Estimation of conditional power in the presence of auxiliary data.

Conditional power (CP) is a commonly used tool to inform interim decision-making in clinical trials, but the conventional approach using only primary endpoint data to calculate CP may not perform well when the primary endpoint requires a long follow-up period, or the treatment effect size changes during the trial. Several methods have been proposed to use additional short term auxiliary data observed at the interim analysis to improve the CP estimation in these situations, however, they may rely on strong assumptions, have limited applications, or use ad hoc choices of information fraction. In this paper we propose a general framework where the true CP formula is first derived in the presence of auxiliary data, and CP estimation is obtained by substituting the unknown parameters with consistent estimators. We conducted extensive simulations to examine the performance of both proposed and conventional approaches using the true CP as the benchmark. As the proposed approach is based on the true underlying CP, the simulations confirmed its superiority over the conventional approach in terms of efficiency and accuracy, especially if observed auxiliary data reflect the change of treatment effect size. The simulations also indicate that the magnitude of improvement in CP estimation is associated with the correlation between auxiliary and primary endpoints and/or the magnitude of the effect size change during the trial.

Post robotic investment: Cost consequences and impact on length of stay for obese women with endometrial cancer.

INTRODUCTION: The aim of the study was to investigate whether robotic-assisted surgery is associated with lower incremental resource use among obese patients relative to non-obese patients after a Danish nationwide adoption of robotic-assisted surgery in women with early-stage endometrial cancer. This is a population-based cohort study based on registers and clinical data. MATERIAL AND METHODS: All women who underwent surgery (robotic, laparoscopic and laparotomy) from 2008 to 2015 were included and divided according to body mass index (<30 and ≥30). Robotic-assisted surgery was gradually introduced in Denmark (2008-2013). We compared resource use post-surgery in obese vs non-obese women who underwent surgery before and after a nationwide adoption of robotic-assisted surgery. The key exposure variable was exposure to robotic-assisted surgery. Clinical and sociodemographic data were linked with national register data to determine costs and bed days 12 months before and after surgery applying difference-in-difference analyses. RESULTS: In total, 3934 women were included. The adoption of robotic-assisted surgery did not demonstrate statistically significant implications for total costs among obese women (€3,417; 95% confidence interval [CI] -€854 to €7,688, p = 0.117). Further, for obese women, a statistically significant reduction in bed days related to the index hospitalization was demonstrated (-1.9 bed days; 95% CI -3.6 to -0.2, p = 0.025). However, for non-obese women, the adoption of robotic-assisted surgery was associated with statistically significant total costs increments of €9,333 (95% CI €3,729-€1,4936, p = 0.001) and no reduction in bed days related to the index hospitalization was observed (+0.9 bed days; 95% CI -0.6 to 2.3, p = 0.242). CONCLUSIONS: The national investment in robotic-assisted surgery for endometrial cancer seems to have more modest cost implications post-surgery for obese women. This may be partly driven by a significant reduction in bed days related to the index hospitalization among obese women, as well as reductions in subsequent hospitalizations.

Long term resource consequences of a nationwide introduction of robotic surgery for women with early stage endometrial cancer.

OBJECTIVE: The majority of cost-studies related to robotic surgery has a short follow-up and primarily report the costs from the index surgery. The aim of this study was to evaluate the long-term resource consequences of introducing robotic surgery for early stage endometrial cancer in Denmark. METHODS: The study included all women with early stage endometrial cancer who underwent robotic, laparoscopic and open access surgery from January 2008 to June 2015. Data was linked from national databases to determine resource consumption and costs from hospital treatments, outpatient contacts, primary health care sector visits, labor market affiliation and prescription of medication. Each patient was observed in a period of 12 months before- and after surgery. The key exposure variable was women who were exposed to robotic surgery compared to those who were not. RESULTS: A total of 4133 women underwent surgery for early stage endometrial cancer. The study found additional costs of $7309 (95% confidence interval [CI] 2100-11,620, P = 0.001) per patient in the group exposed to robotic surgery including long-term costs post-surgery compared to the non-exposed group (non-robotic group). When controlling for time trends, the introduction of robotic surgery did not reduce the number of bed days (mean diff -0.42, 95% CI -3.03-2.19, P = 0.752). CONCLUSIONS: The introduction of robotic surgery for early stage endometrial cancer did not generate any long-term cost savings. The additional costs of robotic surgery were primarily driven by the index surgery. Any reduction in bed days could be explained by time trends.

