Bortezomib may stabilize pediatric renal transplant recipients with antibody-mediated rejection

Background

Current therapeutic strategies to effectively treat antibody-mediated rejection (AMR) are insufficient. Thus, we aimed to determine the benefit of a therapeutic protocol using bortezomib for refractory C4d + AMR in pediatric kidney transplant patients.

Methods

We examined seven patients with treatment-refractory C4d + AMR. Immunosuppression included antithymocyte globulin or anti-CD25 monoclonal antibody for induction therapy with maintenance corticosteroids, calcineurin inhibitor, and anti-metabolite. Estimated glomerular filtration rate (eGFR) calculated by the Schwartz equation, biopsy findings assessed by 2013 Banff criteria, and human leukocyte antigen (HLA) donor-specific antibodies (DSA) performed using the Luminex single antigen bead assay were monitored pre- and post- bortezomib therapy.

Results

Seven patients (86 % male, 86 % with ≥6/8 HLA mismatch, and 14 % with pre-formed DSA) age 5 to 19 (median 15) years developed refractory C4d + AMR between 1 and 145 (median 65) months post-transplantation. All patients tolerated bortezomib. One patient had allograft loss. Of the six patients with surviving grafts (86 %), mean pre-bortezomib eGFR was 42 ml/min/1.73 m² and the mean 1 year post-bortezomib eGFR was 53 ml/min/1.73 m². Five of seven (71 %) had improvement of histological findings of AMR, C4d staining, and/or acute cellular rejection. Reduction in HLA DSAs was more effective for class I than class II.

Conclusions

Bortezomib appears safe and may correlate with stabilization of eGFR in pediatric kidney transplant patients with refractory C4d + AMR.

     

Association of C1q-fixing DSA with late graft failure in pediatric renal transplant recipients

Background

We investigated the prognostic value of overall and complement-binding donor-specific HLA antibodies (DSA) in pediatric patients undergoing clinically indicated graft biopsies and their association with graft outcome and specific histological lesions.

Methods

Sera of 62 patients at time of indication biopsy ≥1 year posttransplant were assessed for DSA and C1q-fixing DSA by single-antigen bead (SAB) technology.

Results

Twenty-six patients (42 %) were DSA-positive at time of indication biopsy and nine (15 %) were C1q-positive. At 4 years postbiopsy, patients with C1q-positivity had a low graft survival (11 %) compared to DSA-positive, C1q-negative patients (82 %, p?=?0.001) and to DSA-negative patients (88 %, p?<?0.001). The majority (89 %) of C1q-positive patients were diagnosed with active chronic antibody-mediated rejection (ABMR). C1q DSA-positivity [adjusted hazard ratio (HR) 6.35], presence of transplant glomerulopathy (HR 9.54), and estimated glomerular filtration rate (eGFR) at the time of indication biopsy (HR 0.91) were risk factors for subsequent graft loss.

Conclusions

The presence of C1q-positive DSA in the context of an indication biopsy identifies a subgroup of pediatric renal transplant recipients with a markedly increased risk of subsequent graft loss. Because a fraction of DSA-positive patients escape rejection or graft dysfunction, the C1q assay increases the specificity of a positive DSA result regarding unfavorable transplant outcome.

     

Results of a multicenter prospective clinical study in Japan for evaluating efficacy and safety of desensitization protocol based on rituximab in ABO-incompatible kidney transplantation

Background

Deceased organ donations are rare in Japan, with most kidney transplants performed from a limited number of living donors. Researchers have thus developed highly successful ABO-incompatible transplantation procedures, emphasizing preoperative desensitization and postoperative immunosuppression. A recent open-label, single-arm, multicenter clinical study prospectively examined the efficacy and safety of rituximab/mycophenolate mofetil desensitization in ABO-incompatible kidney transplantation without splenectomy.

Methods

Mycophenolate mofetil and low dose steroid were started 28 days pretransplant, followed by two doses of rituximab 375 mg/m² at day ?14 and day ?1, and postoperative immunosuppression with tacrolimus or ciclosporin and basiliximab. The primary endpoint was the non-occurrence rate of acute antibody-mediated rejection. Patient survival and graft survival were monitored for 1 year posttransplant.

