons who frequently perform laparoscopies. The tradeoff is in performing a more difficult technique to obtain better cosmesis for the patient. We must continue to conduct critical evaluations of product safety courses for the introduction of new technology in surgery.

The learning curve of laparoendoscopic single-Site (LESS) fundoplication: definable, short, and safe.

BACKGROUND AND OBJECTIVES: This study of laparoendoscopic single-site (LESS) fundoplication for gastroesophageal reflux disease was undertaken to determine the "learning curve" for implementing LESS fundoplication. METHODS: One hundred patients, 38% men, with a median age of 61 years and median body mass index of 26 kg/m(2) , underwent LESS fundoplications. The operative times, placement of additional trocars, conversions to "open" operations, and complications were compared among patient quartiles to establish a learning curve. Median data are reported. RESULTS: The median operative times and complications did not differ among 25-patient cohorts. Additional trocars were placed in 27% of patients, 67% of whom were in the first 25-patient cohort. Patients undergoing LESS fundoplication had a dramatic relief in the frequency and severity of all symptoms of reflux across all cohorts equally (P < .05), particularly for heartburn and regurgitation, without causing dysphagia. CONCLUSION: LESS fundoplication ameliorates symptoms of gastroesophageal reflux disease without apparent scarring. Notably, few operations required additional trocars after the first 25-patient cohort. Patient selection became more inclusive (eg, more "redo" fundoplications) with increasing experience, whereas operative times and complications remained relatively unchanged. The learning curve of LESS fundoplication is definable, short, and safe. We believe that patients will seek LESS fundoplication because of the efficacy and superior cosmetic outcomes; surgeons will need to meet this demand.

Anteroinferior 2.7-mm versus 3.5-mm plating for AO/OTA type B clavicle fractures: a comparative cohort clinical outcomes study.

OBJECTIVES: To compare the Disability of the Arm, Shoulder, and Hand (DASH) and Constant scores, time to union, rate of union, patient cosmetic satisfaction rate, and the need for secondary procedures between 2.7- and 3.5-mm anteroinferior plating for Arbeitsgemeinschaft für Osteosynthesefragen (AO)/Orthopaedic Trauma Association (OTA) type B clavicle fractures. DESIGN: Retrospective, comparative cohort clinical outcomes study. SETTING: Level I university trauma center. PATIENTS/PARTICIPATION: Thirty-seven patients with an AO/OTA type B clavicle fracture who underwent open reduction internal fixation with either a 2.7- or 3.5-mm reconstruction plate placed in the anterior-inferior position. The main outcome comparisons included DASH score, Constant score, time to union, rate of union, rate of hardware failure, cosmetic satisfaction, and secondary procedure. MAIN OUTCOME MEASUREMENT: DASH score, constant score, time to union, rate of union, cosmetic satisfaction, secondary procedure. RESULTS: At 1-year follow-up, analysis yielded no significant differences in DASH scores (P = 0.26) and Constant Shoulder scores (P = 0.79) between the 2 cohorts. There were no statistically significant differences in the time to union (P = 0.86) and the rate of union (P = 0.49). Although the 2.7-mm cohort had a lower reoperation rate, it was not statistically significant (P = 0.11). However, the 2.7-mm cohort did demonstrate a significantly higher rate of cosmetically acceptable reconstruction (P = 0.003). CONCLUSIONS: Compared with 3.5-mm anterior-inferior plating, 2.7-mm anteroinferior plating for AO/OTA type B clavicle fractures leads to significantly higher rates of cosmetic acceptability while reducing the need for a secondary procedure and achieving excellent clinical outcomes as measured by the DASH and Constant scores. There were no differences between the 2.7 and 3.5 cohorts in time to union or in union rate. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Comparison of mini-open versus arthroscopic harvesting of osteochondral autografts in the knee: a cadaveric study.