Medial patellofemoral ligament reconstruction with or without tibial tubercle transfer is an effective treatment for patellofemoral instability.

PURPOSE: The hypotheses were that medial patellofemoral ligament reconstruction (MPFLr) would improve the long-term symptoms of patellofemoral Instability (PFI) and control patellar tilt, based on computed tomography (CT), and that the addition of a TT transfer, when it is necessary, would not deteriorate the outcome. The purpose of this study was to evaluate the long-term clinical and radiographic outcomes of a large series of MPFLr, either isolated or associated with a TT transfer. METHODS: From 133 MPFLr with a minimum of 4 years postoperatively, three groups were defined: isolated MPFLr, MPFLr with tibial tubercle (TT) medialisation or MPFLr with TT medialisation and distalisation. IKDC and Kujala scores were evaluated. Patellar tilt was evaluated on the patient's preoperative and the last available radiograph, and on CT scan measurements performed preoperatively and at 6-month postoperatively. RESULTS: The mean follow-up was 6.3 ± 1.7 years [4.1-10.3] and four patients reported recurrent patellar dislocation. Between pre and postoperative at last follow-up a significant improvement in IKDC and Kujala functional scores was observed (P < 0.01), with no difference between the three groups. Regarding patellar tilt, there were significant decreases in Laurin and Merchant angles and an improvement of the Maldague stage (P < 0.01). The CT analysis of patellar tilt also demonstrates a significant improvement of the patella tilt (P < 0.01). The control of the patella tilt was correlated with a good functional result (P < 0.01). CONCLUSION: The MPFLr, whether isolated or associated with a TT transfer, provides good long-term clinical and radiological outcomes with a low rate of recurrence. The addition of a TT transfer, when necessary, results in the same good outcomes. This article provides a guide for surgeons evaluating PFI to choose the most appropriate procedure. LEVEL OF EVIDENCE: IV.

Clinical and structural outcome twenty years after repair of isolated supraspinatus tendon tears.

BACKGROUND: This study evaluated the clinical and structural outcome 20 years after repair of isolated supraspinatus tendon tears. We hypothesized that the results would deteriorate over time. MATERIALS AND METHODS: For this retrospective multicenter study, 137 patients were recalled for a clinical and imaging assessment. Six patients (4.3%) had died from unrelated causes, 52 (38.0%) were lost to follow-up, and 13 (9.5%) had undergone reoperations. This left 66 patients for clinical evaluation. Radiographs and magnetic resonance imaging were additionally performed for 45 patients, allowing assessment of osteoarthritis, tendon healing, fatty infiltration (FI), and muscle atrophy. RESULTS: The Constant Score (CS) improved from 51.5 ± 14.1 points preoperatively to 71 points (P < .05) with a mean Subjective Shoulder Value (SSV) of 77.2% ± 22%. Tendon discontinuity (Sugaya IV-V) was present in 19 of 45 patients (42 %), and there was advanced FI (Goutallier III-IV) of the supraspinatus in 12 (27%) and of the infraspinatus muscle in 16 (35%). Supraspinatus atrophy was present in 12 patients (28%), advanced arthritis in 6, and cuff tear arthropathy in 12 (30%). The CS and SSV were significantly inferior for shoulders with FI of stages III to IV (P < .05). The CS was lower in cuff tear arthropathy and correlated with infraspinatus FI. CONCLUSIONS: At 20 years after surgical repair of isolated supraspinatus tears, the clinical outcome remains significantly above the preoperative state. FI of the infraspinatus is the most influential factor on long-term clinical outcome.

Estimation and identification issues in the promotion time cure model when the same covariates influence long- and short-term survival.

The promotion time cure model is a survival model acknowledging that an unidentified proportion of subjects will never experience the event of interest whatever the duration of the follow-up. We focus our interest on the challenges raised by the strong posterior correlation between some of the regression parameters when the same covariates influence long- and short-term survival. Then, the regression parameters of shared covariates are strongly correlated with, in addition, identification issues when the maximum follow-up duration is insufficiently long to identify the cured fraction. We investigate how, despite this, plausible values for these parameters can be obtained in a computationally efficient way. The theoretical properties of our strategy will be investigated by simulation and illustrated on clinical data. Practical recommendations will also be made for the analysis of survival data known to include an unidentified cured fraction.

