Early Radiographic and Clinical Outcomes Study Evaluating an Integrated Screw and Interbody Spacer for One- and Two-Level ACDF.

BACKGROUND: Multiple techniques and implants can be used in ACDF, the newest of which are integrated cage and screw constructs. These devices may be beneficial over anterior plate constructs due to a negligible anterior profile that may reduce dysphagia. The goal of this study is to review the early radiographical and clinical results associated with a low profile integrated intervertebral cage in one- and two-level anterior column fusions. METHODS: Fusion rates, incidence of hardware failure and deformity correction were assessed through 1 year. Patientreported scores, including VAS for neck pain, and improvements in axial neck pain and neurologic deficit from the preoperative baseline were quantified at 3, 6 and 12 months post-operatively. The incidence of dysphagia was recorded. RESULTS: Lordosis and disc space height at the operated levels increased an average of 4.5° and 3.3mm after device placement (p<0.001). Sagittal plane correction was maintained at 1 year. VAS improved from an average of 5.1 preoperatively to 3.1 immediately postoperatively and was maintained at 12 months. At 3 months, patient-reported improvements in axial neck pain and neurologic deficit were 85% and 93%, respectively. Reported improvements were sustained for both parameters at 12 months (77% and 86%, respectively). Fusion was noted in 93% of the operated levels. There were two documented cases of dysphagia that lasted more than 5 weeks, both following two level ACDFs with the test device (3.5% rate of chronic dysphagia). CONCLUSIONS: The low profile integrated device improved lordosis at the operated level that was maintained at 1 year. Fusion rates with the new device are consistent with ACDF using anterior plating. In combination with improvements in pain and a minimal rate of dysphagia, study findings support the use of integrated interbody spacers for use in one- and two-level ACDF procedures. LEVEL OF EVIDENCE: Level IV, Case Series.

Biomechanical analysis of an interbody cage with three integrated cancellous lag screws in a two-level cervical spine fusion construct: an in vitro study.

BACKGROUND CONTEXT: Despite an increase in the clinical use of no-profile anchored interbody cages (AIC) for anterior cervical discectomy and fusion (ACDF) procedures, there is little published biomechanical data describing its stabilizing effect relative to the traditional anterior plating technique over two contiguous levels. PURPOSE: To biomechanically compare the acute stability conferred by a stand-alone interbody fusion device with three integrated fixation screws ("anchored cage") with a traditional six-hole rigid anterior plate in a two contiguous levels (C4-C5+C5-C6) fusion construct. We hypothesized that the anchored cage would confer comparable segmental rigidity to the cage and anterior plate construct. STUDY DESIGN: A biomechanical laboratory study using cadaveric human cervical spines. METHODS: Seven (n=7) cadaveric human cervical spines (C3-C7) were subjected to quasistatic, pure-moment loading (±1.5 Nm) in flexion-extension (flex/ext), right/left lateral bending (RB/LB), and right/left axial rotation (RR/LR) for the following test conditions: intact; after discectomy and insertion of the AIC at C4-C5 and C5-C6 with anchoring screws engaged; after the removal of the integrated anchoring screws and instrumentation of an anterior locking plate (ALP) over both levels; and cage-only (CO) configuration with screws and anterior plate removed. Intervertebral range of motion (ROM) at the instrumented levels was the primary biomechanical outcome. RESULTS: Flex/ext, RB/LB, and RR/LR ROMs were significantly reduced (p<.001) over both levels by AIC and ALP constructs relative to the CO construct. Significant reduction in flex/ext motion was achieved with the ALP (6.8±3.7) relative to the AIC (10.2°±4.6°) (p=.041) construct. No significant differences were seen in ROM reductions over the two levels between the AIC and APL groups in lateral bending or axial rotation (p>.826). CONCLUSIONS: The anchored cage fusion construct conferred similar acute biomechanical stability in lateral bending and axial rotation ROMs relative to rigid anterior plating. We identified a statistically significant reduction (Δ=3.4°, combined over two levels) in sagittal plane ROM conferred by the ALP relative to the AIC construct. Our biomechanical findings may support the clinical use of no-profile integrated interbody devices over two contiguous levels in ACDF.

Motion preservation surgery in the spine.

