Significant Difference In Failure Rate Research Articles

A Randomized Controlled Trial of Novel Loop Drainage Technique Versus Standard Incision and Drainage in the Treatment of Skin Abscesses.

The objective was to compare the failure rate of incision and drainage (I&D) with LOOP technique versus I&D with standard packing technique in adults and children presenting to the emergency department (ED) with subcutaneous abscess. This prospective, randomized controlled trial (NCT03398746) enrolled a convenience sample of patients presenting to two Level 1 trauma centers over 12months with skin abscesses. Of 256 patients screened, 217 patients were enrolled, 109 randomized to I&D with packing (50%) and 108 (50%) to I&D with LOOP. The primary outcome was treatment failure defined by admission, IV antibiotics, or repeat drainage within 10-day follow-up. The secondary outcomes included ease of procedure, ease of care, pain, and satisfaction using a 10-point numeric rating scale. There were no differences in patient characteristics between groups. Follow-up data were available in 196 (90%). Treatment failure occurred in 20% (range= 12%-28%) of packing patients and 13% (range= 6%-20%) of LOOP patients (p=0.25). There were no significant differences in failure rates in adults (p=0.82), but there was a significant difference in children (age ≤ 18 years) at 21% (range = 8%-34%) in the packing group and 0 (0%) in the LOOP group (p=0.002). Operators reported no significant differences in ease of procedure between techniques (p=0.221). There was significantly less pain at follow-up in the LOOP group versus packing (p=0.004). The wound was much easier to care for over the first 36hours in the LOOP group (p=0.002). Patient satisfaction at 10days postprocedure was significantly higher in the LOOP group (p=0.005). The LOOP and packing techniques had similar failure rates for treatment of subcutaneous abscesses in adults, but the LOOP technique had significantly fewer failures in children. Overall, pain and patient satisfaction were significantly better in patients treated using the LOOP technique.

Negative Roche cobas HPV testing in cases of biopsy-proven invasive cervical carcinoma, compared with Hybrid Capture 2 and liquid-based cytology

The objective of this study was to conduct a retrospective analysis of results of cytology and Roche cobas (RC) and Hybrid Capture 2 (HC2) human papillomavirus (HPV) screening tests in cases of biopsy-proven invasive cervical carcinoma. The clinical data were obtained at a university hospital in New York, NY, between 2004 and 2017. Results of cytology, reported per Bethesda classification system, and HPV screening in 177 identified cases with cytology and biopsy-proven diagnosis of cervical carcinoma were included in the analysis. Two cohorts were analyzed. Of the 177 identified cases, cotesting was performed for 100 patients. Among these 100, cotesting screening results would not trigger immediate colposcopy in 6%; HPV screening results were reported as negative in 16% (16% of all RC, 16% of all HC2, 16% total) and, if HPV was the only screening modality, would not trigger a colposcopy. Of the 177 total cases, 128 patients underwent cytology screening prior to biopsy, with a cytology diagnosis that, alone, would not trigger immediate colposcopy in 14%. The HPV DNA screening and cytology screening alone were negative for 16% and 14%, respectively, of patients with biopsy-proven diagnoses of invasive carcinoma of cervical origin, without a significant difference in failure rates between cytology, HC2, and RC. The cotesting approach had a significantly lower failure rate (6%) compared with the 2 other screening modalities alone.

Postoperative delayed trapped temporal horn in patients with lateral ventricular trigone meningioma: Risk factors, surgical management, and literature review

ObjectTo assess the risk factors for and surgical treatment of delayed trapped temporal horn (dTTH) in patients who had undergone removal of lateral ventricular trigone meningioma. MethodPatients with lateral ventricular trigone meningioma treated at our institution from 2011 to 2015 were identified. Predictors for dTTH were determined using logistic regression. Literature review and pooled analysis were also conducted to evaluate the comparative effectiveness of surgical treatment for dTTH. ResultsA total of 110 cases were included in the analysis. Thirteen (11.8%) cases developed dTTH following surgery. Multivariable logistic regression demonstrated an association of longer operative duration with higher incidence of dTTH (OR, 1.34; 95% CI, 1.00–1.80; p = 0.049). As surgical duration prolonged from less than 3 hours to 5 hours or more, the incidence of dTTH increased in a consistent, linear fashion from 7.7% to 13.9% (p = 0.03). Six cases (46.2%, 6/13) of dTTH underwent surgical treatment for their life-threatening symptoms. Seven studies including 13 cases of dTTH in the literature were identified. Literature data, including the current series, revealed a total of 24 procedures were performed in 19 cases. Endoscopic fenestration trended toward fewer complications than shunt (7.7% vs 25.0%, p = 0.530). There were no significant differences in failure rates between the two groups (23.1% vs 25.0%, p = 1.000). ConclusionPatients with prolonged operative duration may be at higher risk of dTTH. Endoscopic fenestration is considered in preference to shunt placement, since it possesses equivalent success rates with fewer complications and avoids the need for a permanent implant.