PURPOSE: To prove that the assessment of osteochondral graft perpendicularity with magnetic resonance imaging (MRI) will allow for a precise measurement of graft perpendicularity and for an improved comparison of arthroscopic versus mini-open harvest techniques. METHODS: Ten fresh cadaveric knees (mean age, 39.4 years) underwent harvest of 6-mm osteochondral plugs using the Osteochondral Autograft Transfer System (OATS; Arthrex, Naples, FL). A total of 8 plugs were harvested per knee from 3 donor sites: the lateral supracondylar ridge, the medial supracondylar ridge, and the lateral intercondylar notch. Two surgeons performed the graft harvest, alternating between mini-open (5 specimens) and arthroscopic (5 specimens) techniques to minimize bias. The osteochondral plugs were labeled and plated by a novel agar plating technique and then underwent MRI for measurement of graft perpendicularity. The data were analyzed to look for a significant difference in perpendicularity between the 2 harvest techniques, as well as overall graft acceptability. RESULTS: One specimen in the open harvest technique group was unable to undergo optimal MRI because of difficulties encountered with the novel agar plating system resulting in graft movement during imaging. When we compared the mini-open and arthroscopic harvest techniques, the mean angle of perpendicularity at the lateral intercondylar notch harvest site was 84.1° and 84.2°, respectively (P = .958). At the medial supracondylar ridge harvest site, the mean angle of perpendicularity for the mini-open and arthroscopic techniques was 88.4° and 81.0°, respectively, with a mean difference of 7.4° (P = .006). At the lateral supracondylar ridge harvest site, the mean angle of perpendicularity for the mini-open and arthroscopic techniques was 85.7° and 87.1°, respectively (P = .237). CONCLUSIONS: A significant difference in osteochondral autograft perpendicularity was noted at the medial supracondylar ridge when we compared the mini-open and arthroscopic harvesting techniques. This suggests that when one is harvesting autologous osteochondral grafts from the medial supracondylar ridge, the mini-open technique may be preferred. CLINICAL RELEVANCE: When harvesting autologous osteochondral grafts from the medial supracondylar ridge of the knee, the mini-open technique will potentially allow for a more perpendicular graft for implantation.

Consensus statement of the consortium for LESS cholecystectomy.

Many surgeons attempting Laparo-Endoscopic Single Site (LESS) cholecystectomy have found the operation difficult, which is inconsistent with our experience. This article is an attempt to promote a standardized approach that we feel surgeons with laparoscopic skills can perform safely and efficiently. This is a four-trocar approach consistent with the four incisions utilized in conventional laparoscopic cholecystectomy. After administration of general anesthesia, marcaine is injected at the umbilicus and a 12-mm vertical incision is made through the already existing anatomical scar of the umbilicus. A single four-trocar port is inserted. A 5-mm deflectable-tip laparoscope is placed through the trocar at the 8 o'clock position, a bariatric length rigid grasper is inserted through the trocar at the 4 o'clock position (to grasp the fundus), and a rigid bent grasper is placed through the 10-mm port (to grasp the infundibulum). This arrangement of the instruments promotes minimal internal and external instrument clashing with simultaneous optimization of the operative view. This orientation allows retraction of the gallbladder in a cephalad and lateral direction, development of a window between the gallbladder and the liver which promotes the "critical view" of the cystic duct and artery, and provides triangulation with excellent visualization of the operative field. The operation is concluded with diaphragmatic irrigation of marcaine solution to minimize postoperative pain. Standardization of LESS cholecystectomy will speed adoption, reduce intraoperative complications, and improve the efficiency and safety of the approach.

Readmissions after pancreaticoduodenectomy: efforts need to focus on patient expectations and nonhospital medical care.

Readmissions after operations are a burden. This study was undertaken to determine factors predicting readmissions after pancreaticoduodenectomy. Since 1991, patients undergoing pancreaticoduodenectomy have been prospectively followed. Nineteen per cent of 913 patients were readmitted within 30 days after discharge from pancreaticoduodenectomy. The causes for readmissions were reviewed. Median data are presented. All patients had preoperative comorbidities; most common were cardiovascular (26%), gastrointestinal (23%), or endocrine (15%). Twenty-nine per cent had extended pancreaticoduodenectomy, including major vascular resections. The most common reasons for readmission were: nausea/vomiting (26%), wound infection (15%), and abdominal pain (18%). Gender, body mass index, duration of operation, blood loss, length of stay, pathology, American Joint Committee on Cancer™ stage, and margin status did not predict readmission. Patients being readmitted were younger (65 vs 69 years, P < 0.001) and had more comorbidities (P < 0.001). Readmission did not curtail long-term survival. Pancreaticoduodenectomy is a complex operation undertaken in patients with notable comorbidities. Readmissions occur frequently after pancreaticoduodenectomy and patients with more comorbidities are at particular risk. Readmissions are not generally the result of complications specific to pancreaticoduodenectomy, but seem more related to ill health, inaccessible nonhospital medical care, and poor expectations. Efforts must focus on patient expectations, intermediate care, home health care, and improving medical care after discharge.