Results

Eighteen patients received rituximab and underwent ABO-incompatible kidney transplantation. CD19-positive peripheral B cell count decreased rapidly after the first rituximab infusion and recovered gradually after week 36. The desensitization protocol was tolerable, and most rituximab-related infusion reactions were mild. No anti-A/B antibody-mediated rejection occurred with this series. One patient developed anti-HLA antibody-mediated rejection (Banff 07 type II) on day 2, which was successfully managed. Patient and graft survival were both 100 % after 1 year.

Conclusion

Our desensitization protocol was confirmed to be clinically effective and with acceptable toxicities for ABO-I-KTx (University Hospital Medical Information Network Registration Number: UMIN000006635).

     

Death and kidney allograft dysfunction after bacteremia

Background

Some studies have reported causal associations between bacteremia and mortality or allograft loss in kidney transplant recipients (KTR). However, few studies have assessed the clinical course of kidney function and the risk of acute allograft rejection after bacteremia.

Methods

We retrospectively reviewed 902 kidney transplants performed at Nagoya Daini Red Cross Hospital between January 1, 2002 and March 31, 2014. Forty-five living donor kidney transplant recipients with single bacteremia were included. We analyzed death, change in kidney function, and development of acute allograft rejection 12 months after bacteremia according to the following groups: primary source of bacteremia (urinary tract or other sources), site of acquisition (community acquired or nosocomial), severity (not meeting the systemic inflammatory response syndrome criteria and sepsis or severe sepsis and septic shock), empiric antibiotic use (appropriate or inappropriate), and baseline kidney function (estimated glomerular filtration rate ≤44.7 or ≥44.8 ml/min).

Results

Urinary tract infection (UTI) was the leading cause of bacteremia (68.9 %), and Escherichia coli was the most common pathogen. Three cases (6.7 %) died of infection that caused bacteremia within 12 months. Pneumonia accounted for two-thirds. Kidney function declined 1 week after bacteremia (P < 0.05), particularly in severe cases. Thereafter, kidney function was comparable to baseline level in each group (P ≥ 0.05). Severe UTI was associated with subsequent acute allograft rejection (P = 0.03).

Conclusions

Pneumonia in KTR should be managed with caution. Kidney function generally returned to baseline level after bacteremia. However, severe UTI may be associated with subsequent acute allograft rejection.

     

Treatment of HCV in renal transplant patients with peginterferon and ribavirin: long-term follow-up

Background

In addition to the observation of an increased viremia among patients with chronic hepatitis C virus (HCV) infection who undergo renal transplantation, fibrosis and necroinflammatory activity have been noted to worsen comparing pre- and post-renal transplantation liver biopsies in some of these patients. Apart from the reported reduced patient and allograft survival rates, post-transplant diabetes mellitus, de novo glomerulonephritis, and an increased overall risk of infection have been observed. However, antiviral therapy for HCV is generally considered contraindicated among patients with solid organ transplants, with the main worry being the risk of acute rejection in relation to the use of interferon. We reported the long-term outcome of four renal transplant patients with chronic HCV infection who received peginterferon-based therapy.

Methods

We collected the long-term follow-up data of four patients who completed the therapy with peginterferon in combination with ribavirin. Two of them had renal impairment at baseline.

Results

With treatment, they had a significant improvement in terms of serum liver transaminase level, and two patients achieved the early virological response and the other two rapid virological response. All four patients achieved sustained virological response, with neither HCV flare up nor renal dysfunction during follow-up for a mean duration of 74.3 months after therapy.

Conclusions

These results suggest that sustained HCV virological response may be achieved without allograft dysfunction, in selected renal transplant patients using a peginterferon-based therapy.

     

Allograft augmentation in proximal humerus fractures

Objective

Achieve stable fixation to initially start full range of motion (ROM) and to prevent secondary displacement in unstable fracture patterns and/or weak and osteoporotic bone.

Indications

(Secondarily) displaced proximal humerus fractures (PHF) with an unstable medial hinge and substantial bony deficiency, weak/osteoporotic bone, pre-existing psychiatric illnesses or patient incompliance to obey instructions.

Contraindications

Open/contaminated fractures, systemic immunodeficiency, prior graft-versus-host reaction.

