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1.
Lancet ; 399(10339): 1954-1963, 2022 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-35461618

RESUMO

BACKGROUND: New surgical procedures can expose patients to harm and should be carefully evaluated before widespread use. The InSpace balloon (Stryker, USA) is an innovative surgical device used to treat people with rotator cuff tears that cannot be repaired. We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears. METHODS: We conducted a double-blind, group-sequential, adaptive randomised controlled trial in 24 hospitals in the UK, comparing arthroscopic debridement of the subacromial space with biceps tenotomy (debridement only group) with the same procedure but including insertion of the InSpace balloon (debridement with device group). Participants had an irreparable rotator cuff tear, which had not resolved with conservative treatment, and they had symptoms warranting surgery. Eligibility was confirmed intraoperatively before randomly assigning (1:1) participants to a treatment group using a remote computer system. Participants and assessors were masked to group assignment. Masking was achieved by using identical incisions for both procedures, blinding the operation note, and a consistent rehabilitation programme was offered regardless of group allocation. The primary outcome was the Oxford Shoulder Score at 12 months. Pre-trial simulations using data from early and late timepoints informed stopping boundaries for two interim analyses. The primary analysis was on a modified intention-to-treat basis, adjusted for the planned interim analysis. The trial was registered with ISRCTN, ISRCTN17825590. FINDINGS: Between June 1, 2018, and July 30, 2020, we assessed 385 people for eligibility, of which 317 were eligible. 249 (79%) people consented for inclusion in the study. 117 participants were randomly allocated to a treatment group, 61 participants to the debridement only group and 56 to the debridement with device group. A predefined stopping boundary was met at the first interim analysis and recruitment stopped with 117 participants randomised. 43% of participants were female, 57% were male. We obtained primary outcome data for 114 (97%) participants. The mean Oxford Shoulder Score at 12 months was 34·3 (SD 11·1) in the debridement only group and 30·3 (10·9) in the debridement with device group (mean difference adjusted for adaptive design -4·2 [95% CI -8·2 to -0·26];p=0·037) favouring control. There was no difference in adverse events between the two groups. INTERPRETATION: In an efficient, adaptive trial design, our results favoured the debridement only group. We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears. FUNDING: Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership.


Assuntos
Lesões do Manguito Rotador , Artroscopia/métodos , Feminino , Humanos , Masculino , Músculo Esquelético , Lesões do Manguito Rotador/cirurgia , Ombro , Dor de Ombro/cirurgia , Resultado do Tratamento
2.
Bone Jt Open ; 3(3): 268-274, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35321559

RESUMO

Recognized anatomic variations that lead to patella instability include patella alta and trochlea dysplasia. Lateralization of the extensor mechanism relative to the trochlea is often considered to be a contributing factor; however, controversy remains as to the degree this contributes to instability and how this should be measured. As the tibial tuberosity-trochlear groove (TT-TG) is one of most common imaging measurements to assess lateralization of the extensor mechanism, it is important to understand its strengths and weaknesses. Care needs to be taken while interpreting the TT-TG value as it is affected by many factors. Medializing tibial tubercle osteotomy is sometimes used to correct the TT-TG, but may not truly address the underlying anatomical problem. This review set out to determine whether the TT-TG distance sufficiently summarizes the pathoanatomy, and if this assists with planning of surgery in patellar instability. Cite this article: Bone Jt Open 2022;3(3):268-274.