All-Inside Repair of Bucket-Handle Meniscal Tears: Clinical Outcomes and Prognostic Factors

Background: There is no consensus on technique of choice for repair of bucket-handle meniscal tears (BHMTs). Purpose: To determine factors that affect patient outcomes and failure rates in patients undergoing all-inside repairs of BHMTs. Study Design: Systematic review. Methods: A systematic review of 3 databases using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines was performed. All English-language literature from 1993 to 2019 describing clinical outcomes for patients undergoing all-inside BHMT repair with ≥12-month follow-up was reviewed by 2 independent reviewers. Patient characteristics (patient sex, age), intraoperative factors (laterality, concomitant procedures, surgical technique, implants utilized), and postoperative outcomes (failure rates) were analyzed. Study quality was evaluated with the Modified Coleman Methodology Score (MCMS). Results: Fifteen studies (1 level 1, 4 level 3, 10 level 4) with 763 total patients (64% male; average age, 26.4 years [range, 9-58 years]; average follow-up, 39.8 months [range, 12-120 months]) including 396 all-inside BHMT repairs were included. Six devices were used for repair including the Meniscal Repair System, FasT-Fix, Meniscus Arrow, Biofix Arrow, RapidLoc device, and PDS II suture, with failure rates of 13.5%, 22.4%, 27.1%, 42.9%, 45.2%, and 0%, respectively. The overall repair failure rate was 29.3% at an average of 13.0 months (range, 5.0-32.4 months), but 19.0% for devices still in use. The RapidLoc and Biofix Arrow had higher failure rates than other devices (P = .0003). Women (31%) were less likely to experience a failure than were men (69%) (P = .03). Longer follow-up duration resulted in higher failure rates (>30 months, 34.4%; <30 months, 23.4%; P = .016). In 4 studies reporting on both all-inside and inside-out repairs, no significant differences in failure rates were observed. No significant differences in failure rates were found between medial and lateral repairs nor repair with and without concurrent anterior cruciate ligament reconstruction (P > .05 for all). The overall average MCMS was 54.4 ± 12. Conclusion: The overall failure rate after all-inside repair of BHMTs is 29.3% at an average of 13.0 months, with no difference in failure rates between medial and lateral meniscal repairs. The variables shown to negatively affect the failure rates were the RapidLoc and Biofix Arrow, male sex, and longer follow-up duration.

Loosening and revision rates after total shoulder arthroplasty: a systematic review of cemented all-polyethylene glenoid and three modern designs of metal-backed glenoid

BackgroundSeveral modern designs of metal-backed glenoids (MBG) have been devised to overcome flaws such as loosening and a high failure rate. This review aimed to compare rates of complications and revision surgeries between cemented polyethylene glenoid (PEG) and three examples of modern MBG designs.MethodsLiterature search was carried out using PubMed, Cochrane Library, EMBASE, and Google Scholar using MeSH terms and natural keywords. A total of 1186 articles were screened. We descriptively analyzed numerical data between the groups and statistically analyzed the categorical data, such as the presence of radiolucent line, loosening, and revision surgery (failure). Articles were divided into three groups based on follow-up duration: < 36-month, 36–72-month, and > 72-month subgroups.ResultsThis study included 35 articles (3769 shoulders); 25 on cemented PEG and ten on the modern MBG. Mean age was 66.4 (21–93) and 66.5 years (31–88). The mean duration of follow-up was 73.1 (12–211) and 56.1 months (24–100). Overall, the rate of the radiolucent line was 354/1302 (27%) and 47/282 (17%), the loosening rate was 465/3185 (15%) and 22/449 (5%), and the failure rate was 189/3316 (6%) and 11/457 (2%), for PEG and MBG, respectively. The results of < 36-month and 36–72-month subgroups showed lower rates of radiolucency and loosening in the cemented PEG group, but there was no significant difference in failure rate (P = 0.754 and 0.829, respectively). In the > 72-month subgroup, MBG was better in terms of loosening (P < 0.001) and failure rates (P = 0.006).ConclusionsThe modern MBG component, especially TM glenoid, seems to be a promising alternative to cemented PEGs, based on subgroup revision rates according to the follow-up duration and overall results of ROM and clinical scores. All polyethylene glenoids tend to increase loosening and failure over time. Three modern MBG designs seem to have no difference in failure, at least in the < 36-month and 36–72-month subgroups compared to the cemented PEG. More long-term follow-up studies on modern MBG should be ultimately conducted.Level of evidenceLevel IV, systematic review.

Ibuprofen for the treatment of patent ductus arteriosus in preterm or low birth weight (or both) infants.