Surgical technique

Deltopectoral approach. Identification of the rotator cuff. Disimpaction and reduction of the fracture, preparation of the situs. Graft preparation. Allografting. Fracture closure. Plate attachment. Definitive plate fixation. Radiological documentation. Postoperative shoulder fixation (sling).

Postoperative management

Cryotherapy, anti-inflammatory medication on demand. Shoulder sling for comfort. Full active physical therapy as tolerated without pain. Postoperative radiographs (anteroposterior, outlet, and axial [as tolerated] views) and clinical follow-up after 6 weeks and 3, 6, and 12 months.

Results

Bony union and allograft incorporation in 9 of 10 noncompliant, high-risk patients (median age 63 years) after a mean follow-up of 28.5 months. The median Constant–Murley Score was 72.0 (range 45–86). Compared to the uninjured contralateral side, flexion was impaired by 13?%, abduction by 14?%, and external rotation by 15?%. Mean correction of the initial varus displacement was 38° (51° preoperatively to 13° postoperatively).

     

Quantifying Massive Allograft Healing of the Canine Femur In Vivo and Ex Vivo: A Pilot Study

Background

Allograft integration in segmental osseous defects is unpredictable. Imaging techniques have not been applied to investigate angiogenesis and bone formation during allograft healing in a large-animal model.

Questions/purposes

We used dynamic contrast-enhanced (DCE)-MRI and cone beam (CB)-CT to quantify vascularity and bone volume in a canine femoral allograft model and determined their relationship with biomechanical testing and histomorphometry.

Methods

Femoral ostectomy was performed in three dogs and reconstructed with a 5-cm allograft and compression plate. At 0.5, 3, and 6 months, we performed DCE-MRI to quantify vascular permeability (Ktrans) and perfused fraction and CB-CT to quantify bone volume. We also performed posteuthanasia torsional testing and dynamic histomorphometry of the grafted and nonoperated femurs.

Results

DCE-MRI confirmed the avascular nature of allograft healing (perfused fraction, 2.08%–3.25%). CB-CT demonstrated new bone formation at 3 months (26.2, 3.7, and 2.2 cm³) at the graft-host junctions, which remodeled down at 6 months (14.0, 2.2, and 2.0 cm³). The increased bone volume in one subject was confirmed with elevated Ktrans (0.22) at 3 months. CB-CT-identified remodeled bone at 6 months was corroborated by histomorphometry. Allografted femurs recovered only 40% of their strength at 6 months.

Conclusions

CB-CT and DCE-MRI can discriminate differences in angiogenesis and bone formation in the canine allograft model, which has potential to detect a small (32%) drug or device effect on biomechanical healing with only five animals per group.

Clinical Relevance

These radiographic tools may have the potential to assess adjuvant effects on vascular invasion and new bone formation after segmental allograft transplantation.

     

Autograft versus allograft reconstruction of acute tibial plateau fractures: a comparative study of complications and outcome

Background

There is no consensus regarding the use of filling agent in the re-elevation of depressed tibial plateau fracture (TPF). Although autograft is considered as the gold standard approach of such reconstructions, its limitation has led to a recent attraction toward allograft substitution. In this study, we compare the complications and outcome of autograft and allograft in TPF reconstruction, in order to address the existing controversy.

Materials and methods

A total of 81 patients with acute TPF were included in this study. Allograft and autograft were applied in 58 and 23 cases, respectively. The mean age of the patients was 40.26 years, and the mean follow-up period of patients was 19.1 months. Clinical and radiological assessment of the outcome was conducted, employing the modified Rasmussen clinical criteria.

Results

A total of three infections were observed in our patients, from which two infections occurred in allograft received patients. Articular surface collapse was seen in two cases, including one allograft and one autograft receiving patient. The mean clinical score was 18.65 and 18.55 in autograft and allograft received patients, respectively (p = 0.09). The mean radiological score was 15.65 and 15.68 in autograft and allograft received patients (p = 0.3).

Conclusion

With respect to the comparable complication rate, clinical and radiological outcome of allogenic versus autologous reconstruction of TPF, freeze-dried allograft could be recommended as an appropriate substitute of autograft in this treatment. Nevertheless, the longer follow-up period of the patients could further extend our understanding of the clinical outcome of each component.

