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Primary open anterior shoulder stabilization: a long-term, retrospective cohort study on the impact of subscapularis muscle alterations on recurrence.
BACKGROUND: Post-traumatic anterior shoulder instability patients may present histopathologic lesions within the subscapularis muscle compatible with a scarring process associated with disuse atrophy. We hypothesized that such lesions identified on intraoperative biopsy at the time of primary anterior shoulder stabilization would predict a higher risk of postoperative instability recurrence. METHODS: Of 52 eligible patients (52 shoulders) who had undergone subscapularis muscle biopsy during primary anterior open labral repair and capsulorrhaphy, 35 (mean age at surgery, 27.2 years; male sex, 71.4%) were retrospectively evaluated (mean follow-up, 12.9 years; range, 10.9-14.5 years). Primary outcome was shoulder instability recurrence. Secondary outcomes included shoulder range of motion, functional scores, and radiological analysis of glenohumeral joint degenerative changes. RESULTS: Overall five patients (14.3%) presented shoulder instability recurrence. Twelve patients with histopathologic lesions had significantly more instability recurrence than 23 without histopathologic changes (33.3% vs. 4.3%; risk difference, 29% [95% CI 1; 57]; p = 0.038). Patients without histopathologic changes had significantly reduced external rotation with arm at side (ER1; -11.9°; p = 0.001) and with shoulder abducted to 90° (ER2; -14.9°; p = 0.001) on the operated side when compared to the contralateral side. Patients with histopathologic lesions had only ER2 significantly reduced (-8.9°; p = 0.031). There was no substantial difference regarding functional and quantitative radiological scores between both patients' groups. CONCLUSIONS: Histopathologic changes within the subscapularis muscle at the time of primary open labral repair and capsulorrhaphy were associated with an increased risk of shoulder instability recurrence. Further investigations are needed to assess the impact of dedicated postoperative rehabilitation programs for patients presenting these lesions. Their recognition on preoperative magnetic resonance imaging should also be investigated; non-anatomical repairs could be an option in these cases.
Influence of obesity on femoral osteolysis five and ten years following total hip arthroplasty.
BACKGROUND: The most important long-term complication following total hip arthroplasty is periprosthetic femoral osteolysis. A sizeable proportion of patients who undergo arthroplasty are obese. While patient activity, implant type, and quality of fixation are known risk factors for osteolysis, the literature concerning obesity is sparse and controversial. Our primary objective was to evaluate the influence of obesity on the risk of osteolysis five and ten years after primary total hip arthroplasty with a cemented stem. Secondary objectives were to evaluate clinical outcome and patient satisfaction. METHODS: We conducted a prospective cohort study of patients undergoing hip arthroplasty with a third-generation stem-cementing technique from 1996 to 2003. All patients were seen at five or ten years postoperatively. Radiographs and information regarding body-mass index (<25 kg/m(2) = normal weight, 25 to 29.9 kg/m(2) = overweight, and > or = 30 kg/m(2) = obese) and activity were obtained. Activity was assessed with use of the University of California at Los Angeles (UCLA) activity scale. Osteolysis was assessed radiographically. Clinical outcome measurements included the Harris hip and Merle d'Aubigné and Postel scores. RESULTS: Our study included 503 arthroplasties in 433 patients; the results of 241 (47.9%) of the arthroplasties were evaluated at five years and the results of 262 (52.1%), at ten years. Osteolysis was identified around forty-four stems, with twenty-four (13.3%) in 181 hips of normal-weight patients, eleven (5.4%) in 205 hips of overweight patients, and nine (7.7%) in 117 hips of obese patients. Normal-weight patients had the highest activity level (mean UCLA activity scale score [and standard deviation], 5.5 + or - 2.0 points), and obese patients had the lowest (mean UCLA activity scale score, 5.0 + or - 1.7 points). When adjusted for activity, cementing quality, and patient age and sex, the risk of osteolysis in obese patients was not increased as compared with that for overweight patients (adjusted odds ratio, 1.4; 95% confidence interval, 0.6 to 3.7), whereas the risk of femoral osteolysis in normal-weight patients was found to be significantly higher than that in overweight patients (adjusted odds ratio, 2.6; 95% confidence interval, 1.2 to 5.7). Clinical outcomes were similar among the groups. CONCLUSIONS: We found no increased risk of osteolysis around a cemented femoral stem in obese patients five and ten years after primary total hip arthroplasty. The highest prevalence of osteolysis was observed in normal-weight patients. LEVEL OF EVIDENCE: Prognostic Level I. See Instructions to Authors for a complete description of levels of evidence.