3.
Artigo em Inglês | MEDLINE | ID: mdl-35020088

RESUMO

PURPOSE: To systematically review the effect of PRP on healing (vascularization, inflammation and ligamentization) and clinical outcomes (pain, knee function and stability) in patients undergoing ACL reconstruction and compare the preparation and application of PRP. METHODS: Independent systematic searches of online databases (Medline, Embase and Web of Science) were conducted following PRISMA guidelines (final search 10th July 2021). Studies were screened against inclusion criteria and risk of bias assessed using Critical appraisal skills programme (CASP) Randomised controlled trial (RCT) checklist. Independent data extraction preceded narrative analysis. RESULTS: 13 RCTs were included. The methods of PRP collection and application were varied. Significant early increases in rate of ligamentization and vascularisation were observed alongside early decreases in inflammation. No significant results were achieved in the later stages of the healing process. Significantly improved pain and knee function was found but no consensus reached. CONCLUSIONS: PRP influences healing through early vascularisation, culminating in higher rates of ligamentization. Long-term effects were not demonstrated suggesting the influence of PRP is limited. No consensus was reached on the impact of PRP on pain, knee stability and resultant knee function, providing avenues for further research. Subsequent investigations could incorporate multiple doses over time, more frequent observation and comparisons of different forms of PRP. The lack of standardisation of PRP collection and application techniques makes comparison difficult. Due to considerable heterogeneity, (I2 > 50%), a formal meta-analysis was not possible highlighting the need for further high quality RCTs to assess the effectiveness of PRP. The biasing towards young males highlights the need for a more diverse range of participants to make the study more applicable to the general population. TRAIL REGISTRATION: CRD42021242078CRD, 15th March 2021, retrospectively registered.

4.
Eur J Orthop Surg Traumatol ; 32(4): 619-630, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-34052898

RESUMO

INTRODUCTION: There has been an increase in research on the effectiveness of treatment options for the management of meniscal tears. However, there is very little evidence about the patient experiences of meniscal tears. AIM: To summarise the available qualitative evidence on patients' experiences and expectations of meniscal tears. METHOD: A search of EMBASE, Medline, Sociofile and Web of Science up to November 2020 was performed to identify studies reporting patient experiences of meniscal tears. Studies were critically appraised using the CASP (Critical Appraisal Skills Program) checklist, and a meta-synthesis was performed to generate third-order constructs (new themes). RESULTS: Two studies reporting semi-structured interviews from 34 participants (24 male; 10 female) were included. The mean interview length ranged from 16 to 45 min. Five themes were generated: (1) the imaging (MRI) results are a key driver in the decision-making process, (2) surgery is perceived to be the definitive and quicker approach, (3) physiotherapy and exercise is a slower approach which brought success over time, (4) patient perceptions and preferences are important in the clinical decision-making process and, (5) the impact on patient lives is a huge driver in seeking care and treatment decisions. CONCLUSION: This is the first study to summarise the qualitative evidence on patient experiences with meniscal tears. The themes generated demonstrate the importance of patient perceptions of MRI findings and timing of treatment success as important factors in the decision-making process. This study demonstrates the need to strengthen our understanding of patients' experiences of meniscal tears.


Assuntos
Traumatismos do Joelho , Tomada de Decisão Clínica , Feminino , Humanos , Traumatismos do Joelho/terapia , Masculino
5.
Knee Surg Relat Res ; 33(1): 26, 2021 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-34419162

RESUMO

PURPOSE: The purpose of this study was to investigate the outcomes of management of mucoid degeneration of the anterior cruciate ligament (MDACL) by performing a systematic review of methods of treatment that have been reported. METHODS: A systematic literature search in the databases MEDLINE, Embase, Google Scholar, Cochrane, ISI web of science and Scopus was performed through July 2020 by three independent reviewers. The review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines and registered in the PROSPERO database (CRD42018087782). Quality was assessed using the Methodological Index for Non-Randomized Studies (MINORS) criteria. RESULTS: A total of nine studies were eligible for review. All nine studies assessed the outcome of arthroscopic debridement of MDACL. A total of 313 knees in 292 patients were included. The mean follow up ranged from 13 to 72 months. There was strong association between MDACL and chondral lesions (82%) and between MDACL and meniscal tears (69%). The rate of simultaneous meniscectomy ranged from 13 to 44%. Postoperative pain relief ranged from 53.8 to 95%. There was an improvement in postoperative range of motion and outcome scores (Lysholm and International Knee Documentation Committee scores and the Knee Injury and Osteoarthritis Outcome Score). Postoperative Lachman test was positive in 40% of patients, and 6% of patients had symptomatic instability. The mean MINORS score was 9.5 out of 16 (4-12). CONCLUSIONS: Arthroscopic debridement of the anterior cruciate ligament (ACL) results in satisfactory pain relief and improvement in knee outcome scores. Postoperative ACL laxity is common after arthroscopic ACL debridement, however, symptomatic instability is not. The need for delayed ACL reconstruction should be discussed preoperatively, especially if complete resection of the ACL is to be performed. LEVEL OF EVIDENCE: IV.