The primary goal of motion preservation surgery in the spine is to maintain normal or near normal motion in an attempt to prevent adverse outcomes commonly seen with conventional spinal fusion, most notably the development of adjacent-level degenerative disc disease. Several different surgical approaches have been developed to preserve motion in the lumbar spine, including total disc replacement, partial disc (nucleus) replacement, interspinous spacers, dynamic stabilization devices, and total facet replacement devices. The design of devices varies greatly. The devices are created using a similar rationale but are unique in design relative to their lumbar counterparts.

Indirect decompression of lumbar stenosis with transpsoas interbody cages and percutaneous posterior instrumentation.

BACKGROUND: The minimally invasive lateral transpsoas retroperitoneal approach to address lumbar stenosis offers advantages to traditional approaches, including sparing of the AP annulus and longitudinal ligament and less risk to the peritoneal contents and retroperitoneal vascular structures. Few studies have presented longitudinal measures of radiographic indirect decompression and relief of pain and restoration of function using the lateral approach to spine fusion. QUESTION/PURPOSES: We determined (1) whether radiographic measures suggestive of decompression were achieved after surgery and maintained 1 year after surgery, (2) whether the intervention resulted in sustained improvements in patient-reported outcomes scores 1 year after surgery, and (3) the frequency of pseudarthrosis on CT scans at 1 year after surgery in patients with moderate or severe lumbar stenosis treated with the approach. METHODS: Between 2008 and 2012, 158 patients were surgically treated to alleviate symptoms associated with degenerative lumbar stenosis, of whom 60 (38%) were treated with lateral lumbar interbody fusion. Of these 60 patients, 36 (60%) received CT scans preoperatively and at 1-year postoperatively and were available for radiographic analysis. Of the 60 treated patients, 16 (27%) were lost to followup before 12 months, leaving the records of 44 patients available for review of patient-reported improvements in pain and return to function. Radiographic increases in disc height, foraminal area, and canal area were measured by one observer on CT scans postoperatively and at 1 year and compared to preoperative values. Patient-reported scores, including VAS pain score and Oswestry Disability Index (ODI), were collected preoperatively and at 3 and 12 months postoperatively. RESULTS: Increases in disc height (67%, p < 0.001), foraminal area (24%-31%, p < 0.001), and canal area (7%, p = 0.011) measured immediately postoperatively were sustained at 1-year followup. VAS pain score and ODI both improved (p < 0.001) at 3 months and were maintained at 1 year. No pseudarthroses were noted radiographically. CONCLUSIONS: The lateral transpsoas approach to interbody fusion is capable of sustaining indirect decompression of the neural structures and resolving preoperative claudication and radiculopathy. A larger series of patients with longer followup should be studied to substantiate these early clinical results. LEVEL OF EVIDENCE: Level IV, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.

Postero-lateral disc prosthesis combined with a unilateral facet replacement device maintains quantity and quality of motion at a single lumbar level.

BACKGROUND: Mechanically replacing one or more pain generating articulations in the functional spinal unit (FSU) may be a motion preservation alternative to arthrodesis at the affected level. Baseline biomechanical data elucidating the quantity and quality of motion in such arthroplasty constructs is non-existent. PURPOSE: The purpose of the study was to quantify the motion-preserving effect of a posterior total disc replacement (PDR) combined with a unilateral facet replacement (FR) system at a single lumbar level (L4-L5). We hypothesized that reinforcement of the FSU with unilateral FR to replace the resected, native facet joint following PDR implantation would restore quality and quantity of motion and additionally not change biomechanics at the adjacent levels. STUDY DESIGN: In-vitro study using human cadaveric lumbar spines. METHODS: Six (n = 6) cadaveric lumbar spines (L1-S1) were evaluated using a pure-moment stability testing protocol (±7.5 Nm) in flexion-extension (F/E), lateral bending (LB) and axial rotation (AR). Each specimen was tested in: (1) intact; (2) unilateral FR; and (3) unilateral FR + PDR conditions. Index and adjacent level ROM (using hybrid protocol) were determined opto-electronically. Interpedicular travel (IPT) and instantaneous center of rotation (ICR) at the index level were radiographically determined for each condition. ROM, ICR, and IPT measurements were compared (repeated measures ANOVA) between the three conditions. RESULTS: Compared to the intact spine, no significant changes in F/E, LB or AR ROM were identified as a result of unilateral FR or unilateral FR + PDR. No significant changes in adjacent L3-L4 or L5-S1 ROM were identified in any loading mode. No significant differences in IPT were identified between the three test conditions in F/E, LB or AR at the L4-L5 level. The ICRs qualitatively were similar for the intact and unilateral FR conditions and appeared to follow placement (along the anterior-posterior (AP) direction) of the PDR in the disc space. CONCLUSION: Biomechanically, quantity and quality of motion are maintained with combined unilateral FR + PDR at a single lumbar spinal level.