Clinical and radiographic predictors of acute compartment syndrome in the treatment of tibial plateau fractures: a retrospective cohort study.
BACKGROUND: The aim of the study was to evaluate the relation between demographic, injury-related, clinical and radiological factors of patients with tibial plateau fractures and the development of acute compartment syndrome. METHODS: All consecutive adult patients with intra-articular tibial plateau fractures admitted in our urban academic medical centre between January 2005 and December 2009 were included in this retrospective cohort study. The main outcome measurement was the development of acute compartment syndrome. RESULTS: The charts of 265 patients (mean age 48.6 years) sustaining 269 intra-articular tibial plateau fractures were retrospectively reviewed. Acute compartment syndrome occurred in 28 fractures (10.4%). Four patients presented bilateral tibial plateau fractures; of them, 2 had unilateral, but none had bilateral acute compartment syndrome. Non-contiguous tibia fracture or knee dislocation and higher AO/OTA classification (type 41-C) were statistically significantly associated with the development of acute compartment syndrome in multivariable regression analysis, while younger age (<45 years), male sex, higher Schatzker grade (IV-V-VI), higher tibial widening ratio (≥1.05) and higher femoral displacement ratio (≥0.08) were significantly associated in the analysis adjusted for age and sex. CONCLUSIONS: Two parameters related to the occurrence of ACS in tibial plateau fractures were highlighted in this study: the presence of a non-contiguous tibia fracture or knee dislocation, and higher AO/OTA classification. They may be especially useful when clinical findings are difficult to assess (doubtful clinical signs, obtunded, sedated or intubated patients), and should rise the suspicion level of the treating surgeon. In these cases, regular clinical examinations and/or intra-compartmental pressure measurements should be performed before and after surgery, even if acute compartment syndrome seemed unlikely during initial assessment. However, larger studies are mandatory to confirm and refine both factors in predicting the occurrence of acute compartment syndrome.
Outcomes of obese and nonobese patients undergoing revision total hip arthroplasty.
OBJECTIVE: To evaluate the effect of obesity on the incidence of adverse events (surgical site infection, dislocation, re-revision, or > or =1 adverse event), functional outcome, residual pain, and patient satisfaction after revision total hip arthroplasty (THA). METHODS: We conducted a university hospital-based prospective cohort study including 52 obese and 152 nonobese patients with revision THA performed between 1996 and 2006. We used incidence rates, rate ratios, and hazard ratios (HRs) to compare the incidence of events in obese and nonobese patients and in 4 body mass index (BMI) categories (<25, 25-29.9, 30-34.9, > or =35). Functional outcome and pain were measured 5 years postoperative using the Harris Hip Score. RESULTS: The incidence rate for > or =1 complication increased with rising BMI (1.8, 3.4, 10.3, and 17.9 cases/100 person-years). The increase was small between normal and overweight patients (adjusted HR 1.5, 95% confidence interval [95% CI] 0.5, 4.7), significantly greater with BMI 30-34.9 (adjusted HR 4.5, 95% CI 1.4, 14.0), and most evident with BMI > or =35 (adjusted HR 10.9, 95% CI 2.9, 41.1). The adjusted HR for surgical site infection (obese versus nonobese) was 4.1 (95% CI 1.1, 15.0) and for dislocation 3.5 (95% CI 1.3, 9.3). Eighty patients had a followup visit at 5 years. Obese patients had moderately lower functional results and higher levels of residual pain, but patient satisfaction was almost similar. CONCLUSION: Revision THA is technically challenging, particularly in obese patients, probably due to more difficult anatomic conditions. We found an increased risk of adverse events, notably surgical site infection and dislocation in these patients.