Identification of the radial nerve during the posterior approach to the humerus: a cadaveric study.

OBJECTIVE: Identification of the radial nerve is necessary during the posterior approach to the humerus in an effort to maintain its integrity. Other than anatomic descriptions of the radial nerve with respect to osseous structures, there are few superficial intraoperative landmarks along the course of the traditional triceps-splitting approach to provide facile nerve identification. The objective of this study was to determine the reliability of using the anatomic intersection of the long and lateral heads of the triceps and the triceps aponeurosis as a superficial reference point for radial nerve identification during the posterior approach to the humerus. METHODS: Thirty adult human cadaver upper extremities as 15 matched pairs were used. Systematic identification and measurement from the point of intersection between the long and lateral heads of the triceps and the triceps aponeurosis to the distal most aspect of the radial nerve as it coursed the posterior humerus at its midaxial point was performed and recorded. RESULTS: Mean distance was found to measure 39.0 ± 2.1 mm (range, 36-44 mm), approximating a fixed distance, two finger breadths proximal to our identified point of intersection. Statistical analysis between the two matched pair groups yielded no significant difference in measured distances (P = 0.88). CONCLUSIONS: Our group has identified the point of intersection among three landmarks forming a point of intersection. This point is the confluence of the long and lateral heads of the triceps and the triceps aponeurosis. This serves as a visualized anatomic reference point during the posterior surgical exposure to the humerus and can be used to identify the radial nerve as it courses the posterior humerus.

Use of an "antibiotic plate" for infected periprosthetic fracture in total hip arthroplasty.

Periprosthetic fracture and infection are dreaded complications after total hip arthroplasty. We present the case of a 50-year-old man who suffered an early postoperative Vancouver B1 periprosthetic fracture, which was further complicated by concurrent infection after open reduction and internal fixation. We report the novel use of an antibiotic-impregnated cement coated locking plate during the staged treatment of concomitant periprosthetic fracture and chronic total hip arthroplasty infection. At 1-year follow-up, the patient is pain free and ambulating independently with full range of motion.

Forward progression of the helical blade into the pelvis after repair with the Trochanter Fixation Nail (TFN).

Unstable intertrochanteric and subtrochanteric fractures historically have been prone to inferior displacement of the femoral head as well as varus collapse. Efforts to mitigate these untoward outcomes have led to the evolution of the Trochanteric Fixation Nail (TFN) with its helical spiral blade. The TFN has many proposed advantages such as simplified insertion, less hardware, and improved resistance to "cutout" of cephallomedullary fixation. Previous case reports have shown spiral blade perforation through the femoral head and, in some cases, into the hip. However, to our knowledge, there have not been any reports describing the advancement of the helical spiral blade into the pelvic cavity. We present a case of forward advancement of the helical spiral blade through the femoral head and acetabulum into the pelvic cavity.

Foreign-body reaction to the Artelon CMC joint spacer: case report.

The Artelon CMC spacer (Small Bone Innovations, Inc., Morrisville, PA) is a relatively new device that was developed for the treatment of basal joint arthritis. It is composed of a biodegradable polycaprolactone-based polyurethane urea that acts to resurface the distal part of the trapezium and stabilize the trapeziometacarpal joint by augmenting the joint capsule. This is a case report of a foreign-body tissue reaction to the Artelon CMC spacer.

Hemicondylar hamate replacement arthroplasty for proximal interphalangeal joint fracture dislocations: an assessment of graft suitability.