6.
Sci Adv ; 7(35)2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34452919

RESUMO

The metabolic mechanisms involved in the survival of tumor cells within the hypoxic niche remain unclear. We carried out a synthetic lethal CRISPR screen to identify survival mechanisms governed by the tumor hypoxia-induced pH regulator carbonic anhydrase IX (CAIX). We identified a redox homeostasis network containing the iron-sulfur cluster enzyme, NFS1. Depletion of NFS1 or blocking cyst(e)ine availability by inhibiting xCT, while targeting CAIX, enhanced ferroptosis and significantly inhibited tumor growth. Suppression of CAIX activity acidified intracellular pH, increased cellular reactive oxygen species accumulation, and induced susceptibility to alterations in iron homeostasis. Mechanistically, inhibiting bicarbonate production by CAIX or sodium-driven bicarbonate transport, while targeting xCT, decreased adenosine 5'-monophosphate-activated protein kinase activation and increased acetyl-coenzyme A carboxylase 1 activation. Thus, an alkaline intracellular pH plays a critical role in suppressing ferroptosis, a finding that may lead to the development of innovative therapeutic strategies for solid tumors to overcome hypoxia- and acidosis-mediated tumor progression and therapeutic resistance.


Assuntos
Bicarbonatos , Neoplasias , Liases de Carbono-Enxofre , Anidrase Carbônica IX , Hipóxia Celular , Linhagem Celular Tumoral , Humanos , Hipóxia , Ferro , Neoplasias/genética
7.
BMJ Open ; 11(6): e045353, 2021 06 09.
Artigo em Inglês | MEDLINE | ID: mdl-34108163

RESUMO

OBJECTIVE: Tourniquet use in total knee replacement (TKR) is believed to improve the bone-cement interface by reducing bleeding, potentially prolonging implant survival. This study aimed to compare the risk of revision for primary cemented TKR performed with or without a tourniquet. DESIGN: We analysed data from the National Joint Registry (NJR) for all primary cemented TKRs performed in England and Wales between April 2003 and December 2003. Kaplan-Meier plots and Cox regression were used to assess the influence of tourniquet use, age at time of surgery, sex and American Society of Anaesthesiologists (ASA) classification on risk of revision for all-causes. RESULTS: Data were available for 16 974 cases of primary cemented TKR, of which 16 132 had surgery with a tourniquet and 842 had surgery without a tourniquet. At 10 years, 3.8% had undergone revision (95% CI 2.6% to 5.5%) in the no-tourniquet group and 3.1% in the tourniquet group (95% CI 2.8% to 3.4%). After adjusting for age at primary surgery, gender and primary ASA score, the HR for all-cause revision for cemented TKR without a tourniquet was 0.82 (95% CI 0.57 to 1.18). CONCLUSIONS: We did not find evidence that using a tourniquet for primary cemented TKR offers a clinically important or statistically significant reduction in the risk of all-cause revision up to 13 years after surgery. Surgeons should consider this evidence when deciding whether to use a tourniquet for cemented TKR.


Assuntos
Artroplastia do Joelho , Prótese do Joelho , Artroplastia do Joelho/efeitos adversos , Inglaterra , Humanos , Falha de Prótese , Sistema de Registros , Reoperação , Torniquetes , País de Gales
8.
Curr Oncol ; 28(3): 1962-1979, 2021 05 24.
Artigo em Inglês | MEDLINE | ID: mdl-34073974

RESUMO

Pancreatic cancer is one of the deadliest types of cancer, with a five-year survival rate of only 10%. Nanotechnology offers a novel perspective to treat such deadly cancers through their incorporation into radiotherapy and chemotherapy. However, the interaction of nanoparticles (NPs) with cancer cells and with other major cell types within the pancreatic tumor microenvironment (TME) is yet to be understood. Therefore, our goal is to shed light on the dynamics of NPs within a TME of pancreatic origin. In addition to cancer cells, normal fibroblasts (NFs) and cancer-associated fibroblasts (CAFs) were examined in this study due to their important yet opposite roles of suppressing tumor growth and promoting tumor growth, respectively. Gold nanoparticles were used as the model NP system due to their biocompatibility and physical and chemical proprieties, and their dynamics were studied both quantitatively and qualitatively in vitro and in vivo. The in vitro studies revealed that both cancer cells and CAFs take up 50% more NPs compared to NFs. Most importantly, they all managed to retain 70-80% of NPs over a 24-h time period. Uptake and retention of NPs within an in vivo environment was also consistent with in vitro results. This study shows the paradigm-changing potential of NPs to combat the disease.