Influence of preoperative patient education on the risk of dislocation after primary total hip arthroplasty.
OBJECTIVE: Dislocation is a well-known complication after total hip arthroplasty (THA), and is the second-highest cause of revision surgery. Our objective was to assess the effect of preoperative patient education on the occurrence of hip dislocation within 6 months after primary THA. METHODS: Between 1998 and 2007, we conducted a prospective cohort study at the Geneva University Hospital Department of Orthopaedic Surgery, including all primary THAs performed via an anterolateral transgluteal approach with the use of a 28-mm diameter head. The preoperative education session was introduced in June 2002 and included advice on muscle strengthening exercises and postoperative restrictions of range of motion as a means of preventing dislocation. The main outcome was the incidence of dislocation within 6 months of surgery. RESULTS: A total of 597 patients who underwent 656 THAs between June 2002 and June 2007 participated in the education session, whereas 1,641 patients who underwent 1,945 procedures did not. Forty-six dislocations occurred over the study period, 5 (0.8%) in participants and 41 (2.1%) in nonparticipants (absolute risk reduction 1.3%; 95% confidence interval [95% CI] 0.4, 2.3), with the time interval between surgery and dislocation being significantly shorter among participants (0.2 versus 1.2 months). Nonparticipants had a 2.8 times higher risk of dislocation than participants (unadjusted odds ratio [OR] 2.80; 95% CI 1.10, 7.13). Adjustment for age, sex, comorbidities, and prior surgery did not change the results (adjusted OR 2.79; 95% CI 1.09, 7.15). CONCLUSION: Our findings suggest that participation in a preoperative patient education session may reduce the risk of dislocation within 6 months after THA.
Differences in outcomes of obese women and men undergoing primary total hip arthroplasty.
OBJECTIVE: To evaluate the effect of obesity on the incidence of main complications (infection, dislocation, and revision), functional outcome, and patient satisfaction 5 years after primary total hip arthroplasty (THA), and to determine whether results differ between obese women and men. METHODS: We conducted a hospital-based prospective cohort study including patients who underwent primary THA (2,495 hips) between 1996 and 2005. We used rates and rate ratios to compare the incidence of main complications in obese and nonobese patients, and we stratified the data for sex. Functional outcome was measured using the Harris Hip Score and Western Ontario and McMaster Universities Osteoarthritis Index. RESULTS: The adjusted incidence rate ratio for infection (obese versus nonobese) was 4.4 (95% confidence interval [95% CI] 1.8, 10.8). Obesity substantially increased the infection rate in women (incidence rate ratio comparing obese with nonobese women 16.1; 95% CI 3.4, 75.7), whereas obesity appeared to have no effect in men (incidence rate ratio 1.0; 95% CI 0.2, 5.3). The adjusted incidence rate ratio for dislocation (obese versus nonobese) was 2.4 (95% CI 1.4, 4.2), with a higher rate increase in obese women. A total of 817 patients had a 5-year clinical followup visit. Functional outcome and satisfaction were slightly lower in obese women partly due to higher complication rates. No difference was seen in men. CONCLUSION: Primary THA is a successful intervention in obese patients, but physician and patient must be aware of increased complications, particularly in women.
Important patient characteristics differ prior to total knee arthroplasty and total hip arthroplasty between Switzerland and the United States.
BACKGROUND: Outcomes after total knee (TKA) and hip (THA) arthroplasty are often generalized internationally. Patient-dependent factors and preoperative symptom levels may differ across countries. We compared preoperative patient and clinical characteristics from two large cohorts, one in Switzerland, the other in the US. METHODS: Patient characteristics were collected prospectively on all elective primary TKAs and THAs performed at a large Swiss hospital and in a US national sample. Data included age, sex, education level, BMI, diagnosis, medical co-morbidities, PROMs (WOMAC pain/function), global health (SF-12). RESULTS: Six thousand six hundred eighty primary TKAs (US) and 823 TKAs (Swiss) were evaluated. US vs. Switzerland TKA patients were younger (mean age 67 vs. 72 years.), more obese (BMI ≥30 55% vs. 43%), had higher levels of education, more cardiac disease. Swiss patients had lower preoperative WOMAC pain scores (41 vs. 52) but pre-operative physical disability were comparable. 4,647 primary THAs (US) and 1,023 THAs (Swiss) were evaluated. US vs. Switzerland patients were younger (65 vs. 68 years.), more obese (BMI ≥30: 38% vs. 24%), had higher levels of education, more diabetes. Swiss patients had lower preoperative WOMAC pain scores (40 vs. 48 points). Physical disability was reported comparable, but Swiss patients indicated lower mental health scores. CONCLUSION: We found substantial differences between US and Swiss cohorts in pre-operative patient characteristics and pain levels, which has potentially important implications for cross-cultural comparison of TKA/THA outcomes. Reports from national registries lack detailed patient information while these data suggest the need for adequate risk adjustment of patient factors.