Cementless Total Hip Arthroplasty in Crowe III and IV Dysplasia: High Hip Center and Modular Necks.

BACKGROUND: Total hip arthroplasty (THA) in severe developmental dysplasia of the hip (DDH) is a challenging procedure. The most used techniques involve anatomic cup positioning, augmentation femoral osteotomy. However, anatomic cup positioning is not always feasible in severe DDH and osteotomy nonunion may ensue. The purpose of the study was to assess the survivorship, the hip score results, the radiological parameters (fixation, loosening, component position) of a large cohort of patients with Crowe III and IV DDH, treated with high hip center and modular necks THAs. METHODS: Eighty-four THAs in Crowe III and IV DDH were evaluated, achieving a final follow-up of 15.1 years. All the patients were treated with the same cementless implant (modular necks and ceramic-on-ceramic coupling) and the same approach (high cup placement with slight medialization). The patients were clinically evaluated (Harris Hip score and Merle d'Aubigne and Postel score). A radiographic evaluation was performed, analyzing the orientation of the cup. RESULTS: Eighty patients were available at the last follow-up. The clinical scores were good at the final follow-up. Two sciatic lesions occurred: one patient fully recovered. The overall survivorship was 90.5% at 15 years: only 2 cases of aseptic loosening were reported. The mean center of rotation height was 33 ± 8 mm and the medialization was 30 ± 5 mm. CONCLUSION: A high cup placement with slight medialization is a valid technique in DDH patients. A good restoration of the offset, ceramic-on-ceramic coupling and a porous socket may provide durable results, overcoming the effects of increasing joint reaction forces related to high cup placement.

Case of Barrett's adenocarcinoma with marked endoscopic morphological changes in Barrett's esophagus over a long follow-up period of 15 years.

The natural history of Barrett's esophagus (BE) is unclear. We herein describe a case of Barrett's adenocarcinoma (BAC) in which we could closely observe marked morphological changes in BE over a long follow-up period of 15 years. A man in his seventies received routine esophagogastroduodenoscopy (EGD) and was diagnosed as having reflux esophagitis and short-segment BE. The BE gradually became elongated, and BAC was detected 9 years following the initial EGD examination with continued administration of a proton pump inhibitor. We witnessed that BE elongated sporadically over time and mucosal breaks of reflux esophagitis were detectable several years before elongation. The patient underwent endoscopic submucosal dissection for BAC and has been monitored by EGD every year thereafter. These remarkable morphological changes may be representative of the natural history of BE and aid in deciding long-term disease management.

Post-traumatic in situ fusion after calcaneal fractures: a retrospective study with 7-28 years follow-up.

BACKGROUND: In situ fusion as salvage operation after calcaneal fractures has been used. In this retrospective investigation, a group of in situ fused patients is analyzed with long-term follow-up. METHODS: Twenty-nine patients with in situ single or multiple fusions performed between 1970 and 1990 were included. In 1998 these patients were examined with plain radiographs and computerized tomography (CT) scan of the affected foot. Also, a visual analogue score (VAS) for calcaneal fractures, short form health survey (SF-36), Olerud Molander score and American Orthopaedic Foot and Ankle society (AOFAS) hindfoot score were evaluated. RESULTS: The plain radiographs and CT scan showed severe remaining deformities in these patients. The outcome parameters were generally poor and correlated to the degree of remaining deformity. CONCLUSIONS: Simple in situ fusion, without consideration of the deformity at hand, after a calcaneal fracture is not an adequate treatment and generally associated with poor outcome.

Sea Urchin Spine Embedded in the Sole of the Foot: Eight-Year Radiographic Follow-Up Without Removal.