Assuntos
Nanopartículas Metálicas , Neoplasias Pancreáticas , Ouro , Humanos , Nanomedicina , Neoplasias Pancreáticas/tratamento farmacológico , Microambiente Tumoral
10.
Injury ; 52(6): 1251-1259, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33691946

RESUMO

BACKGROUND: Open tibia fractures are a common injury following road traffic collisions and place a large economic burden on patients and healthcare systems. Summarising their economic burden is key to inform policy and help prioritise treatment. METHODS: All studies were identified from a systematic search of Medline, Embase and the Cochrane Central Register of Controlled Trials. We included any human with a diagnosed open tibia fracture, following any intervention. The primary outcome was any costs reported or patient return to work status. Secondary outcomes included average length of stay, wage loss, absenteeism and complications such as infection, amputation and nonunion. Data was extracted and we performed a descriptive narrative summary. RESULTS: We reviewed 1,204 studies from our searches. A total of 34 studies were included from 14 different countries. The average age was 37.7 years old and 76% of the patients were male. 6.5% were Gustilo I, 12% Gustilo II and 82% Gustilo III. Initial direct hospitalisation costs were reported to be between £356 to £126,479 with an average length of stay of 56 days (3.1-244). 89% of participants were working pre-injury, 60% fully returned to work, 17% returned to work part time or changed profession and 22% did not return to work at one-year. The most common complications reported were 22% infection, 11% nonunion and 16% amputation. Mean follow-up duration for the studies was 25 months. CONCLUSION: The economic burden of open tibia fractures varies greatly, but it is costly for both hospitals and patients. The current evidence is predominantly from high-income countries (HICs), especially the USA. Further research is required to investigate the costs of open tibia fractures using validated costing tools, especially in low-income countries (LICs), to help inform and direct policy.


Assuntos
Fraturas Expostas , Fraturas da Tíbia , Acidentes de Trânsito , Adulto , Amputação , Efeitos Psicossociais da Doença , Feminino , Fraturas Expostas/cirurgia , Humanos , Masculino , Tíbia , Fraturas da Tíbia/cirurgia
11.
Knee ; 29: 305-312, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33677155

RESUMO

BACKGROUND: The aim of this consensus process was to provide robust national guidelines to assist with decision making with regards to surgical management of patellofemoral instability. METHODS: A national group of surgeons, physiotherapists, basic scientists and a radiologist with expert experience in patellofemoral instability was convened. A formal consensus process was undertaken using validated methodology. They reviewed the existing literature, performed a group consensus meeting to develop recommendations and followed this with a wider consultation meeting with an open invitation for final ratification. The guidelines were reviewed and authorised by the BASK executive committee, followed by the British Orthopaedic Association prior to final publication. RESULTS: The review of the literature confirmed a significant absence of an evidence base to guide clinicians in the surgical management of patellofemoral instability. The consensus process outlined guidance relating to diagnosis and clinical assessment, appropriate imaging modalities, recommendations for surgical options and appropriate post operative physiotherapy. Following wide invitation to contribute to the final document, 102 people responded. Twenty six of those provided additional comments which were blinded, discussed and included or excluded following further discussion amongst the working group. CONCLUSION: Patellofemoral instability is a complex pathology with multiple surgical options available to those who decide surgery is indicated. In the absence of a strong evidence base, these guidelines aim to assist with that decision making process and will pave the way for more robust clinical trials in the future.