Clinical Outcomes and Development of Symptomatic Osteoarthritis 2 to 24 Years After Surgical Treatment of Tarsometatarsal Joint Complex Injuries.
BACKGROUND: Injuries to the tarsometatarsal (TMT) joint complex, or Lisfranc injuries, have been reported to result in osteoarthritis (OA) following surgical treatment. Good outcomes with respect to short and medium-term results have been reported. However, long-term results, specifically regarding clinical outcomes and the development of symptomatic OA, are limited. The objectives of this study were to assess clinical outcomes, the occurrence of symptomatic OA, and risk factors for OA at 2 to 24 years after a Lisfranc injury treated surgically with open reduction and internal fixation (ORIF) or with primary arthrodesis. METHODS: This was a retrospective study involving 61 patients treated surgically at our institution between 1988 and 2009 for an injury to the TMT joint complex. Patients underwent either ORIF with transarticular screws or primary arthrodesis when joint comminution at the TMT level was such that ORIF was not possible. Functional outcomes were assessed according to the American Orthopaedic Foot & Ankle Society (AOFAS) score, the Foot Function Index (FFI), and a visual analog scale (VAS) for pain. Global health was evaluated with the Short Form (SF)-12 Health Survey physical component summary (PCS). RESULTS: Sixty-one of the 128 patients were available for clinical evaluation, including the use of questionnaires, and radiographic assessment at a mean of 10.9 years postoperatively (range, 2.4 to 23.9 years). Mean scores were as follows: AOFAS score, 79.0; FFI, 16.9, and VAS for pain, 2.5. Radiographic evidence of OA was noted in 44 (72.1%) of the patients, and symptomatic OA, in 54.1%, the latter having worse outcomes. Risk factors for OA were nonanatomic reduction, fracture classification of Myerson type C, and a history of smoking. CONCLUSIONS: Two to 24 years following surgical treatment to restore and maintain joint anatomy for Lisfranc injuries, we found satisfactory clinical outcome scores and a large number of patients who had returned to their previous level of functioning and employment, with little need for secondary procedures. However, there was a substantial occurrence of posttraumatic OA, as evident on radiographs, albeit the occurrence of symptomatic OA was lower. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
Introduction of innovations in joint arthroplasty: Recommendations from the 'EFORT implant and patient safety initiative'.
With the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process. The EFORT Implant and Patient Safety Initiative WG1 'Introduction of Innovation', combined knowledge of orthopaedic surgeons, research institutes, orthopaedic device manufacturers, patient representatives and regulatory authorities to develop a comprehensive set of recommendations for the introduction of innovations in joint arthroplasty within the boundaries of MDR 2017/745. Recommendations have been developed to address key questions about pre-clinical and clinical requirements for the introduction of new implants and implant-related instrumentation with the participation of a steering group, invited by the EFORT Board in dialogue with representatives from European National Societies and Speciality Societies. Different degrees of novelty and innovation were described and agreed on in relation to when surgeons can start, using implants and implant-related instrumentation routinely. Before any clinical phase of a new implant, following the pre-market clinical investigation or the equivalent device PMCF pathway, it is a common understanding that all appropriate pre-clinical testing (regulatory mandatory and evident state of the art) - which has to be considered for a specific device - has been successfully completed. Once manufacturers receive the CE mark for a medical device, it can be used in patients routinely when a clinical investigation has been conducted to demonstrate the conformity of devices according to MDR Article 62 or full equivalence for the technical, biological and clinical characteristics has been demonstrated (MDR, Annex XIV, Part A, 3.) and a PMCF study has been initiated.
Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature.
PURPOSE: The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force of the EU Medical Device Regulation in May 2021. METHODS: We systematically reviewed the medical literature for a random selection of hip and knee implants to identify all peer-reviewed clinical investigations published within 10 years before and up to 20 years after regulatory approval. We report study characteristics, methodologies, outcomes, measures to prevent bias, and timing of clinical investigations of 30 current implants. The review process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. RESULTS: We identified 2912 publications and finally included 151 papers published between 1995 and 2021 (63 on hip stems, 34 on hip cups, and 54 on knee systems). We identified no clinical studies published before Conformité Européene (CE)-marking for any selected device, and no studies even up to 20 years after CE-marking in one-quarter of devices. There were very few randomized controlled trials, and registry-based studies generally had larger sample sizes and better methodology. CONCLUSION: The peer-reviewed literature alone is insufficient as a source of clinical investigations of these high-risk devices intended for life-long use. A more systematic, efficient, and faster way to evaluate safety and performance is necessary. Using a phased introduction approach, nesting comparative studies of observational and experimental design in existing registries, increasing the use of benefit measures, and accelerating surrogate outcomes research will help to minimize risks and maximize benefits.
Treatment of reverse oblique and transverse intertrochanteric fractures with use of an intramedullary nail or a 95° screw-plate: A prospective, randomized study
Background: Intertrochanteric fractures are composed of different anatomic patterns that vary in their degree of stability following open reduction and internal fixation. A particularly unstable group is classified as AO/OTA 31-A3, with the fracture pattern described as reverse oblique or transverse. The purpose of this study was to compare the results of intramedullary fixation with those of plate fixation for these intertrochanteric fractures in elderly patients. Methods: Thirty-nine elderly patients with AO/OTA 31-A3 intertrochanteric fractures of the femur were randomized into two treatment groups and were followed for a minimum of one year. The nineteen patients in Group I were treated with a 95° fixed-angle screw-plate (Dynamic Condylar Screw), and the twenty patients in Group II were treated with an intramedullary nail (Proximal Femoral Nail). The treatment groups were comparable with regard to all demographic and injury variables. Results: Patients treated with an intramedullary nail had shorter operative times, fewer blood transfusions, and shorter hospital stays compared with those treated with a 95° screw-plate. Implant failure and/or nonunion was noted in seven of the nineteen patients who had been treated with the 95° screw-plate. Only one of the twenty fractures that had been treated with an intramedullary nail did not heal. Conclusion: The results of our study support the use of an intramedullary nail rather than a 95° screw-plate for the fixation of reverse oblique and transverse intertrochanteric fractures in elderly patients.
Burns in Malawi.
OBJECTIVE: To describe burns seen at the largest hospital in Malawi. METHODS: In a prospective study conducted at Queen Elizabeth Central Hospital, Blantyre, Malawi, a series of twelve accidental burns was analysed over a four-week period. RESULTS: Hot water was the commonest source of burns (6 out of 12). Open-fire and petroleum lamp accidents were the commonest cause of burns among epileptic patients. Males were affected more than females (male:female ratio = 8:4). Most burns were superficial (11 out of 12). One patient had deep burns requiring grafting. All patients were treated with topical silver sulphadiazine and a combination antibiotic regime. Children aged six yr or under were a major subgroup at risk of suffering burns (7 out of 12) and only one patient was aged over 30 yr. Lack of anti-epileptic medication resulted in potentially avoidable burns in four epileptic patients. CONCLUSIONS: There is a need for cheap preventive health promotion measures as well as the provision of simple resources as most burns encountered can be managed effectively by simple measures.
Current management of fractures of distal radius and ulna.
Distal radial and ulnar fractures are very common and their morbidity is greatly underestimated. This article reviews the current management of these injuries and that of their associated complications.
Persistence in risk and effect of COVID-19 vaccination on long-term health consequences after SARS-CoV-2 infection.