When sea urchin puncture injuries occur during coastal recreation or work activities, they often affect extremities, such as hands and feet. There is a plethora of information on treatments for these puncture injuries, with the most common among medical professionals being the removal of all partially embedded spines and the removal of as many fully embedded spines as possible. When the spines are deeply embedded and/or fragmented, they might not be removed, especially when they are not located in critical areas such as tendons or joints. This reflects the generally held notion that smaller spines and spine fragments will eventually dissolve or be absorbed. Here we report an unusual case where the tip of a sea urchin spine became embedded in the soft tissue of the sole of the foot of a 21-year-old male after he stepped on one after falling off a kayak off the coast of Oahu, Hawai'i. The deeply embedded spine was not removed. By three weeks after the injury, the patient did not have any symptoms, and eight years later, he was still symptom-free. Radiographs taken one year after the injury showed that the spine had fragmented into two pieces. The smaller piece was about 15% of the size of the original embedded spine, and it had apparently been absorbed (it was not seen on final radiographs eight years later). Analysis of radiographs eight years after the injury showed that the main or large spine fragment was still distinctly detectable in the soft tissue; there was no visible evidence that it had undergone significant absorption or migrated from the original location. The absence of any obvious radiographic rarefaction over eight years is contrary to the lore that sea urchin spines that remain in human soft tissue will exhibit significant, or complete, absorption or dissolution over months to a few years.

Five-year clinical follow-up of arthroscopically treated chronic ankle instability.

INTRODUCTION: Arthroscopic treatment of lateral ankle instability is a recent innovation. In 2014, a prospective study was initiated by the French Society of Arthroscopy demonstrating the feasibility, morbidity and short-term results of arthroscopic treatment of ankle instability. HYPOTHESIS: The functional results of arthroscopic treatment of chronic ankle instability found after one year were maintained in the medium term. MATERIAL AND METHODS: The prospective follow-up of the patients included in the initial cohort was continued. The Karlsson and AOFAS scores, as well as patient satisfaction, were assessed. The causes of failure underwent univariate and multivariate analyzes. The results of 172 patients were included (40.2% ligament repairs; 59.7% ligament reconstructions). The average follow-up was 5years. The average satisfaction was 8.6/10, the average Karlsson score was 85 points and the average AOFAS score was 87.5 points. The reoperation rate was 6.4% of patients. The failures were related to an absence of sports practice, a high BMI and female gender. A high BMI and the intense sports practice were associated to ligament repair failure. The absence of sports practice and the intraoperative presence of the anterior talofibular ligament were associated to ligament reconstruction failure. DISCUSSION: Arthroscopic treatment of ankle instability confers high satisfaction in the medium term, as well as long-lasting results with a low reoperation rate. A more detailed evaluation of the failure criteria could help guide the choice of treatment between ligament reconstruction or repair. LEVEL OF EVIDENCE: II.

The Very Long COVID: Persistence of Symptoms after 12-18 Months from the Onset of Infection and Hospitalization.

According to the World Health Organization's definition, long COVID is the persistence or development of new symptoms 3 months after the initial infection. Various conditions have been explored in studies with up to one-year follow-up but very few looked further. This prospective cohort study addresses the presence of a wide spectrum of symptoms in 121 patients hospitalized during the acute phase of COVID-19 infection, and the association between factors related to the acute phase of the disease and the presence of residual symptoms after one year or longer from hospitalization. The main results are as follows: (i) post-COVID symptoms persist in up to 60% of the patient population at a mean follow-up of 17 months; (ii) the most frequent symptoms are fatigue and dyspnea, but neuropsychological disturbances persist in about 30% of the patients (iii) when corrected for the duration of follow-up with a freedom-from-event analysis; only complete (2 doses) vaccination at the time of hospital admission remained independently associated with persistence of the major physical symptoms, while vaccination and previous neuropsychological symptoms remained independently associated with persistence of major neuropsychological symptoms.

Specific Design of a Press Fit Humeral Stem Provides low Stress Shielding in Reverse Shoulder Arthroplasty at minimum 5 Years FU.