Assuntos
Instabilidade Articular/cirurgia , Articulação Patelofemoral/cirurgia , Humanos , Instabilidade Articular/diagnóstico , Procedimentos Ortopédicos , Articulação Patelofemoral/diagnóstico por imagem , Modalidades de Fisioterapia , Cuidados Pós-Operatórios
12.
J Clin Med ; 10(4)2021 Feb 12.
Artigo em Inglês | MEDLINE | ID: mdl-33673218

RESUMO

The aim of this study is to provide reliable guidelines for the mean percentage efficacy together with the 95% credibility interval in slowing down progression of myopia by a specific intervention over defined time periods, derived from a substantial number of randomised controlled clinical trials (RCTs) with consistent outcomes. Multifocal spectacles and contact lenses represent interventions with the largest number of RCTs carried out. Our meta-analyses considered 10 RCTs involving 1662 children which have tested the efficacy of progressive addition spectacle lenses (PALs). In a separate model for comparison purposes nine RCTs with 982 children trialling soft multifocal contact lenses (MFCLs) were analysed. Bayesian random-effects hierarchical models were fitted. The highest efficacy in retarding progression of the scaled sphere equivalent refraction was achieved after 12 M follow-up with the mean 28% reduction in progression and the 95% credibility interval between 21% and 35%. For comparison, the 95% credibility interval for the mean efficacy of soft MFCLs at 12 M follow up is 21% to 37%. We conclude that both multifocal spectacle and contact lenses moderately slow down progression of myopia, relative to single-vision spectacle lenses (SVLs) in the first 12 months after intervention. The relative efficacy of PALs tends to weaken after the first 12 months.

13.
Bone Joint J ; 103-B(5): 830-839, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33683139

RESUMO

AIMS: Many surgeons choose to perform total knee arthroplasty (TKA) surgery with the aid of a tourniquet. A tourniquet is a device that fits around the leg and restricts blood flow to the limb. There is a need to understand whether tourniquets are safe, and if they benefit, or harm, patients. The aim of this study was to determine the benefits and harms of tourniquet use in TKA surgery. METHODS: We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled trials, and trial registries up to 26 March 2020. We included randomized controlled trials (RCTs), comparing TKA with a tourniquet versus without a tourniquet. Outcomes included: pain, function, serious adverse events (SAEs), blood loss, implant stability, duration of surgery, and length of hospital stay. RESULTS: We included 41 RCTs with 2,819 participants. SAEs were significantly more common in the tourniquet group (53/901 vs 26/898, tourniquet vs no tourniquet respectively) (risk ratio 1.73 (95% confidence interval (CI) 1.10 to 2.73). The mean pain score on the first postoperative day was 1.25 points higher (95% CI 0.32 to 2.19) in the tourniquet group. Overall blood loss did not differ between groups (mean difference 8.61 ml; 95% CI -83.76 to 100.97). The mean length of hospital stay was 0.34 days longer in the group that had surgery with a tourniquet (95% CI 0.03 to 0.64) and the mean duration of surgery was 3.7 minutes shorter (95% CI -5.53 to -1.87). CONCLUSION: TKA with a tourniquet is associated with an increased risk of SAEs, pain, and a marginally longer hospital stay. The only finding in favour of tourniquet use was a shorter time in theatre. The results make it difficult to justify the routine use of a tourniquet in TKA surgery. Cite this article: Bone Joint J 2021;103-B(5):830-839.


Assuntos
Artroplastia do Joelho , Perda Sanguínea Cirúrgica/prevenção & controle , Hemostasia Cirúrgica/instrumentação , Torniquetes , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Amplitude de Movimento Articular , Torniquetes/efeitos adversos
14.
Knee ; 29: 557-563, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33774589

RESUMO

BACKGROUND: Magnetic resonance imaging (MRI) is one of the most widely used investigations for knee pain as it provides detailed assessment of the bone and soft tissues. The aim of this study is to report the frequency of each diagnosis identified on MRI scans of the knee and explore the relationship between MRI results and onward treatment. METHODS: Consecutive MRI reports from a large NHS trust performed in 2017 were included in this study. The hospital electronic system was consulted to identify whether a patient underwent x-ray prior to the MRI, attended an outpatient appointment or underwent surgery. RESULTS: 4466 MRI knees were performed in 2017 with 71.2% requested in primary care and 28.1% requested in secondary care. The most common diagnosis was signs of arthritis (55.2%), followed by meniscal tears (42.8%) and ACL tears (8.3%). 49.4% of patients who had an MRI attended outpatients and 15.6% underwent surgery. The rate of knee surgery was significantly higher for patients who had their scans requested in secondary care (32.9% vs 8.9%, p < 0.001). CONCLUSION: The rate of surgical intervention following MRI is low and given these results it seems unlikely that the scan changes practice in most cases. The rate of surgery and outpatient follow up was significantly higher in scans requested by secondary care. We urge clinicians avoid wasteful use of MRI and recommend the use of plain radiography prior to MRI where arthritis may be present.