A cadaveric radiographic analysis on the effect of extreme lateral interbody fusion cage placement with supplementary internal fixation on indirect spine decompression.

STUDY DESIGN: Cadaveric Biomechanical and Radiographic Analysis. OBJECTIVE: The purpose of this study was to quantify the changes in intervertebral height and lateral and central recess areas afforded by lateral interbody fusion cages with 2 supplemental forms of internal fixation in cadaveric specimens. BACKGROUND DATA: When conservative treatment for symptomatic lumbar stenosis fails, traditional intervention has been direct posterior decompression. The minimally invasive, lateral transpsoas approach may be a viable alternative to direct decompression by providing restoration of the foraminal and intervertebral dimensions, yet few reports have examined the anatomic and radiographic changes that occur using this technique. METHODS: Computed tomography (CT) scans were taken of 18 intact lumbar (L1-S1) cadaveric specimens under a 400 N preload. Intervertebral height, foraminal areas, and canal area were measured at L3-L4 and L4-L5. Thereafter, the cadaveric specimens were instrumented with lateral cages placed in the central or posterior third of the disk space at L3-L4 and L4-L5 and either (1) lateral plate (n=9) or (2) bilateral posterior pedicle screw fixation (n=9). All constructs were again subjected to a 400 N preload, postinstrumentation CT scans were taken, and changes in intervertebral height and lateral and central recess areas were calculated. RESULTS: There was no effect of cage placement on any radiographic metric of indirect decompression for either fusion construct. In the lateral plate and pedicle screw groups, respectively, significant increases in average posterior disk height (30.9%, 60.1%), average right (35.3%, 61.5%) and left foraminal area (48.3%, 57.8%), and average canal area (32.3%, 33.3%) were observed. Pedicle screw instrumentation afforded a significantly greater increase in average posterior disk height and foraminal area compared with the lateral plate group, though there was no difference in the average increase in canal area afforded by either form of fixation. CONCLUSIONS: The radiographic results reported here using a cadaveric model add validity to the underlying rationale described for the minimally invasive lateral approach technique. Increases in disk height, foraminal and canal areas were not dependent on cage positioning within the disk space. As intraoperative placement of a cage in the central portion of the disk is an easier and safer technique, our results suggest that central placement may be preferable in a clinical setting.

Biomechanics of an integrated interbody device versus ACDF anterior locking plate in a single-level cervical spine fusion construct.

BACKGROUND CONTEXT: No profile, integrated interbody cages are designed to act as implants for cervical spine fusion, which obviates the need for additional internal fixation, combining the functionality of an interbody device and the stabilizing benefits of an anterior cervical plate. Biomechanical data are needed to determine if integrated interbody constructs afford similar stability to anterior plating in single-level cervical spine fusion constructs. PURPOSE: The purpose of this study was to biomechanically quantify the acute stabilizing effect conferred by a single low-profile device design with three integrated screws ("anchored cage"), and compare the range of motion reductions to those conferred by a standard four-hole rigid anterior plate following instrumentation at the C5-C6 level. We hypothesized that the anchored cage would confer comparable postoperative segmental rigidity to the cage and anterior plate construct. STUDY DESIGN: Biomechanical laboratory study of human cadaveric spines. METHODS: Seven human cadaveric cervical spines (C3-C7) were biomechanically evaluated using a nondestructive, nonconstraining, pure-moment loading protocol with loads applied in flexion, extension, lateral bending (right+left), and axial rotation (left+right) for the intact and instrumented conditions. Range of motion (ROM) at the instrumented level was the primary biomechanical outcome. Spines were loaded quasi-statically up to 1.5 N-m in 0.5 N-m increments and ROM at the C5-C6 index level was recorded. Each specimen was tested in the following conditions: 1. Intact 2. Discectomy+anchored cage (STA) 3. Anchored cage (screws removed)+anterior locking plate (ALP) 4. Anchored cage only, without screws or plates (CO) RESULTS: ROM at the C5-C6 level was not statistically different in any motion plane between the STA and ALP treatment conditions (p>.407). STA demonstrated significant reductions in flexion/extension, lateral bending, and axial rotation ROM when compared with the CO condition (p<.022). CONCLUSIONS: In this in vitro biomechanical study, the anchored cage with three integrated screws afforded biomechanical stability comparable to that of the standard interbody cage+anterior plate cervical spine fusion approach. Due to its low profile design, this anchored cage device may avoid morbidities associated with standard anterior plating, such as dysphagia.