Press fit fixation is becoming more popular in RSA to preserve, in theory, bone capital. Several studies report that bone resorption can be very high around humeral stems depending on their size, shape and mode of fixation. The aim of the current study is to mid-term follow-up clinical and radiological result of a press fit ovoid regular stem RSA in non acute trauma cases. Materials and Methods: We performed a retrospective monocentric study of patients continuously implanted with the Humeris® stem RSA for degenerative change of the shoulder. Nineteen shoulders, in eighteen patients (74.6 y.o (from 69 to 81)), were available at minimum five years follow-up. Results: The mean final adjusted Constant score was 111.9 (65 to 130), and the mean ASES score was 49.82 (10 to 60). Humeral resorption was observed in 21% of cases. We found a statistically significant (p = .014) lower adjusted Constant score in patients presenting with resorption on post-operative X-rays compared to those without resorption (115.6 vs. 98.25). Half cases of patients presenting a resorption underwent L'Episcopo procedure during surgery. Humeral resorption occurs the first year after surgery and do not increase even 8 years after surgery. Analysis demonstrated no correlation between the value of filling ratios and bone resorption. Conclusion: The current study confirms a low rate of stress shielding around the studied stem, with rare bony resorption and no osteopenia around the humeral stem. This study highlights the importance of choosing the appropriate proximal shape and length of the humeral stem for press fit fixation in RSA.

Bone wax in the treatment of partial epiphysiodesis of distal femoral growth plate: Case report at 10-year follow-up.

The growth plate is the weakest structure in the skeleton of a child and a frequent site of injury or fracture; physeal injuries represent 15%-30% of all fractures in children. Of all growth plate fractures, the incidence of growth arrest and disorders is around 15%. Here, we discuss a female patient who, at the age of 5 years, was treated for a polytrauma that involved a complex lesion of the growth plates of the knee. Four days after trauma, she underwent closed reduction surgery and internal fixation with cannulated screws for femoral and tibial fractures of the growth plate. A 20° valgus deviation of the left knee was found at 3-month postoperative clinical check-up likely as a result of a growth disorder of the femur. She was diagnosed with valgus knee secondary to epiphysiodesis of the lateral portion of the femoral physis and she was readmitted to the hospital. In the operating theater, an open femoral de-epiphysiodesis was performed with a burr; the drilled hole was then filled with bone wax. At 20-month post-trauma follow-up, the left knee was still valgus about 20° relative to the other side. During follow-up, a slow but progressive improvement in the axis of the lower limbs was noted. Clinical and radiographic control 10 years after the trauma showed a complete recovery of the axis of the lower limbs. In the initial stages, the presence of bone wax in the area of de-epiphysiodesis allowed for stabilization of the deformity on the 20° of preoperative valgus. The interpretation of the growth cartilage activity occurred in an asymmetrical way such as to realign the femoral load axis, it can be based on the different mechanical stimulus on the two knee areas due to the preexisting deformity. There is no unanimous evidence in the literature in terms of management of growth disorders resulting from this type of injury. Bone wax resulted in effectively filling the hole of de-epiphysiodesis in the distal femoral growth plate and allowed us to obtain the response of the growth plate and to improve the recovery time in young children.

Epidemiological Study of Lumbar Spinal Stenosis Symptoms: 10-Year Follow-Up in the Community.

BACKGROUND: Lumbar spinal stenosis (LSS) is one of the important health problems in an aging society because it can significantly impair quality of life (QOL) and active daily living (ADL). However, the natural history or long-term change of LSS symptoms is still unclear. The purpose of this study was to clarify the 10-year course of lumbar spinal stenosis (LSS) symptoms in community-dwelling residents of more than 1000 people with prospective data collection. METHODS: A total of 1149 subjects were analyzed for the time course of LSS symptoms for ten years. LSS symptoms were assessed using a questionnaire specially designed and validated to detect LSS symptoms without image information such as magnetic resonance imaging. RESULTS: The prevalence of positive LSS symptoms was about 16% in the initial survey and 10-year follow-up. Of the subjects who were LSS positive at the initial survey, 40% showed positive LSS symptoms at follow-up and 60% switched to negative LSS symptoms. According to the multivariable logistic regression analysis, severe depression and positive LSS symptoms were extracted as predictors of the presence of LSS symptoms after a 10-year follow-up. CONCLUSION: The statistical predictor of the presence of LSS symptoms at 10 years was the presence of LSS symptoms at the initial survey; however, 60% of those who were positive for LSS symptoms at the initial survey were not determined to have LSS symptoms at the 10-year follow-up. This was the same result as at the 1-year and 6-year follow-up.

A 43-Year Follow-Up of Unilateral Harrington Rod Instrumentation and Limited Fusion for Adolescent Idiopathic Scoliosis.