Background Indomethacin is used as standard therapy to close a patent ductus arteriosus (PDA) but is associated with reduced blood flow to several organs. Ibuprofen, another cyclo-oxygenase inhibitor, may be as effective as indomethacin with fewer adverse effects. Objectives To determine the effectiveness and safety of ibuprofen compared with indomethacin, other cyclo-oxygenase inhibitor, placebo or no intervention for closing a patent ductus arteriosus in preterm, low birth weight, or preterm and low birth weight infants. Search methods We searched The Cochrane Library, MEDLINE, EMBASE, Clincialtrials.gov, Controlled-trials.com, and www.abstracts2view.com/pas in May 2014. Selection criteria Randomised or quasi-randomised controlled trials of ibuprofen for the treatment of a PDA in newborn infants. Data collection and analysis Data collection and analysis conformed to the methods of the Cochrane Neonatal Review Group. Main results We included 33 studies enrolling 2190 infants. Two studies compared intravenous (iv) ibuprofen versus placebo (270 infants). In one study (134 infants) ibuprofen reduced the incidence of failure to close a PDA (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.51 to 0.99; risk difference (RD) -0.18, 95% CI -0.35 to -0.01; number needed to treat for an additional beneficial outcome (NNTB) 6, 95% CI 3 to 100). In one study (136 infants), ibuprofen reduced the composite outcome of infant mortality, infants who dropped out, or infants who required rescue treatment (RR 0.58, 95% CI 0.38 to 0.89; RD -0.22, 95% CI -0.38 to -0.06; NNTB 5, 95% CI 3 to 17). One study (64 infants) compared oral ibuprofen with placebo and noted a significant reduction in failure to close a PDA (RR 0.26, 95% CI 0.11 to 0.62; RD -0.44, 95% CI -0.65 to -0.23; NNTB 2, 95% CI 2 to 4). Twenty-one studies (1102 infants) reported failure rates for PDA closure with ibuprofen (oral or iv) compared with indomethacin (oral or iv). There was no significant difference between the groups (typical RR 1.00, 95% CI 0.84 to 1.20; I2 = 0%; typical RD 0.00, 95% CI -0.05 to 0.05; I2 = 0%). The risk of developing necrotising enterocolitis (NEC) was reduced for ibuprofen (16 studies, 948 infants; typical RR 0.64, 95% CI 0.45 to 0.93; typical RD -0.05, 95% CI -0.08 to -0.01; NNTB 20, 95% CI 13 to 100; I2 = 0% for both RR and RD). The duration of ventilatory support was reduced with ibuprofen (oral or iv) compared with iv or oral indomethacin (six studies, 471 infants; mean difference (MD) -2.4 days, 95% CI -3.7 to -1.0; I2 = 19%). Eight studies (272 infants) reported on failure rates for PDA closure in a subgroup of the above studies comparing oral ibuprofen with indomethacin (oral or iv). There was no significant difference between the groups (typical RR 0.96, 95% CI 0.73 to 1.27; typical RD -0.01, 95% CI -0.12 to 0.09). The risk of NEC was reduced with oral ibuprofen compared with indomethacin (oral or iv) (seven studies, 249 infants; typical RR 0.41, 95% CI 0.23 to 0.73; typical RD -0.13, 95% CI -0.22 to -0.05; NNTB 8, 95% CI 5 to 20; I2 = 0% for both RR and RD). There was a decreased risk of failure to close a PDA with oral ibuprofen compared with iv ibuprofen (four studies, 304 infants; typical RR 0.41, 95% CI 0.27 to 0.64; typical RD -0.21, 95% CI -0.31 to -0.12; NNTB 5, 95% CI 3 to 8). Transient renal insufficiency was less common in infants who received ibuprofen compared with indomethacin. High dose versus standard dose of iv ibuprofen, early versus expectant administration of iv ibuprofen, echocardiographically guided iv ibuprofen treatment vs. standard iv ibuprofen treatment and continuous infusion of ibuprofen vs. intermittent boluses of ibuprofen and long-term follow-up were studied in too few trials to draw any conclusions. Authors' conclusions Ibuprofen is as effective as indomethacin in closing a PDA and currently appears to be the drug of choice. Ibuprofen reduces the risk of NEC and transient renal insufficiency. Oro-gastric administration of ibuprofen appears as effective as iv administration. To make further recommendations, studies are needed to assess the effectiveness of high-dose versus standard-dose ibuprofen, early versus expectant administration of ibuprofen, echocardiographically guided versus standard iv ibuprofen, and continuous infusion versus intermittent boluses of ibuprofen. Studies are lacking evaluating the effect of ibuprofen on longer-term outcomes in infants with PDA.

The Influence of Physeal Status on Rate of Reoperation After Arthroscopic Screw Fixation for Symptomatic Osteochondritis Dissecans of the Knee

To determine if physeal status or other preoperative or intraoperative variables influence the failure rate after arthroscopic reduction and internal fixation of osteochondritis dissecans (OCD) lesions in the knee. Consecutive patients undergoing screw fixation of osteochondral fragments from OCD by a single surgeon from 2005 to 2015 with a minimum 2-year follow-up were included. Demographic, preoperative imaging, and intraoperative data were analyzed to determine risk factors associated with failure, which was defined as the need for a revision reoperation or arthroplasty after initial OCD fixation. A total of 45 knees met the inclusion criteria, including 26 skeletally mature patients and 19 patients with incompletely closed physes on preoperative imaging. The mean ages of the skeletally mature and immature groups were 18.3 ± 2.5 years and 14.9 ± 2.2 years, respectively (P < .001), and the mean body mass index values were 24.3 ± 3.6 and 23.2 ± 4.0, respectively (P= .432). We excluded 10 patients from the survivorship analysis because they had less than 2 years' follow-up. No statistically significant difference in failure rates was found between skeletally mature and immature individuals (30% and 40%, respectively; P= .721). The only factor significantly associated with fixation failure was undergoing a prior surgical procedure to address the OCD lesion (P= .038). Kaplan-Meier analysis showed rates of overall survivorship from revision reoperations of 88.6% at 1 year and 68.8% at 5 years. Outcomes after internal fixation of OCD fragments are guarded, with a fragment survival rate of 65.7% at a mean of 4.1 years' follow-up. No difference in fragment survival was noted in skeletally mature versus immature patients. The only independent risk factor identified for fixation failure was the number of previous operations. LEVELOF EVIDENCE: Level IV, case series with subgroup analysis.