     

Large diaphyseal-incorporating allograft prosthetic composites: when,how, and why

Background

Proximal humeral bone loss in shoulder arthroplasty is a complex problem with a heterogeneous presentation. Different etiologies may contribute to varying degrees of severity in bone loss that dictate different treatment approaches.

Objectives

The purpose of this is article is to describe our technique for treatment of proximal humeral bone loss with proximal humeral allograft prosthetic composites (APC) and identify factors that may predict when larger allografts may be necessary.

Materials and methods

Ninety-nine patients were identified that had undergone reverse total shoulder arthroplasty with use of a proximal humeral allograft. Thirty-nine of these had large allografts that involved a significant portion of the diaphysis. Preoperative characteristics were examined to identify factors that may be associated with use of a larger diaphyseal-incorporating allograft.

Results

Well-fixed humeral stems could be treated with short metaphyseal allografts in 55 of 65 (85%) cases. Loose stems required longer diaphyseal-incorporating allografts in 28 of 31 (90%) cases, and these were commonly associated with periprosthetic fractures (n = 10), failed prior APC (n = 6), and infection (n = 5). Noncemented stems required diaphyseal grafts in 75% of cases, compared to cemented stems which required larger grafts in 34% of cases.

Conclusions

Proximal humeral bone loss in the setting of revision shoulder arthroplasty can be successfully managed with a reverse total shoulder and proximal humeral allograft. Larger allografts are frequently required for loose humeral stems, and noncemented stems appear more likely to require larger allografts than cemented stems.

     

Clip ligation of unruptured intracranial aneurysms: a prospective midterm outcome study

Background

We conducted a prospective study to investigate the clinical and radiological outcome in a surgical case series of 176 patients with 203 unruptured intracranial aneurysms (UIA).

Methods

The success of aneurysm obliteration was assessed within 2 weeks after surgery by digital subtraction angiography (DSA). Patients also underwent angiography 5 years after surgery. Clinical outcomes were assessed using the modified Rankin Scale (mRS). All predictors of poor surgical outcomes were assessed using an exact logistic regression.

Results

Overall, 83 % of the patients had a good outcome (mRS score 0 or 1); 10.8 % of the patients had a slight disability (mRS score 2), and 6.2 % of the patients had a moderate or moderate-severe disability (mRS score 3 or 4). The mortality rate was 0 % overall. The most important predictors of outcome were presence of history of ischemic cerebrovascular disease and postoperative stroke. Complete aneurysm occlusion was achieved in 93.5 % of all aneurysms. Sixty percent of treated aneurysms were checked with late follow-up DSA. No cases of hemorrhage from a surgically obliterated UIA were documented in this series during the 7.3?±?1.4 (SD)-year follow-up period.

Conclusions

If patients are carefully selected and individually assigned to their optimum treatment modality, IUAs can be obliterated by surgery with a low percentage of unfavorable outcomes.

     

Surgical Revascularization Induces Angiogenesis in Orthotopic Bone Allograft

Background

Remodeling of structural bone allografts relies on adequate revascularization, which can theoretically be induced by surgical revascularization. We developed a new orthotopic animal model to determine the technical feasibility of axial arteriovenous bundle implantation and resultant angiogenesis.

Questions/purposes

We asked whether arteriovenous bundles implanted in segmental allografts would increase cortical blood flow and angiogenesis compared to nonrevascularized frozen bone allografts and contralateral femoral controls.

Methods

We performed segmental femoral allotransplantation orthotopically from 10 Brown Norway rats to 20 Lewis rats. Ten rats each received either bone allograft reconstruction alone (Group I) or allograft combined with an intramedullary saphenous arteriovenous flap (Group II). At 16 weeks, we measured cortical blood flow with the hydrogen washout method. We then quantified angiogenesis using capillary density and micro-CT vessel volume measurements.

Results

All arteriovenous bundles were patent. Group II had higher mean blood flow (0.12 mL/minute/100 g versus 0.05 mL/minute/100 g), mean capillary density (23.6% versus 2.8%), and micro-CT vessel volume (0.37 mm³ versus 0.07 mm³) than Group I. Revascularized allografts had higher capillary density than untreated contralateral femora, while vessel volume did not differ and blood flow was lower.