Biomechanics of lateral plate and pedicle screw constructs in lumbar spines instrumented at two levels with laterally placed interbody cages.

BACKGROUND CONTEXT: The lateral transpsoas approach to interbody fusion is gaining popularity because of its minimally invasive nature and resultant indirect neurologic decompression. The acute biomechanical stability of the lateral approach to interbody fusion is dependent on the type of supplemental internal fixation used. The two-hole lateral plate (LP) has been approved for clinical use for added stabilization after cage instrumentation. However, little biomechanical data exist comparing LP fixation with bilateral pedicle screw and rod (PSR) fixation. PURPOSE: To biomechanically compare the acute stabilizing effects of the two-hole LP and bilateral PSR fusion constructs in lumbar spines instrumented with a lateral cage at two contiguous levels. STUDY DESIGN: Biomechanical laboratory study of human cadaveric lumbar spines. METHODS: Eighteen L1-S1 cadaveric lumbar spines were instrumented with lateral cages at L3-L4 and L4-L5 after intact kinematic analysis. Specimens (n=9 each) were allocated for supplemental instrumentation with either LP or PSR. Intact versus instrumented range of motion was evaluated for all specimens by applying pure moments (±7.5 Nm) in flexion/extension, lateral bending (LB) (left+right), and axial rotation (AR) (left+right). Instrumented spines were later subjected to 500 cycles of loading in all three planes, and interbody cage translations were quantified using a nonradiographic technique. RESULTS: Lateral plate fixation significantly reduced ROM (p<.05) at both lumbar levels (flexion/extension: 49.5%; LB: 67.3%; AR: 48.2%) relative to the intact condition. Pedicle screw and rod fixation afforded the greatest ROM reductions (p<.05) relative to the intact condition (flexion/extension: 85.6%; LB: 91.4%; AR: 61.1%). On average, the largest interbody cage translations were measured in both fixation groups in the anterior-posterior direction during cyclic AR. CONCLUSIONS: Based on these biomechanical findings, PSR fixation maximizes stability after lateral interbody cage placement. The nonradiographic technique served to quantify migration of implanted hardware and may be implemented as an effective laboratory tool for surgeons and engineers to better understand mechanical behavior of spinal implants.

Effects on inadvertent endplate fracture following lateral cage placement on range of motion and indirect spine decompression in lumbar spine fusion constructs: A cadaveric study.

BACKGROUND: The lateral transpsoas approach to interbody fusion is gaining popularity. Existing literature suggests that perioperative vertebra-related complications include endplate breach owing to aggressive enedplate preparation and poor bone quality. The acute effects of cage subsidence on stabilization and indirect decompression at the affected level are unknown. The purpose of this study was to compare the kinematics and radiographic metrics of indirect decompression in lumbar spines instrumented with laterally placed cages in the presence of inadvertent endplate fracture, which was determined radiographically, to specimens instrumented with lateral cages with intact endplates. METHODS: Five levels in 5 specimens sustained endplate fracture during lateral cage implantation followed by supplementary fixation (pedicle screw/rod [PSR]: n = 1; anterolateral plate [ALP]: n = 4), as part of a larger laboratory-based study. Range of motion (ROM) in these specimens was compared with 13 instrumented specimens with intact endplates. All specimens were scanned using computed tomography (CT) in the intact, noninstrumented condition and after 2-level cage placement with internal fixation under a 400-N follower load. Changes in disc height, foraminal area, and canal area were measured and compared between specimens with intact endplates and fractured endplates. RESULTS: Subsidence in the single PSR specimen and 4 ALP specimens was 6.5 mm and 4.3 ± 2.7 mm (range: 2.2-8.3 mm), respectively. ROM was increased in the PSR and ALP specimens with endplate fracture when compared with instrumented specimens with intact endplates. In 3 ALP specimens with endplate fracture, ROM in some motion planes increased relative to the intact, noninstrumented spine. These increases in ROM were paralleled by increase in cage translations during cyclic loading (up to 3.3 mm) and an unpredictable radiographic outcome with increases or decreases in posterior disc height, foraminal area, and canal area when compared with instrumented specimens with intact endplates. CONCLUSIONS: Endplate fracture and cage subsidence noted radiographically intraoperatively or in the early postoperative period may be indicative of biomechanical instability at the affected level concomitant with a lack of neurologic decompression, which may require revision surgery.