A Systematic Review of Survival Rates of Osseointegrated Implants in Fully and Partially Edentulous Patients Following Immediate Loading.

Background: The aim of this systematic review was to evaluate the survival rates of immediately loaded implants after at least five years. Besides implant failure, the amount of marginal bone loss around implants and the complication type were assessed. Methods: The electronic search was undertaken on Medline, Scopus, and Cochrane Central Register of Controlled Trials using key terms such as: “immediate loading”, “immediate function”, “immediate restoration”, “immediate temporization”, “dental implants”, “fully edentulous patients”, “partially edentulous patients”. The search terms were combined using the Boolean operators AND, OR. The last electronic search was performed on 15 February 2018. Two authors independently screened the studies, extracted the data, and assessed the risk-of bias. The main outcomes recorded for each study were: implant and prosthesis success and survival, marginal bone level change, incidence and type of complications. Kaplan–Meier analysis was used to estimate cumulative survival rates. Results: Thirty-four prospective studies with at least five-year follow-up, published between 2007 and 2017 were included. A total of 5349 immediately loaded implants in 1738 patients were analyzed. The mean follow-up was 72.4 months (median 60 months, 95% confidence intervals (CI): 64.53, 80.25 months, range 60 to 147 months). The mean weighted implant survival was 97.4% (median 98.15%, 95% CI: 96.29%, 98.54%, range 83.80% to 100%). Cumulative survival rate of implants placed in the mandible was significantly higher than for the maxilla (p < 0.01). No significant difference in failure rate was found among the types of prosthesis employed (p = 0.27). The mean peri-implant bone level change at the end of the follow-up in each study ranged from 0.3 to 1.7 mm. Conclusion: Immediate loading of implants appears to have long-term predictability and success rate under well-defined circumstances.

Primary baerveldt versus trabeculectomy study after 5years of follow-up.

PurposeAlthough the Baerveldt glaucoma implant (BGI) initially was reserved for refractory glaucoma, its role in the surgical management of glaucoma has shifted towards a primary treatment choice. We performed a randomized prospective study to compare BGI surgery and trabeculectomy (TE) in patients without previous ocular surgery.MethodsWe included 119 glaucoma patients without previous ocular surgery. One eye of each subject was randomized to either a BGI or TE. Follow‐up visits were at 1 day, 2 weeks, 6 weeks, 3 months, 6 months and 1, 2, 3, 4 and 5 years postoperatively. Primary outcomes were intraocular pressure (IOP) and failure rate. Secondary outcomes were medication, anterior chamber laser flare value and complications.ResultsAfter 5 years, an IOP of 12.7 ± 3.9 mmHg (mean ± SD) was achieved in the TE group and 12.9 ± 3.9 mmHg in the BGI group. We found no statistically significant difference in failure rate between the groups (p = 0.72). More BGI patients needed additional medication to control their IOP (85%; 1.9 ± 1.2 types of glaucoma medication) compared to the TE patients (57%; 0.5 ± 0.9 types of glaucoma medication). Diplopia was significantly more present in the BGI group than in the TE group (27% versus 4%; p < 0.001). The self‐limiting complication rate was similar in both groups.ConclusionsOur study demonstrates that, in the long term, the final IOP and failure rate are similar after TE and BGI surgery. However, the need for additional medication after BGI surgery is higher than after TE. Also, the increased risk of developing diplopia after BGI surgery must be taken into consideration.

Allograft Augmentation of Hamstring Anterior Cruciate Ligament Autografts Is Associated With Increased Graft Failure in Children and Adolescents

Background: Anterior cruciate ligament (ACL) reconstruction in adolescents is commonly performed with hamstring tendon autografts. Small graft diameter is one risk factor for graft failure and options to upsize the autologous hamstring graft include allograft augmentation and tripling one or both of the hamstring tendons. Purpose: To evaluate the association of upsized hamstring graft constructs and graft rupture after ACL reconstruction. Study Design: Cohort study; Level of evidence, 3. Methods: A retrospective review was performed of patients 19 years of age and younger who underwent hamstring autograft ACL reconstruction with or without soft tissue allograft augmentation from 2012 to 2016. All patients were skeletally mature or had less than 2 years of growth remaining. Graft constructs included 4-strand doubled semitendinosus and gracilis autograft (4-STG), 5-strand tripled semitendinosus and doubled gracilis autograft (5-STG), and 6-strand doubled gracilis and semitendinosus autograft augmented with a soft tissue allograft (6-STGAllo). The primary outcome measure was graft rupture. Results: A total of 354 patients with a mean age of 15.3 years (range, 10-19 years) were included. Graft constructs included 4-STG (198 knees), 5-STG (91 knees), and 6-STGAllo (65 knees). The average diameter of the graft constructs was 8.3 mm for 4-STG, 8.9 mm for 5-STG, and 9.2 mm for 6-STGAllo (P < .001). The mean follow-up was 26 months (range, 6-56 months). There were 50 (14%) graft ruptures and 24 (7%) contralateral ACL tears. The graft failure rates were 14% for 4-STG, 12% for 5-STG, and 20% for 6-STGAllo (P = .51). The average time to graft failure was 16 months (range, 2-40 months). After adjusting for age and graft size, patients who had allograft-augmented grafts (6-STGAllo) had 2.6 (95% CI, 1.02, 6.50) times the odds of graft rupture compared with 4-STG. There was no significant difference in failure rate between patients who had 5-STG grafts compared with 4-STG (OR, 1.2; 95% CI, 0.5, 2.7). Conclusion: ACL reconstruction with hamstring tendon autografts augmented with allografts has a significantly increased risk of graft rupture compared with comparably sized hamstring tendon autografts. In situations where the surgeon harvests an inadequately sized 4-strand autograft, we recommend obtaining a larger graft diameter by tripling the semitendinosus rather than augmenting with an allograft.