Conclusions

Axial surgical revascularization in orthotopic allotransplants can achieve strong angiogenesis and increases cortical bone blood flow.

Clinical Relevance

Poor allograft revascularization results in frequent complications of nonunion, infection, and late stress fracture. The presented technique of surgical revascularization could therefore offer a beneficial adjunct to clinical segmental bone allografting.

     

The impact of socioeconomic status and geographic remoteness on access to pre-emptive kidney transplantation and transplant outcomes among children

Background

Low socioeconomic status (SES) and geographic disparity have been associated with worse outcomes and poorer access to pre-emptive transplantation in the adult end-stage kidney disease (ESKD) population, but little is known about their impact in children with ESKD. The aim of our study was to determine whether access to pre-emptive transplantation and transplant outcomes differ according to SES and geographic remoteness in Australia.

Methods

Using data from the Australia and New Zealand Dialysis and Transplant Registry (1993–2012), we compared access to pre-emptive transplantation, the risk of acute rejection and graft failure, based on SES and geographic remoteness among Australian children with ESKD (≤18 years), using adjusted logistic and Cox proportional hazard modelling.

Results

Of the 768 children who commenced renal replacement therapy, 389 (50.5 %) received living donor kidney transplants and 28.5 % of these (111/389) were pre-emptive. There was no significant association between SES quintiles and access to pre-emptive transplantation, acute rejection or allograft failure. Children residing in regional or remote areas were 35 % less likely to receive a pre-emptive transplant compared to those living in major cities [adjusted odds ratio (OR) 0.65, 95 % confidence interval (CI) 0.45–1.0]. There was no significant association between geographic disparity and acute rejection (adjusted OR 1.03, 95 % CI 0.68–1.57) or graft loss (adjusted hazard ratio 1.05, 95 % CI 0.74–1.41).

Conclusions

In Australia, children from regional or remote regions are much less likely to receive pre-emptive kidney transplantation. Strategies such as improved access to nephrology services through expanding the scope of outreach clinics, and support for regional paediatricians to promote early referral may ameliorate this inequity.

     

Laparoscopic inguinal hernioplasty after robot-assisted laparoscopic radical prostatectomy

Purpose

To evaluate the efficacy and safety of laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair in patients who have undergone robot-assisted laparoscopic radical prostatectomy (RALP).

Methods

From July 2014 to December 2016, TAPP inguinal hernia repair was conducted in 40 consecutive patients who had previously undergone RALP. Their data were retrospectively analyzed as an uncontrolled case series.

Results

The mean operation time in patients who had previously undergone RALP was 99.5 ± 38.0 min. The intraoperative blood loss volume was small, and the duration of hospitalization was 2.0 ± 0.5 days. No intraoperative complications or major postoperative complications occurred. During the average 11.2-month follow-up period, no patients who had previously undergone prostatectomy developed recurrence.

Conclusions

Laparoscopic TAPP inguinal hernia repair after RALP was safe and effective. TAPP inguinal hernia repair may be a valuable alternative to open hernioplasty.

     

No difference in flexion power despite iliopsoas fatty degeneration in healed hip fractures with large lesser trochanter displacement

Objective

To evaluate iliopsoas atrophy and loss of function after displaced lesser trochanter fracture of the hip.

Design

Cohort study.

Setting

District hospital.

Patients

Twenty consecutive patients with pertrochanteric fracture and displacement of the lesser trochanter of?>?20 mm.

Intervention

Fracture fixation with either an intramedullary nail or a plate.

Outcome measurements

Clinical scores (Harris hip, WOMAC), hip flexion strength measurements, and magnetic resonance imaging findings.

Results

Compared with the contralateral non-operated side, the affected side showed no difference in hip flexion force in the supine upright neutral position and at 30° of flexion (205.4 N vs 221.7 N and 178.9 N vs. 192.1 N at 0° and 30° flexion, respectively). However, the affected side showed a significantly greater degree of fatty infiltration compared with the contralateral side (global fatty degeneration index 1.085 vs 0.784), predominantly within the psoas and iliacus muscles.