Corpectomy with titanium cage reconstruction in the cervical spine.

Multi-level anterior cervical discectomy and fusion (ACDF) has been utilized by many surgeons to address multi-level cervical disease with the use of autograft or allograft. High failure rates have been reported in three-level decompressions when autograft is used, which increases with the use of allograft. This has led many surgeons to advocate anterior cervical corpectomy with strut grafting where only two surfaces are needed for fusion compared to the multiple surfaces required for multi-level ACDF. We retrospectively evaluated the efficacy of titanium cage use with autologous bone graft (resected vertebral bodies) and anterior cervical plating in 38 consecutive patients (aged 18-73 years) undergoing cervical decompression and corpectomy. Medical records were examined along with an outcome interview conducted in-person or by phone. Postoperative immobilization was achieved with a rigid cervical collar. Fusion was assessed by antero-posterior (AP), lateral, and flexion-extension radiographs and cervical spine CT scans. Fusion was assessed by AP, lateral, and flexion-extension radiographs and cervical spine CT scans. Clinical results included an exit interview. Solid bony fusion with graft incorporation was found in 37 of 38 patients (97.5%) at six months and 100% in one year. Compared to preoperative levels, 84% of patients rated their overall quality of life to have improved by 50% or greater and would have the same surgery again given the same conditions. There were few complications. Thus, titanium cage reconstruction with the use of autologous bone from a corpectomy and the use of an anterior cervical plate is an effective means of reconstruction after decompressive cervical corpectomy, and we conclude this is a viable alternative to multi-level ACDF or to procedures involving long strut grafts obtained from the patient or bone bank.

New techniques in lumbar spinal instrumentation: what the radiologist needs to know.

Lumbar spinal fusion is a commonly performed procedure, and, despite changes in cage types and fixation hardware, radiologists have, over the years, become familiar with the imaging features of typical spinal fusion and many of the complications seen in patients after surgery, including pseudoarthrosis, hardware loosening, and recurrent or residual disk herniation. Recently, however, novel approaches and devices have been developed, including advances in minimally invasive surgery, the increasing use of osteoinductive materials, and a wide variety of motion-preserving devices. These new approaches and devices manifest with characteristic imaging features and the potential for unusual and unexpected complications. Several of these devices and approaches are experimental, but many, including those devices used in lateral approaches to fusion, as well as the use of bone morphogenic protein, disk arthroplasty, and interspinous spacers, are seen with increasing frequency in daily clinical practice. Given the recent advances in spinal fusion surgery, it is important that radiologists have a basic understanding of the rationale behind these procedures, the common imaging features of the devices, and the complications associated with their use.

Early surgeon impressions and technical difficulty associated with laparoendoscopic single-site surgery: a Society of American Gastrointestinal and Endoscopic Surgeons Learning Center study.

BACKGROUND: Interest in laparoendoscopic single-site surgery (LESS) is growing rapidly among surgeons. This study aimed to characterize current surgeon impressions about LESS and to determine the relative difficulty of performing a simulated LESS task using a multiport access device. METHODS: This study was conducted at the 2009 Society of Gastrointestinal Endoscopic Surgeons (SAGES) Learning Center. The 56 study participants were asked to complete pre- and post-test questionnaires regarding their level of training, prior clinical experience, and opinions about LESS. Technical skill performance was evaluated using the standardized fundamentals of laparoscopic surgery Peg Transfer task scored according to time and error metrics. The participants completed three repetitions: conventional laparoscopy (LAP), LESS with nonarticulated instruments (LESS Straight), and LESS with articulated instruments (LESS Articulating). RESULTS: Complete data were collected for 45 (80%) of the 56 participants, which included 27 practicing surgeons, nine minimally invasive surgery (MIS) fellows, seven residents, and two allied health professionals. Five surgeons (LESS experienced) had managed at least one LESS case in the preceding 6 months. Participants rated their comfort with LESS as 2.0 ± 1.2 (5-point scale, 1 = very uncomfortable). Compared with conventional laparoscopy, the participants indicated that LESS had 97% better cosmesis, 25% decreased postoperative pain, 18% faster recovery, 97% more demanding, 73% increased rate of complications, and 82% anticipated wide adoption. They all indicated a readiness to offer LESS to their patients if appropriately trained. Peg Transfer performance was significantly worse for LESS than for LAP (40-65% performance decline), and for LESS Articulating than for LESS Straight (44% performance decline). Construct validity for the LESS simulated tasks was supported because the LESS-experienced scores were significantly better than the LESS-nonexpert scores. CONCLUSION: Despite the increased technical difficulty associated with the LESS approach, surgeons are enthusiastic about offering these techniques and seeking additional training. Robust simulation-based methods that foster skill acquisition through repetitive practice and verification of proficiency are needed such that safe adoption may be fostered.