Limited unilateral instrumentation has been used in the past in the treatment of adolescent idiopathic scoliosis; however, to our knowledge, there are no reported cases with ultra-long follow up regarding this. Our objective is to report on the 43-year follow-up of limited Harrington rod instrumentation for the treatment of a double major adolescent idiopathic scoliosis curve. We describe the patient's initial presentation, including history, physical exam, radiographic findings and clinical decision-making. Initial coronal cobb angle measurements before surgery were: 14° T1-T5, 42° T5-T12, 44° T12-L4. At 43 years of follow up, there was progression (14°>24°, 42°>70°, 44°>50°) of the patient's double major scoliosis curve despite unilateral, limited Harrington rod instrumentation from L4-S1. The patient was treated with a T3-pelvis instrumentation and fusion and posterior column osteotomies. To our knowledge, this is the longest follow-up and subsequent revision of a patient undergoing limited, unilateral Harrington rod instrumented fusion for the treatment of a double major adolescent idiopathic scoliosis curve.

A phase I/II trial of intraoperative breast radiotherapy in an Asian population: 10-year results with critical evaluation.

Although phase III trials have been published comparing whole breast irradiation (WBI) with accelerated partial breast irradiation (APBI) using intraoperative radiotherapy (IORT), long-term follow-up results are lacking. We report the 10-year follow-up results of a prospective phase I/II clinical trial of IORT. The inclusion criteria were as follows: (i) tumor size <2.5 cm, (ii) desire for breast-conserving surgery, (iii) age >50 years, (iv) negative margins after resection and (v) sentinel lymph node-negative disease. A single dose of IORT (19-21 Gy) was delivered to the tumor bed in the operation room just after wide local excision of the primary breast cancer using a 6-12 MeV electron beam. Local recurrence was defined as recurrence or new disease within the treated breast and was evaluated annually using mammography and ultrasonography. A total of 32 patients were eligible for evaluation. The median patient age was 65 years and the median follow-up time was 10 years. Two patients experienced local recurrence just under the nipple, out of the irradiated field, after 8 years of follow-up. Three patients had contralateral breast cancer and one patient experienced bone metastasis after 10 years of follow-up. No patient experienced in-field recurrence nor breast cancer death. Eight patients had hypertrophic scarring at the last follow-up. There were no lung or heart adverse effects. This is the first report of 10-year follow-up results of IORT as APBI. The findings suggest that breast cancer with extended intraductal components should be treated with great caution.

Adjacent Segment Disease After Posterior Lumbar Interbody Fusion: A Case Series of 1000 Patients.

STUDY DESIGN: Retrospective study. OBJECTIVE: There have been few reports of adjacent segment disease (ASD) after posterior lumbar interbody fusion (PLIF) with large numbers and long follow-up. The purpose of this study was to investigate (1) ASD incidence and time periods after primary PLIF, (2) repeat ASD incidence and time periods, and (3) ASD incidence and time periods by fusion length, age, and preoperative pathologies. METHODS: A total of 1000 patients (average age 67 years, average follow-up 8.3 years) who underwent PLIF for degenerative lumbar disorders were reviewed. ASD was defined as a symptomatic condition in which revision surgery was required. RESULTS: The overall ASD rate was 9.0%, and the average ASD period was 4.7 years after primary surgery. With respect to clinical features of ASD, degenerative spondylolisthesis at the cranial fusion segment was the most frequent. In terms of repeat ASD, second and third ASD incidences were 1.1% and 0.4%, respectively. As for ASD by fusion length, age, and preoperative pathologies, ASD incidence was increased by fusion length, while the time period to ASD was significantly shorter in elderly patients and those with degenerative lumbar scoliosis. CONCLUSIONS: In the present study, the overall ASD incidence was 9.0%, and the average ASD period was 4.7 years after primary operation. Second and third ASD incidences were 1.1% and 0.4%, respectively. Fusion length affected the ASD incidence, while aging factor and preoperative pathology affected the ASD time period.

Serous Retinal Detachment in Dome-shaped Macula with 7 Years Follow-up.

Dome-shaped macula (DSM) was first described by Gaucher et al. as a convex protrusion of macula within a staphyloma in highly myopic eyes that cause visual impairment associated with serous foveal detachment (SFD). We describe a patient with persistent SFD in DSM documented by serial spectral domain optical coherence tomography for 7 years with stable vision.