The persisting risk of long-term health consequences of SARS-CoV-2 infection and the protection against such risk conferred by COVID-19 vaccination remains unclear. Here we conducted a retrospective territory-wide cohort study on 1,175,277 patients with SARS-CoV-2 infection stratified by their vaccination status and non-infected controls to evaluate the risk of clinical sequelae, cardiovascular and all-cause mortality using a territory-wide public healthcare database with population-based vaccination records in Hong Kong. A progressive reduction in risk of all-cause mortality was observed over one year between patients with SARS-CoV-2 infection and controls. Patients with complete vaccination or have received booster dose incurred a lower risk of health consequences including major cardiovascular diseases, and all-cause mortality than unvaccinated or patients with incomplete vaccination 30-90 days after infection. Completely vaccinated and patients with booster dose of vaccines did not incur significant higher risk of health consequences from 271 and 91 days of infection onwards, respectively, whilst un-vaccinated and incompletely vaccinated patients continued to incur a greater risk of clinical sequelae for up to a year following SARS-CoV-2 infection. This study provided real-world evidence supporting the effectiveness of COVID-19 vaccines in reducing the risk of long-term health consequences of SARS-CoV-2 infection and its persistence following infection.
Bell's palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study.
BACKGROUND: Bell's palsy is a rare adverse event reported in clinical trials of COVID-19 vaccines. However, to our knowledge no population-based study has assessed the association between the inactivated SARS-CoV-2 vaccines and Bell's palsy. The aim of this study was to evaluate the risk of Bell's palsy after BNT162b2 and CoronaVac vaccination. METHODS: In this case series and nested case-control study done in Hong Kong, we assessed the risk of Bell's palsy within 42 days following vaccination with BNT162b2 (Fosun-BioNTech [equivalent to Pfizer-BioNTech]) or CoronaVac (from Sinovac Biotech, Hong Kong) using data from voluntary surveillance reporting with the Hospital Authority, the COVID-19 Vaccine Adverse Event Online Reporting system for all health-care professionals, and the Hospital Authority's territory-wide electronic health records from the Clinical Data Analysis and Reporting System. We described reported cases of Bell's palsy among vaccine recipients (aged 18-110 years for CoronaVac and aged 16-110 years for BNT162b2). We compared the estimated age-standardised incidence of clinically confirmed cases among individuals who had received the CoronaVac or BNT162b2 vaccination (up to 42 days before presentation) with the background incidence in the population. A nested case-control study was also done using conditional logistic regression to estimate the odds ratio (OR) for risk of Bell's palsy and vaccination. Cases and controls were matched (1:4) by age, sex, admission setting, and admission date. FINDINGS: Between February 23 and May 4, 2021, 451 939 individuals received the first dose of CoronaVac and 537 205 individuals received the first dose of BNT162b2. 28 clinically confirmed cases of Bell's palsy were reported following CoronaVac and 16 cases were reported following BNT162b2. The age-standardised incidence of clinically confirmed Bell's palsy was 66·9 cases per 100 000 person-years (95% CI 37·2 to 96·6) following CoronaVac vaccination and 42·8 per 100 000 person-years (19·4 to 66·1) for BNT162b2 vaccination. The age-standardised difference for the incidence compared with the background population was 41·5 (95% CI 11·7 to 71·4) for CoronaVac and 17·0 (-6·6 to 40·6) for BNT162b2, equivalent to an additional 4·8 cases per 100 000 people vaccinated for CoronaVac and 2·0 cases per 100 000 people vaccinated for BNT162b2. In the nested case-control analysis, 298 cases were matched to 1181 controls, and the adjusted ORs were 2·385 (95% CI 1·415 to 4·022) for CoronaVac and 1·755 (0·886 to 3·477) for BNT162b2. INTERPRETATION: Our findings suggest an overall increased risk of Bell's palsy after CoronaVac vaccination. However, the beneficial and protective effects of the inactivated COVID-19 vaccine far outweigh the risk of this generally self-limiting adverse event. Additional studies are needed in other regions to confirm our findings. FUNDING: The Food and Health Bureau of the Government of the Hong Kong Special Administrative Region, China. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.