Assuntos
Artrite/diagnóstico por imagem , Traumatismos do Joelho/diagnóstico por imagem , Joelho/diagnóstico por imagem , Adulto , Idoso , Lesões do Ligamento Cruzado Anterior/diagnóstico por imagem , Lesões do Ligamento Cruzado Anterior/epidemiologia , Lesões do Ligamento Cruzado Anterior/cirurgia , Artrite/epidemiologia , Feminino , Humanos , Joelho/cirurgia , Traumatismos do Joelho/epidemiologia , Traumatismos do Joelho/cirurgia , Imageamento por Ressonância Magnética/métodos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Medicina Estatal/estatística & dados numéricos , Reino Unido
15.
Knee Surg Sports Traumatol Arthrosc ; 29(11): 3892-3898, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33521890

RESUMO

PURPOSE: The management of meniscal tears is a widely researched and evolving field. Previous studies reporting the incidence of meniscal tears are outdated and not representative of current practice. The aim of this study was to report the current incidence of MRI confirmed meniscal tears in patients with a symptomatic knee and the current intervention rate in a large NHS trust. METHODS: Radiology reports from 13,358 consecutive magnetic resonance imaging scans between 2015 and 2017, performed at a large UK hospital serving a population of 470,000, were assessed to identify patients with meniscal tears. The hospital database was interrogated to explore the subsequent treatment undertaken by the patient. A linear regression model was used to identify if any factors predicted subsequent arthroscopy. RESULTS: 1737 patients with isolated meniscal tears were identified in patients undergoing an MRI for knee pain, suggesting a rate of 222 MRI confirmed tears per 100,000 of the population aged 18 to 55 years old. 47% attended outpatient appointments and 22% underwent arthroscopy. Root tears [odds ratio (95% CI) 2.24 (1.0, 4.49); p = 0.049] and bucket handle tears were significantly associated with subsequent surgery, with no difference between the other types of tears. The presence of chondral changes did not significantly affect the rate of surgery [0.81 (0.60, 1.08); n.s]. CONCLUSION: Meniscal tears were found to be more common than previously described. However, less than half present to secondary care and only 22% undergo arthroscopy. These findings should inform future study design and recruitment strategies. In agreement with previous literature, bucket handle tears and root tears were significant predictors of subsequent surgery. LEVEL OF EVIDENCE: III.


Assuntos
Traumatismos do Joelho , Lesões do Menisco Tibial , Adolescente , Adulto , Artroscopia , Humanos , Traumatismos do Joelho/diagnóstico , Traumatismos do Joelho/epidemiologia , Traumatismos do Joelho/cirurgia , Imageamento por Ressonância Magnética , Meniscos Tibiais , Pessoa de Meia-Idade , Estudos Retrospectivos , Lesões do Menisco Tibial/diagnóstico por imagem , Lesões do Menisco Tibial/epidemiologia , Lesões do Menisco Tibial/cirurgia , Adulto Jovem
16.
BMJ Open ; 11(1): e043564, 2021 01 22.
Artigo em Inglês | MEDLINE | ID: mdl-33483447