Hybrid dynamic stabilization with posterior spinal fusion in the lumbar spine.

BACKGROUND: Instrumented lumbar arthrodesis has been established as the gold standard in the care of patients with degenerative disc disease. However, spinal fusion results in the elimination of motion of the functional spinal unit and has been implicated in the development of adjacent-level degeneration. Motion-preserving devices such as the dynamic rod allow for stabilization of a pathologic motion segment above a fused segment and create a transitional zone (index level) that decreases the loads applied to the supra-adjacent normal segment. METHODS: After institutional review board approval, 28 patients were included in this prospective, consecutive, nonrandomized clinical trial. Each subject was consented for dynamic stabilization. There was no attempt at fusion at the dynamic level. The cohort underwent a posterior lateral spinal fusion with single- or 2-level transforaminal lumbar interbody fusion by use of a cage, with superior-level posterior dynamic instrumentation. Functional clinical outcomes were measured with a 100-point visual analog scale, Oswestry Disability Index, and Short Form 36 questionnaire. Radiographic measurements, fusion evaluation, complications, and screw loosening were recorded. RESULTS: A minimum of 24 months' follow-up data included 22 patients. No device failure or screw breakage was identified. Postoperative range of motion averaged 2.5° at the index level, and the superior adjacent-level range of motion remained unchanged (P > .05). Disc height was preserved at all levels (P > .05). Of 180 screws, 6 (3%) showed radiographic loosening. Functional outcomes showed significant improvement in mean postoperative visual analog scale score by 24.7 points (P < .01) and Oswestry Disability Index by 27.6 points (P < .01), as well as the Short Form 36 physical (P < .01) and mental (P < .05) components from baseline to 2-year follow-up. CONCLUSIONS: Our preliminary results at 2 years are satisfactory. CLINICAL RELEVANCE: Ultimately, further follow-up will assess the potential for this treatment to delay adjacent-level changes in the long term.

Effects of preoperative education on spinal surgery patients.

BACKGROUND: Preoperative patient education (PE) has been used by many institutions to deal with patient anxiety, pain control, and overall satisfaction. Although the literature suggests PE's effectiveness in joint reconstruction, data are missing in spinal surgery. METHODS: We retrospectively analyzed patients having elective spinal surgery who underwent PE (spine pre-care class) from October 2009 to March 2010. Of the 155 patients surveyed, 77 (49.7%) attended the class whereas 78 (50.3%) did not. RESULTS: Of the participants in the pre-care class, 96% were satisfied with their pain management versus 83% in the control group (P =.02). There was also a trend for better overall satisfaction in the pre-care class group (91% vs 85%; P > .05, multiple regression analysis). Elderly women tend to be less satisfied with pain management and overall treatment. CONCLUSIONS: Implementation of PE has had a positive impact on patient satisfaction, especially in terms of pain management.

Two-year skill retention and certification exam performance after fundamentals of laparoscopic skills training and proficiency maintenance.