Conclusion

Severe displacement of the lesser trochanter (>?20 mm) in pertrochanteric fractures did not reduce hip flexion strength compared with the contralateral side. Displacement of the lesser trochanter in such cases can lead to fatty infiltration of the iliopsoas muscle unit. The amount of displacement of the lesser trochanter did not affect the degree of fatty infiltration.

Level of evidence

II.

     

Irradiation Does Not Modify Mechanical Properties of Cancellous Bone Under Compression

Background

Gamma radiation sterilization can make cortical bone allograft more brittle, but whether it influences mechanical properties and propensity to form microscopic cracks in structurally intact cancellous bone allograft is unknown.

Questions/purposes

We therefore determined the effects of gamma radiation sterilization on structurally intact cancellous bone mechanical properties and damage formation in both low- and high-density femoral cancellous bone (volume fraction 9%–44%).

Methods

We studied 26 cancellous bone cores from the proximal and distal femurs of 10 human female cadavers (49–82 years of age) submitted to a single compressive load beyond yield. Mechanical properties and the formation of microscopic cracks and other tissue damage (identified through fluorochrome staining) were compared between irradiated and control specimens.

Results

We observed no alterations in mechanical properties with gamma radiation sterilization after taking into account variation in specimen porosity. No differences in microscopic tissue damage were observed between the groups.

Conclusions

Although gamma radiation sterilization influences the mechanical properties and failure processes in cortical bone, it does not appear to influence the performance of cancellous bone under uniaxial loading.

Clinical Relevance

Our observations support the use of radiation sterilization on structurally intact cancellous bone allograft.

     

Task Shifting: The Use of Laypersons for Acquisition of Vital Signs Data for Clinical Decision Making in the Emergency Room Following Traumatic Injury

Importance

In resource-limited settings, identification of successful and sustainable task-shifting interventions is important for improving care.

Objective

To determine whether the training of lay people to take vital signs as trauma clerks is an effective and sustainable method to increase availability of vital signs in the initial evaluation of trauma patients.

Design

We conducted a quasi-experimental study of patients presenting with traumatic injury pre- and post-intervention.

Setting

The study was conducted at Kamuzu Central Hospital, a tertiary care referral hospital, in Lilongwe, Malawi.

Participants

All adult (age ≥ 18 years) trauma patients presenting to emergency department over a six-month period from January to June prior to intervention (2011), immediately post-intervention (2012), 1 year post-intervention (2013) and 2 years post-intervention (2014).

Intervention

Lay people were trained to take and record vital signs.

Main outcomes and measures

The number of patients with recorded vital signs pre- and post-intervention and sustainability of the intervention as determined by time-series analysis.

Results

Availability of vital signs on initial evaluation of trauma patients increased significantly post-intervention. The percentage of patients with at least one vital sign recorded increased from 23.5 to 92.1%, and the percentage of patients with all vital signs recorded increased from 4.1 to 91.4%. Availability of Glasgow Coma Scale also increased from 40.3 to 88.6%. Increased documentation of vital signs continued at 1 year and 2 years post-intervention. However, the percentage of documented vital signs did decrease slightly after the US-trained medical student and surgeon who trained the trauma clerks were no longer available in country, except for Glasgow Coma Scale. Patients who died during emergency department evaluation were significantly less likely to have vital signs recorded.

Conclusions and relevance

The training of lay people to collect vital signs and Glasgow Coma Scale is an effective and sustainable method of task shifting in a resource-limited setting.

     

Subcutaneous dissection area contributes less to endoscopic thyroidectomy-related invasiveness

Objective

To clarify the contribution of the subcutaneous area during breast approach endoscopic thyroidectomy (BAET), with regard to invasiveness-related outcomes.

Methods

Seventy-two patients were randomly assigned to two groups: standard dissection and limited dissection. Postoperative pain and inflammatory response were compared between groups.

Results

The groups were well matched except for subcutaneous dissection area (137.11 ± 21.10 vs. 83.69 ± 12.10 cm², p < 0.0001). No significant difference was found with regard to VAS score and postoperative inflammatory response.

Conclusion

Our RCT indicated that the subcutaneous area plays a less important role with regard to BAET-related postoperative pain.