RESUMO

INTRODUCTION: Tourniquets are routinely used during total knee replacement (TKR) surgery. They could increase the risk of thromboembolic events including cerebral emboli, cognitive decline, pain and other adverse events (AEs). A randomised controlled trial to assess whether tourniquet use might safely be avoided is therefore warranted but it is unclear whether such a trial would be feasible. METHODS: In a single-site feasibility study and pilot randomised controlled trial, adults having a TKR were randomised to surgery with an inflated tourniquet versus a non-inflated tourniquet. Participants underwent brain MRI preoperatively and within 2 days postoperatively. We assessed cognition using the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Oxford Cognitive Screen (OCS) and thigh pain using a Visual Analogue Scale at baseline and days 1 and 2, and 1 week postsurgery. AEs related to surgery were recorded up to 12 months. RESULTS: We randomised 53 participants (27 tourniquet inflated and 26 tourniquet not inflated). Fifty-one participants received care per-protocol (96%) and 48 (91%) were followed up at 12 months. One new ischaemic brain lesion was detected. Of the cognitive tests, MoCA was easy to summarise, sensitive to change with lower ceiling effects compared with OCS and MMSE. There was a trend towards more thigh pain (mean 49.6 SD 30.4 vs 36.2 SD 28 at day 1) and more AEs related to surgery (21 vs 9) in participants with an inflated tourniquet compared with those with a tourniquet not inflated. CONCLUSION: A full trial is feasible, but using MRI as a primary outcome is unlikely to be appropriate or feasible. Suitable primary outcomes would be cognition measured using MoCA, pain and AEs, all of which warrant investigation in a large multicentre trial. TRIAL REGISTRATION NUMBER: ISRCTN20873088.


Assuntos
Artroplastia do Joelho , Torniquetes , Adulto , Artroplastia do Joelho/efeitos adversos , Estudos de Viabilidade , Feminino , Humanos , Projetos Piloto , Resultado do Tratamento
17.
Wellcome Open Res ; 6: 228, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-35505977

RESUMO

Background: Road traffic injury (RTI) is the largest cause of death amongst 15-39-year-old people worldwide, and the burden of injuries such as open tibia fractures are rapidly increasing in Malawi. This study aims to investigate disability and economic outcomes of people with open tibia fractures in Malawi and improve these with locally delivered implementation of open fracture guidelines. Methods: This is a prospective cohort study describing function, quality of life and economic burden of open tibia fractures in Malawi. In total, 160 participants will be recruited across six centres and will be followed-up with face-to-face interviews at six weeks, three months, six months and one year following injury. The primary outcome will be function at one year measured by the short musculoskeletal functional assessment (SMFA) score. Secondary outcomes will include quality of life measured by EuroQol EQ-5D-3L, catastrophic loss of income and implementation outcomes (acceptability, adoption, appropriateness, costs, feasibility, fidelity, penetration, and sustainability) at one year. A nested pilot pre-post implementation study of an interventional bundle for all open fractures will be developed based on other implementation studies from low- and middle-income countries (LMICs). Regression analysis will be used to model and investigate associations between SMFA score and fracture severity, infection and the pre- and post-training course period. Outcome: This prospective cohort study will report patient reported outcomes from open tibia fractures in low-resource settings. Subsequent detailed evaluation of both the clinical and implementation components of the study will promote sustainability of improved open fractures management in the study sites and further scale-up of open fracture management guidelines. Ethics: Ethics approval has been obtained from the Liverpool School of Tropical Medicine and College of Medicine Research and Ethics committee.