Prior endoscopic third ventriculostomy does not increase ventriculoperitoneal shunt failure rate.

To determine whether prior endoscopic third ventriculostomy (ETV) influences the failure rate of subsequently placed ventriculoperitoneal (VP) shunts. Our institution's operative database and patient records were reviewed retrospectively to identify all paediatric patients who had undergone a first VP shunt or ETV at our institution between January 2012 and December 2015. Data was analysed using the Microsoft Excel, GraphPad Prism v7 and SPSS statistics. The literature on this topic to date was also reviewed. Eighty-six children were included in the study: 61 patients had a primary VP shunt inserted during the study period and 25 had a VP shunt inserted following failed ETV. There was no significant difference in the underlying aetiology or age of the patients in each group. In the primary VP shunt group, 47.5% (29 patients) required shunt removal at an average of 274days post-insertion (range 7days to 3.4years). The 1-year revision rate was 34.4%. In the shunt post-ETV group, 48% (12 patients) required shunt removal at an average of 207days post-insertion (range 2days to 2.7years). The 1-year revision rate was 36%. The most common reason for revision in both groups was blockage. We found no significant difference in failure rate or pattern between primarily inserted VP shunts and those inserted following an endoscopic third ventriculostomy. On the basis of this study and the small number of previously reported studies, we would advocate a trial of ETV where feasible to allow a chance at shunt independence.

Converting clinical insights and experiences into valid and rigorous research: a clinician's guide

Patients included in randomized controlled trials (RCT) are poorly representative of the general population. We compared outcomes of patients excluded from the PIRATE trial, a point-of-care RCT evaluating antibiotic durations for Gram-negative bacteraemia, with those of enrolled patients.A prospective observational cohort study, ‘EPCO’ (Excluded Patients' Clinical Outcomes) included patients excluded from the PIRATE trial. As in PIRATE, whose patients were randomized to 7-day, 14-day, or C-reactive-protein (CRP)-guided antibiotic durations, EPCO's primary outcome was occurrence of clinical success at 30 days. We also compared baseline characteristics, outcome rates and treatment-effect estimates.In all, 405 patients were included in EPCO and compared with the 503 PIRATE patients. Reasons for exclusion were mainly medical (317/405; 78%), the most frequent being complicated infection. Excluded patients had more co-morbidities (Charlson median 3 versus 1, p < 0.001). Bacteraemia was more often health-care-associated (26% versus 9%, p < 0.001). The 30-day success rate was significantly lower among EPCO patients (299/396; 76% versus 469/493; 95%, p < 0.001), but the success rate was not significantly different for those excluded for non-medical reasons (68/75; 91%, p 0.09). There was no significant difference in failure rates of EPCO patients according to their treatment duration (difference 7 days versus 14 days: p 0.75; 7 days versus CRP-correspondent: p 1.00; 14 days versus CRP-correspondent: p 1.00).Although point-of-care-randomized trials are more inclusive and representative than traditional RCTs, they are still likely to select patients with lower failure risk. Shorter antibiotic durations were not associated with failure in either included or excluded patients, supporting the generalizability of the PIRATE trial's findings.

Benefits and Adverse Events Associated With Extended Antibiotic Use in Total Knee Arthroplasty Periprosthetic Joint Infection.

Total knee arthroplasty (TKA) periprosthetic joint infection (PJI) can be managed with debridement, antibiotic therapy, and implant retention (DAIR). Oral antibiotics can be used after DAIR for an extended time period to improve outcomes. The objective of this study was to compare DAIR failure rates and adverse events between an initial course of intravenous antibiotic therapy and the addition of extended treatment with oral antibiotics. A multicenter observational study of patients diagnosed with a TKA PJI who underwent DAIR was performed. The primary outcome of interest was the failure rate derived from the survival time between the DAIR procedure and future treatment failure. One hundred eight patients met inclusion criteria; 47% (n = 51) received an extended course of oral antibiotics. These patients had a statistically significant lower failure rate compared to those who received only intravenous antibiotics (hazard ratio, 2.47; P = .009). Multivariable analysis demonstrated that extended antibiotics independently predicted treatment success, controlling for other variables. There was no significant difference in failure rates between an extended course of oral antibiotics less or more than 12 months (P = .23). No significant difference in the rates of adverse events was observed between patients who received an initial course of antibiotics alone and those who received a combination of initial and extended antibiotic therapy (P = .59). Extending therapy with oral antibiotics had superior infection-free survival for TKA PJI managed with DAIR. There was no increase in adverse events, demonstrating safety. After 1 year, there appears to be no significant benefit associated with continued antibiotic therapy.