BACKGROUND: The purpose of this study was to determine 2-year performance retention and certification exam pass rate after completion of a proficiency-based fundamental laparoscopic skills (FLS) curriculum and subsequent interval training. METHODS: Surgery residents (postgraduate year [PGY]1-5, n = 91) were enrolled in an Institutional Review Board approved protocol. All participants initially underwent proficiency-based training on all 5 FLS tasks. Subsequently, available residents were enrolled every 6 months in an ongoing training curriculum that included retention tests on tasks 4 and 5, with mandatory retraining to proficiency if the proficiency levels were not achieved. The final retention test included the actual FLS certification examination for PGY4-5 trainees. RESULTS: A 96% participation rate was achieved for all curricular components during the 2-year study period (PGY3-5, n = 33). Skill retention at retention 1-4 was 83%, 94%, 98%, and 91% for task 4 and 85%, 95%, 96%, and 100% for task 5, respectively. All PGY4-5 (n = 20) residents passed the FLS certification examination, achieving 413 +/- 28 total score on the skills portion (passing score > or =270) and demonstrating 92% retention for all 5 tasks. CONCLUSION: Proficiency-based training with subsequent ongoing practice results in a very high level of skill retention after 2 years and uniformly allows trainees to pass the FLS certification examination.

Video. Modified single-incision laparoscopic adjustable gastric band.

INTRODUCTION: This video describes a modified single-incision laparoscopic approach for adjustable gastric band placement. METHOD: The patient was a 28-year-old female with a BMI of 48.75 with no prior surgery but with numerous comorbidities. With the patient placed in a split-leg position and in steep reverse Trendelenburg, a 12-mm optical trocar is placed 12 cm distal to the xiphoid process in the left paramedian location. A Nathanson liver retractor is placed through a midepigastric 5-mm incision. Two 5-mm low-profile trocars are placed next to the 12-mm trocar through separate incisions (this maintains stability of each cannula) and a 5-mm 45 ° laparoscope is used. Using an automated suturing device, a stay suture is placed high on the fundus and externalized for retraction. An articulating band passer dissects the phrenogastric attachments at the angle of His. The 12-mm port is removed and the gastric band is inserted. The GE junction fat pad is excised and the Pars Flaccida membrane is divided using conventional instruments. A second traction suture is placed to retract the lesser curve fat and right crus fat pad. A peritoneal bite is also taken in the left lateral subcostal area such that when this suture is externalized, it acts as a pulley. An articulating 5-mm grasper is used to develop the retrogastric tunnel. Then the band is fed into position and its buckle is locked. Three interrupted sutures are placed to create an anterior gastric plication and a fourth antislippage suture is placed below the band along the lesser curve. The band tubing is externalized and the port is implanted by joining the three working trocar incisions into a single 4.5-cm incision. RESULTS: The patient did well postoperatively with no complications. CONCLUSIONS: A modified single incision approach for laparoscopic gastric band placement is feasible and provides patients with improved cosmesis.

Proficiency-based Fundamentals of Laparoscopic Surgery skills training results in durable performance improvement and a uniform certification pass rate.

BACKGROUND: The authors have previously documented a 100% certification pass rate immediately after a proficiency-based skills training curriculum for the Fundamentals of Laparoscopic Surgery (FLS) program. This study aimed to determine the durability of skills acquired after initial training. METHODS: For this study, 21 novice medical students were enrolled in institutional review board (IRB)-approved protocols at two institutions. As previously reported, all the participants successfully completed a structured proficiency-based training curriculum by practicing the five FLS tasks in a distributed fashion over a 2-month period. Pre- and posttesting was conducted, and standard testing metrics were used. The participants were recruited for repeat testing 6 months (retention 1) and 1 year (retention 2) after initial curriculum completion. Of the original 21 students, 15 (10 at University of Texas Southwestern and 5 at Uniformed Services University) were available and agreed to participate. The participants had no additional skills lab training and minimal clinical laparoscopic exposure. RESULTS: None of the 15 participants demonstrated proficiency at the initial pretest (mean score, 146 ± 65), and performance showed significant improvement (p < 0.001) at the posttest (469 ± 20). The participants retained a very high level of performance at retention 1 (437 ± 39; 93% retention of the posttest score) and retention 2 (444 ± 55; 95% retention of the posttest score). Their performance at both retention testing-intervals was sufficient for passing the certification exam (270 cutoff score for passing) with a comfortable margin. There were no significant differences in performance between the two institutions at any time points. CONCLUSION: The proficiency-based FLS skills curriculum reliably results in a high level of skill retention, even in the absence of ongoing simulator-based training or clinical experience. This curriculum is suitable for widespread implementation.

Preparing medical students to enter surgery residencies.