     

Revision shoulder arthroplasty with a reverse shoulder prosthesis

Introduction

Revision shoulder arthroplasty presents many unique and complex challenges when glenoid bone loss is involved. A distorted and medialized anatomy prevents the proper mechanics of the reverse prosthesis with regard to deltoid tension and ultimate function. This paper highlights one surgeon’s experience using structural allograft for glenoid bone loss.

Patients and methods

In all, 20 patients for a total of 24 surgeries with a medialized glenoid and/or substantial glenoid bone loss of grade IIB or higher were evaluated in this retrospective study. The allograft surgeries were performed as a one-stage procedure except for three patients. Recombinant human bone morphogenetic protein-2 (BMP2) was added to supplement incorporation in all cases. Four patients had two separate allograft procedures. Eight of the allograft procedure were femoral shaft, eleven of the allografts were femoral neck/head, and five of the allograft procedures were from proximal humerus. A graft was considered a success if they had at least 12 months of clinical and radiographic follow-up without subsequent removal of the graft or radiographic failure. Patients with less than 12 months of follow-up were included if the graft was removed or had early failure.

Results

All femoral shaft allografts except one failed, and during revision surgery it was often noted that the graft was cracked where the peripheral screws had been drilled. In nine patients the graft was still in place at last follow-up, seven of these were femoral neck/head allografts. Five grafts were removed secondary to infection. Average follow-up was 24 months (range 5–45 months).

Conclusions

Femoral neck allografts are an option in patients with substantial bone loss. The authors do not recommend use of femoral shaft allografts.

     

Prostatic injection of botulinum toxin is not inferior to optimized medical therapy in the management of lower urinary tract symptoms due to benign prostatic hyperplasia: results of a randomized clinical trial

Objective

To explore efficacy and safety of Botulinum Neurotoxin Type A (BoNT-A) prostatic injection in patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperperplasia.

Materials and methods

A phase 3 multicenter open-labeled study randomised patients to receive BoNT-A prostatic injection or optimized medical therapy. BoNT-A injection consisted in trans-rectal injections of 200 UI in the transitional zone of the prostate. Optimal medical therapy consisted in oral medication with any drug patented for LUTS. One month (M1) after randomisation patients in the BoNT-A group were asked to stop any medical therapy related to LUTS. The main judgment criterion was the IPSS score at M4. Per-protocol analysis was performed with a non-inferiority hypothesis (ΔIPSS < 3).

Results

127 patients were randomised to BoNT-A (n = 64) or medical therapy (n = 63). At randomisation mean IPSS was 16.9 ± 7.2 in the BoNT-A group vs 15.7 ± 7.3 in control. In the BoNT-A group, 44 patients (73.3%) could interrupt medical therapy for LUTS from M1 to M4. At M4, mean IPSS score was 12.0 ± 6.7 in the BoNT-A group vs 11.8 ± 6.9 in control. After adjustment for baseline IPSS, delta IPSS between groups was 0.01; 95% CI [? 2.14; 2.11] leading to accept the non-inferiority hypothesis.

Conclusions

Four months after BoNT-A injection, most of the patients could interrupt LUTS-related medical treatments. In these patients, IPSS improvement was not inferior to optimized medical treatment, but the study design did not allow to conclude that this improvement was related with study drug rather than with sustained placebo effect.

Trial registration

NCT01275521

     

A simplified surgical technique for recurrent inguinal hernia repair following total extraperitoneal patch plastic

Purpose

To present a new and alternative method for surgical treatment of recurrent inguinal hernia after total extraperitoneal patch plastic (TEP).

Methods

From January 2005 to September 2015, 35 patients (34 male, 1 female; mean age 65 ± 12.6 years) with recurrent inguinal hernia following TEP were operated at the Kliniken Essen-Mitte using a simplified method consisting of re-fixation of the primary mesh to the inguinal ligament by an anterior approach.

Results

The mean operating time was 47 ± 22 min. All complications were minor with an overall incidence of 6%. After a mean follow-up of 54 months one re-recurrence was observed.

Conclusions

This Simplified Hernia Repair is safe and avoids additional foreign body implantation. Therefore, it is our method of choice for recurrent inguinal hernias after TEP.