Hybrid graft vs autograft in anterior cruciate ligament reconstruction: a meta-analysis.

PurposeWe conducted this meta-analysis to evaluate the efficacy of hybrid grafts in anterior cruciate ligament reconstruction (ACLR).MethodsWe performed an electronic search of the Cochrane Library, PubMed, Embase, and ScienceDirect from the inception of these databases to February 2018, based on the terms “anterior cruciate ligament or ACL reconstruction”, “autograft”, “hybrid”, and “augment”. Relevant journals and conference proceedings were searched manually. Quality assessment, data extraction, and calculation of data from the included studies were conducted independently by two reviewers using RevMan 5.1.ResultsOne randomized controlled trial and eight nonrandomized controlled trials met inclusion criteria. Larger graft diameters were found in the hybrid-graft group (mean difference −1.47, P=0.0001). There was no significant difference in failure rate (OR 2.13, P=0.21), retearing (OR 2.23, P=0.12), revision of ACLR (OR 1.05, P=0.87) or reoperation (OR 1.27, P=0.35). Subgroup analysis showed that hybrid-graft patients with meniscus injury suffered more revision (OR 4.10, P=0.02) and reoperation (OR 5.74, P=0.001). Both autografts and hybrid grafts performed similarly in most knee-score systems. However, autograft patients had better KT-1000 (mean difference 0.24, P=0.05) and quality-of-life results on the Knee Injury and Osteoarthritis Outcome Score measure (mean difference 7.23, P=0.05).ConclusionThis meta-analysis of the current literature indicates similar performance of hybrid or autologous grafts in ACLR, though hybrid grafts had larger diameters than autografts. Other potential factors to influence failure, revision, or postoperative knee function, such as irradiation, age at reconstruction, meniscus injury/treatment, and hybrid-graft remodeling, should be investigated further.

DOES THE USE OF A “HYBRID” GRAFT ALTER GRAFT FAILURE RATES OR OUTCOMES IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION? A SYSTEMATIC REVIEW AND META-ANALYSIS

Background The use of hamstring autografts less than 8.0mmin size to reconstruct anterior cruciate ligament (ACL) injuries is associated with a higher risk of graft failure. A hybrid graft consisting of hamstring autograft tendons supplemented by allograft tendon to create a more robust graft has been proposed as an alternative treatment option in patients with small hamstring graft size. Multiple studies have shown inconsistent results for ACL reconstructions with hybrid grafts. This meta-analysis was designed to examine the rates of graft failure and clinical outcome measures for hybrid grafts in primary ACL reconstructions. Methods A search was performed of PubMed, MEDLINE and Google Scholar using the terms “Anterior Cruciate Ligament” OR “ACL” combined with “reconstruction” and “hybrid.” Two authors reviewed the papers, and outcomes were subdivided into autograft and hybrid graft. Chi Square with Yates Correction was used to determine the correlation between failure and type of graft for all patients, as well as for the subanalysis done for patients less than 18 years old and patients greater than 18 years old. Chi Square with Yates Correction and unpaired t-test were used to compare the demographic characteristics of the two groups. Unpaired t-test was used to evaluate for differences in subjective outcome scores. Results A total of 9 studies met the inclusion criteria. Only one study included a comparison of hybrid grafts with autografts and allografts, and as such, the allograft data was excluded from the analysis. Overall a total of 506 patients were treated with autografts with an average age of 26.7 +/- 10.8 years; and a total of 453 patients were treated with hybrid grafts with an average age of 28.33 +/-10.4 years. All patients had minimum follow up of 2 years with average follow up of 38.2 months. There was no significant difference in sex between the two groups (p = 0.07). There were significantly more females in the hybrid group compared to the autograft group (48% versus 42%, respectively p = 0.02). There was no significant difference in failure rates for the autograft or hybrid graft subgroups (p = 0.92). International Knee Documentation (IKDC) scores and Lysholm scores were significantly higher in the autograft group than the hybrid graft group (p = 0.02 and p &lt; 0.01, respectively). There was no significant difference in Tegner Activity scores (p =0.68). On further subgroup analysis, there was no difference in failure rates for autografts vs hybrid grafts with subgroup analysis for both patients under 18 years of age and patients over 18 years of age (p = 0.78 and p = 0.24, respectively). Conclusions Supplementation of hamstring autograft with allograft tissue to form a “hybrid graft” did not alter the graft failure rate. But, the use of hybrid graft was associated with worse subjective outcome scores as measured by IKDC and Lysholm scores. Level of Evidence Level IV (A meta-analysis of Level II, III, and IV studies)

Five-Strand Hamstring Autografts for Anterior Cruciate Ligament Reconstruction: A Systematic Review.