BACKGROUND: This study was designed to develop and evaluate an integrated cognitive and proficiency-based skills curriculum based on American College of Surgeons Graduate Medical Education Committee (ACGME) competencies to prepare students for surgery internships. METHODS: Course content included cadaver dissections, didactic sessions, team training, and training in clinical and technical skills. Using previously validated skills curricula (12 open and 5 Fundamental Laparoscopic Surgery [FLS] tasks), trainees underwent pretest, self-practice to proficiency, and post-test. Surveys regarding confidence levels and skills were administered. RESULTS: Mean course evaluation score was 4.5 +/- .6 on a 5-point Likert scale. Trainees (n = 9) achieved proficiency on open tasks and FLS tasks 2-5. The mean confidence self-rating on 51 skills increased on a 5-point Likert scale from 2.4 +/- .6 to 4.0 +/- .6 (P < .001). CONCLUSIONS: This integrated curriculum did improve confidence levels, and skills proficiency can be achieved in an abbreviated time. The anticipated result would be enhanced baseline abilities for internship.

Pretraining on Southwestern stations decreases training time and cost for proficiency-based fundamentals of laparoscopic surgery training.

BACKGROUND: We previously reported a proficiency-based Fundamentals of Laparoscopic Surgery (FLS) curriculum that uniformly resulted in passing the technical skills certification criteria. We hypothesized that pretraining using the Southwestern (SW) videotrainer stations would decrease costs and training time and maintain benefits. STUDY DESIGN: Group I (2nd-year medical student, n = 10) underwent FLS pretesting (Pretest 1), SW station proficiency-based training, repeat FLS testing (Pretest 2), FLS proficiency-based training, and final FLS testing (Posttest). These data were compared with a historic control, group II (2nd-year medical student, n = 10), which underwent FLS pretesting (Pretest 1), proficiency-based training, and final FLS testing (Posttest). RESULTS: During training, group I achieved proficiency (85.4 + or - 26.2 repetitions) for all SW tasks. For both groups, proficiency was achieved for 96% of the FLS tasks, with substantial differences detected for group I and group II repetitions (100.5 + or - 15.9 versus 114 + or - 25.5) and training time (6.0 + or - 1.5 versus 9.2 + or - 2.2 hours), respectively. Per-person material costs were considerably different for groups I and II ($827 + or - 116 versus $1,108 + or - 393). Group I demonstrated significant improvement from Pretest 1 (149 + or - 39; 0% FLS pass rate) to Pretest 2 (293 + or - 83; p < 0.001; 60% FLS pass rate), and to Posttest (444 + or - 60; p < 0.001; 100% FLS pass rate). Group II demonstrated significant improvement from Pretest 1 (158 + or - 78; 0% FLS pass rate) to Posttest (469.7 + or - 12.0; p < 0.001; 100% FLS pass rate). CONCLUSIONS: Pretraining on SW stations decreases training time for FLS skill acquisition and maintains educational benefits. This strategy decreases costs associated with using consumable materials for training.

Maintaining proficiency after fundamentals of laparoscopic surgery training: a 1-year analysis of skill retention for surgery residents.

BACKGROUND: The purpose of this study was to determine performance retention after initial and ongoing Fundamentals of Laparoscopic Surgery (FLS) skills training. METHODS: Surgery residents (postgraduate year [PGY] 1-5; n = 91) initially underwent proficiency-based training during a 2-month period for all 5 FLS tasks. Subsequently, available residents (PGY 2-5; n = 44) were enrolled in a follow-up curriculum for Tasks 4 and 5, with retention testing at 6.5 +/- 1.0 months (Retention 1) and 12.5 +/- 1.3 months (Retention 2), followed by mandatory retraining if needed. RESULTS: Forty-two residents participated in the follow-up curriculum. For Task 4, retraining was required for 55% of trainees after Retention 1 and for 40% after Retention 2 testing. For Task 5, retraining was required for 86% of trainees after Retention 1 and for 48% after Retention 2 testing. Compared with posttest performance, skill retention was 86% and 96% for Task 4 and 87% and 96% for Task 5 at Retentions 1 and 2, respectively. CONCLUSION: A modest decrement in performance was detected at 6.5 months, but a small amount of additional structured practice reinforced skill acquisition and minimized skill loss at 12.5 months. In addition to clinical experience, trainees may benefit from ongoing FLS simulator training to optimally maintain proficiency.