PURPOSE: Proximal interphalangeal (PIP) joint fracture-dislocations are complex injuries, and successful surgical treatment can be challenging. The hamate appears to be an appropriate graft based on its general shape and dimensions. The purpose of this study was to evaluate the rationale and suitability of the hamate as an autograft for proximal interphalangeal joint fracture-dislocations and to determine the inherent stability of the donor site after graft harvesting. METHODS: Fresh-frozen cadaveric hand specimens were used to evaluate the hamate as a suitable graft source for defects of the middle phalanx based on macroscopic, radiographic, and biomechanical properties. Radiographic measurements were made of the articular contours of the hamate and the base of middle phalanx of digits 2 through 5. Hemicondylar hamate replacement arthroplasty (HHRA) was performed in cadavers for defects created in the middle phalanges. Biomechanical stability testing of the hamate-metacarpal joint was then assessed in additional specimens before and after HHRA. Fluoroscopic examination with a 22.2-N load applied in a 45 degrees dorsal-proximal direction was used to assess stability of the carpometacarpal joints. A servohydraulic testing machine was then used to determine the amount of translation induced with a similarly directed force before and after harvesting of the hamate graft. RESULTS: The cadaveric HHRA reconstructions restored joint stability with no tendency to subluxate. Radiographic measurement showed that the hamate has a central ridge and bicondylar facet with articular contours that are similar to the base of the middle phalanx. The removal of a central portion of the hamate did not induce dislocation or create obvious clinical instability of the carpometacarpal joint. CONCLUSIONS: The HHRA technique is used for treatment of fracture-dislocations of the proximal interphalangeal joint. This study demonstrated the suitability of using the dorsal portion of the hamate as an osteochondral autograft for middle phalangeal base fractures; the technique creates minimal donor site morbidity.

The effect of circular external fixation on limb alignment.

INTRODUCTION: A full-length standing radiograph of the entire lower extremity is the standard imaging modality for assessing lower limb alignment. However, the effect of an overlying circular external fixator on the radiographic alignment of the lower extremity is not well documented. METHODS: After correction of angular deformity using a circular external fixator, 29 patients (31 limbs) underwent 2 sets of full-length standing radiographs, one done before, and the other, after removal of the fixator. The difference in the measurement of frontal plane alignment, limb lengths, and rotation between the 2 radiographs was analyzed. RESULTS: The mean absolute difference in the measurement of mechanical axis deviation (MAD) between the 2 radiographs was 11.5 mm (P < 0.0001) for the ipsilateral limb (with the external fixator) and 8.9 mm (P < 0.0001) for the contralateral limb. The mean difference in the radiographic measurement of limb lengths was 20 mm (P < 0.0001) for the ipsilateral and 20.2 mm (P < 0.0001) for the contralateral limb. As the magnitude of MAD and external rotation of the ipsilateral limb increased, a progressive increase in the magnitude of discrepancy in the measurement of MAD between the 2 sets of radiographs was noted. There was no significant effect (P > 0.05) of the patient's age, sex, body mass index, primary diagnosis, duration between the 2 radiographs, and the direction of malalignment found on the discrepancy in the measurement of MAD for both limbs. CONCLUSIONS: The standing full-length radiograph with an overlying circular external fixator may not be a reliable indicator of limb alignment and length of the operated extremity. Moreover, the presence of the circular external fixator on the lower extremity can affect the alignment and length of the opposite limb. Clinicians using circular external fixators for lower extremity trauma and reconstruction should be aware of the pitfalls of using a full-length standing radiograph for assessing limb alignment and length during osseous healing. LEVEL OF EVIDENCE: Diagnostic level II.

Slipped capital femoral epiphysis in an obese teenager.

Adolescents are especially prone to develop slipped capital femoral epiphysis (SCFE). Hormonal changes in puberty, obesity, and hypogonadism suggest that endocrine dysfunction is a contributing factor. SCFE may be one of the most common disorders affecting the hip, yet the diagnosis is often missed or delayed as a result of inappropriate initial evaluation, as occurred in this report of a 13-year-old boy. Timely recognition and, typically, surgical intervention are critical to forestall progression and to prevent further complications.