Background:Recent studies have described surgical techniques to increase the hamstring graft diameter for anterior cruciate ligament reconstruction (ACLR), particularly for 5-strand hamstring (5HS) autografts.Purpose:To review the literature examining the biomechanical and clinical outcomes of 5HS autografts for ACLR.Study Design:Systematic review; Level of evidence, 3.Methods:A systematic review using PRISMA (Preferred Reporting Items for Systematic Meta-Analyses) guidelines was performed by searching PubMed, Embase, and the Cochrane Library for studies reporting the biomechanical and clinical outcomes of 5HS autografts. All English-language literature published from 2012 to 2018 that reported the biomechanical properties of 5HS grafts and/or clinical outcomes after ACLR with 5HS autografts with a minimum 1-year follow-up was reviewed by 2 independent reviewers. Graft diameter, stiffness, displacement, strength, failure rates, anteroposterior knee laxity, and patient-reported outcome scores were collected. The study methodology was evaluated using the modified Coleman Methodology Score.Results:Two biomechanical and 3 clinical studies (1 with level 2 evidence, 2 with level 3 evidence) were included. The biomechanical studies compared the results of fourteen 4-strand hamstring (4HS) and fourteen 5HS graft specimens for ACLR (ovine grafts, n = 12; cadaveric grafts, n = 16) and found no significant differences in ultimate load, stiffness, displacement, and stress relaxation (P > .05), likely attributed to insufficient incorporation of the fifth strand. The mean 5HS cadaveric graft diameter (8.2 mm) was significantly greater than that of 4HS grafts (6.8 mm) (P = .002), whereas the mean ovine graft diameters were not significantly different (4HS, 5.2 mm; 5HS, 5.3 mm) (P > .05). Two clinical studies compared the outcomes after ACLR of 53 patients with a 4HS autograft versus 62 patients with a 5HS autograft, while 1 clinical study reported the outcomes of 25 patients after ACLR with a 5HS autograft (mean age, 28.7 years; mean follow-up, 24.8 months). The overall mean diameter for 4HS and 5HS autografts was 8.4 and 9.1 mm, respectively. There was no significant difference in failure rates between 4HS and 5HS autografts (P = .82). None of the comparative studies reported significant differences in any clinical outcomes (P > .05 for all).Conclusion:The available literature on traditional 4HS and 5HS autografts for ACLR is limited. Of the available data, clinical and biomechanical studies suggest no difference in outcomes after ACLR with either graft construct. Additional research is needed to determine whether creating a 5HS graft is beneficial.

1036. Whole Genome Sequencing Analysis of a Large Cohort of Staphylococcus epidermidis Blood Culture Positive Isolates From a Multicenter Clinical Trial

Background Staphylococcus epidermidis is a leading cause of healthcare-associated bacteremia, but the clinical course of S. epidermidis isolated from blood cultures ranges from contamination to serious deep seated infections. We tested the hypothesis that the genetic characteristics of S. epidermidis isolated from blood cultures are significantly associated with disease severity using whole genome sequencing (WGS).MethodsWe performed WGS of 163 S. epidermidis isolates from a large prospective multicenter, randomized control trial that assessed the safety and efficacy of algorithm-based treatment of patients with staphylococcal bacteremia (ClinicalTrials.gov #NCT01191840). Patient’s infection types were divided into simple (including possible contamination), uncomplicated and complicated bacteremia. Failure was defined as persistent signs and symptoms of infection at 72 hours, persistent bacteremia at 7 days, relapse, complications or overall mortality within 28 days of therapy. WGS was performed using Illumina Miseq, followed by in silico multi-locus sequence type identification and phylogenomic analysis using kSNP.ResultsOf the 163 isolates analyzed, 39 sequence types (STs) were identified with ST2 and ST5 isolates being most frequently identified (21% and 20%, respectively). ST2 and ST5 isolates were significantly more likely associated with uncomplicated and complicated infections rather than simple bacteremia (P = 0.01 by χ2 test). By multivariate regression analysis, having an ST2 or ST5 S. epidermidis bacteremia was an independent predictor of a complicated infection (odds ratio 4.28, 95% CI 1.36–13.42). Using WGS based branching points rather than sequence typing allowed for additional strengthening of the association of S. epidermidis genetic clustering and clinical infection types (figure). Although there was no significant difference in failure rates among patients infected with different STs, ST2/ST5 strains were significantly more likely to cause relapsing infections (85.7%, P = 0.02).ConclusionWGS could offer a prognostic tool in the management of S. epidermidis bacteremia. ST2 and ST5 strains may help predict a complicated bacteremia course which would warrant appropriate antimicrobial therapy. Disclosures T. L. Holland, Basilea: Consultant, Consulting fee. Motif Bio: Consultant and Scientific Advisor, Consulting fee. Theravance: Consultant, Speaker honorarium. Genentech: Consultant, Consulting fee. V. G. Fowler Jr., Debiopharm: Consultant, Consulting fee. Durata: Consultant, Consulting fee. Merck: Consultant and Scientific Advisor, Consulting fee. Cerexa/Actavis/Allergan: Grant Investigator, Grant recipient. Pfizer: Consultant and Grant Investigator, Consulting fee and Grant recipient. Advanced Liquid Logics: Grant Investigator, Grant recipient. NIH: Grant Investigator, Grant recipient. MedImmune: Consultant and Grant Investigator, Consulting fee and Grant recipient. Basilea: Consultant and Grant Investigator, Consulting fee and Grant recipient. Karius: Grant Investigator, Grant recipient. Contrafect: Consultant and Grant Investigator, Consulting fee and Grant recipient. Regeneron: Grant Investigator, Grant recipient. Genentech: Consultant and Grant Investigator, Consulting fee and Grant recipient. Affinergy: Consultant and Grant Investigator, Consulting fee and Grant recipient. Locus: Grant Investigator, Grant recipient. Medical Surface, Inc.: Grant Investigator, Grant recipient. Theravance: Consultant, Consulting fee and Speaker honorarium. Green Cross: Consultant, Speaker honorarium. Grifols: Consultant, Consulting fee. xBiotech: Consultant, Consulting fee. Achaogen: Consultant, Consulting fee. Medicines Co: Consultant, Consulting fee. Novartis: Consultant, Consulting fee. Novadigm: Consultant, Consulting fee. Bayer: Consultant, Consulting fee. Cubist: Consultant, Consulting fee. Debiopharm: Consultant, Consulting fee. Durata: Consultant, Consulting fee. I. Raad, The University of Texas MD Anderson Cancer Center: Shareholder, Licensing agreement or royalty. The Unversity of Texas MD Anderson Cancer Center: Shareholder, Dr. Raad is a co-inventor of the Nitroglycerin-Citrate-Ethanol catheter lock solution technology which is owned by the University of Texas MD Anderson Cancer Center (UTMDACC) and has been licensed to Novel Anti-Infective Technologies LLC, in which UTMDACC and Licensing agreement or royalty.

Ibuprofen for the treatment of patent ductus arteriosus in preterm or low birth weight (or both) infants.

Ibuprofen for the treatment of patent ductus arteriosus in preterm or low birth weight (or both) infants.

Primary Baerveldt versus trabeculectomy study after one-year follow-up.

To compare a Baerveldt implant and trabeculectomy with respect to intraocular pressure (IOP) and failure rate at 1year of follow-up. Secondary outcomes are pharmacological therapy and complications at 1year of follow-up. This was a randomized, comparative study. A total of 119 glaucoma patients without previous ocular surgery were included at the Rotterdam Eye Hospital, the Netherlands. One eye of each subject was randomized to either a Baerveldt glaucoma drainage device (BGI) or trabeculectomy (TE). Follow-up visits were conducted at 1day, 2weeks, 6weeks, 3months, 6months and 1year after surgery. After one year, the final IOP was equivalent for both treatment groups: 14±4mmHg (mean ± SD) for the Baerveldt group versus 13±4mmHg for the trabeculectomy group. Statistically, we found no significant difference in failure rate between the two groups. However, the Baerveldt group needed significantly more medication to decrease IOP. Overall, self-limiting complication rate was similar in both groups. Diplopia, a serious complication, was significantly more present in the BGI group. One year after surgery, TE shows better results than the BGI. The final IOP, IOP reduction and failure rate are similar, but the need for additional IOP lowering medication in the BGI group is higher as well as the complication rate. The increased risk of developing diplopia after placement of a BGI must be taken into consideration.

Internal Fixation of Unstable Osteochondritis Dissecans: Do Open Growth Plates Improve Healing Rate?

Background: Osteochondritis dissecans (OCD) is a disorder of unknown origin that can affect knees in skeletally mature and immature patients. Surgical management is an important cornerstone of treatment for unstable OCD lesions. Purpose: To determine the (1) healing rate after internal fixation of unstable OCD between skeletally immature and mature knees, (2) risk factors for failure, and (3) patient-reported outcomes among healed patients. Study Design: Cohort study; Level of evidence, 3. Methods: A multicenter retrospective cohort study was conducted with patients who underwent internal fixation of unstable knee OCD lesions from 2000 to 2015. Skeletal immaturity was defined as open or partially open physes. Healing was assessed through clinical findings and imaging. Definitive reoperation for the same OCD lesion was classified as failure. Results: Among 87 patients included, 66 (76%) had healed lesions at ≥2 years postoperatively, while 21 (24%) failed. Skeletal maturity made no significant difference in failure rate (risk ratio, 0.68; 95% CI, 0.29-1.72; P = .40). For skeletally immature patients, lateral versus medial condylar location conferred an increased hazard of 18.2 (95% CI, 1.76-188.07; P < .01). Multivariate analysis factoring in skeletal maturity showed that lateral condylar location was an independent risk factor for failure (hazard ratio, 4.25; 95% CI, 1.47-19.85; P < .01). Mean patient-reported outcome scores (International Knee Documentation Committee [IKDC] and Knee injury and Osteoarthritis Outcome Score [KOOS]) increased significantly after surgery, except the KOOS symptoms score for the skeletally mature group. Final scores (mean ± SD) were as follows at a mean follow-up of 60 months (range, 24-166): IKDC, 83.5 ± 20.2; KOOS pain, 89.7 ± 14.1; KOOS symptoms, 87.4 ± 18.4; KOOS activities of daily living, 93.9 ± 12.7; KOOS sports, 80.7 ± 25.9; KOOS quality of life, 78.9 ± 23.1. Conclusion: Skeletally immature and mature patients heal at comparable rates after internal fixation of OCD lesions, resulting in functional and subjective improvement. Lateral femoral condylar lesion location is an independent risk factor for failure.