18.
Cochrane Database Syst Rev ; 12: CD012874, 2020 12 08.
Artigo em Inglês | MEDLINE | ID: mdl-33316105

RESUMO

BACKGROUND: Many surgeons prefer to perform total knee replacement surgery with the aid of a tourniquet. A tourniquet is an occlusive device that restricts distal blood flow to help create a bloodless field during the procedure. A tourniquet may be associated with increased risk of pain and complications. OBJECTIVES: To determine the benefits and harms of tourniquet use in knee replacement surgery. SEARCH METHODS: We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) up to 26 March 2020. We searched clinicaltrials.gov, the World Health Organization trials portal, and several international registries and joint registries up to March 2020. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing knee replacement with use of a tourniquet versus without use of a tourniquet and non-randomised studies with more than 1000 participants. Major outcomes included pain, function, global assessment of success, health-related quality of life, serious adverse events (including venous thromboembolism, infection, re-operation, and mortality), cognitive function, and survival of the implant. Minor outcomes included blood loss, economic outcomes, implant stability, and adverse events. DATA COLLECTION AND ANALYSIS: Two review authors screened abstracts and full texts, extracted data, performed risk of bias assessments, and assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included 41 RCTs with 2819 participants. Trials included from 20 to 199 participants. Mean age ranged between 58 and 84 years. More than half of the RCTs had unclear risk of selection bias and unclear risk of performance and detection bias due to absence of blinding of participants and surgeons. Major outcomes Pain: at postoperative day 1, pain (on a scale from zero to 10, with higher scores indicating worse pain) was ranked at 4.56 points after surgery without a tourniquet and at 1.25 points (MD) higher (95% CI 0.32 higher to 2.19 higher) with a tourniquet (8 studies; 577 participants), for an absolute difference of 12.5% higher pain scores (95% CI 3.2% higher to 21.9% higher) and a relative difference of 19% higher pain scores (95% CI 3.4% higher to 49% higher) with a tourniquet. Evidence for these findings was of moderate certainty, downgraded due to risk of bias. Knee replacement with a tourniquet probably led to higher postoperative pain scores at day 1, although this difference may or may not be noticeable to patients (based on a minimal clinically important difference (MCID) of 1.0). Function: at 12 months, tourniquet use probably makes little or no difference to function, based on an MCID of 5.3 for Knee Society Score (KSS) and 5.0 for Oxford Knee Score (OKS). Mean function (on a scale from 0 to 100, with higher scores indicating better outcomes) was 90.03 points after surgery without a tourniquet and was 0.29 points worse (95% CI 1.06 worse to 0.48 better) on a 0 to 100 scale, absolute difference was 0.29% worse (1.06% worse to 0.48% better), with a tourniquet (5 studies; 611 participants). This evidence was downgraded to moderate certainty due to risk of bias. Global assessment of success: low-certainty evidence (downgraded due to bias and imprecision) indicates that tourniquet use may have little or no effect on success. At six months, 47 of 50 (or 940 per 1000) reported overall successful treatment after surgery without a tourniquet and 47 of 50 (or 940 per 1000) with a tourniquet (risk ratio (RR) 1.0, 95% CI 0.91 to 1.10) based on one study with 100 participants. Health-related quality of life: at six months, tourniquet may have little or no effect on quality of life. The 12-Item Short Form Survey (SF-12) score (mental component from zero to 100 (100 is best)) was 54.64 after surgery without a tourniquet and 1.53 (MD) better (95% CI 0.85 worse to 3.91 better) with a tourniquet (1 study; 199 participants); absolute difference was 1.53% better (0.85% worse to 3.91% better). Evidence was of low certainty, downgraded due to risk of bias and small number of participants. Serious adverse events: the risk of serious adverse events was probably higher with tourniquet; 26 of 898 (29 per 1000) reported events following surgery without a tourniquet compared to 53 of 901 (59 per 1000) with a tourniquet (RR 1.73, 95% CI 1.10 to 2.73) in 21 studies (1799 participants). Twenty-nine more per 1000 patients (95% CI 3 to 50 more per 1000 patients) had a serious adverse event with a tourniquet. Forty-eight (95% CI 20 to 345) participants would need to have surgery without a tourniquet to avoid one serious adverse event. This evidence was downgraded to moderate certainty due to risk of bias. Cognitive function: one study reported cognitive function as an outcome; however the data were incompletely reported and could not be extracted for analysis. Survival of implant: it is uncertain if tourniquet has an effect on implant survival due to very low certainty evidence (downgraded for bias, and twice due to very low event rates); 2 of 107 (19 per 1000) required revision surgery in the surgery with a tourniquet group compared to 1 of 107 (9 per 1000) without a tourniquet group at up to two years' follow-up (RR 1.44, 95% CI 0.23 to 8.92). This equates to a 0.4% (0.7% lower to 7% more) increased absolute risk in surgery with a tourniquet. AUTHORS' CONCLUSIONS: Moderate certainty evidence shows that knee replacement surgery with a tourniquet is probably associated with an increased risk of serious adverse events. Surgery with a tourniquet is also probably associated with higher postoperative pain, although this difference may or may not be noticeable to patients. Surgery with a tourniquet does not appear to confer any clinically meaningful benefit on function, treatment success or quality of life. Further research is required to explore the effects of tourniquet use on cognitive function and implant survival, to identify any additional harms or benefits. If a tourniquet continues to be used in knee replacement surgery, patients should be informed about the potential increased risk of serious adverse events and postoperative pain.


ANTECEDENTES: Muchos cirujanos prefieren realizar una cirugía de reemplazo total de rodilla con la ayuda de un torniquete. Un torniquete es un dispositivo oclusivo que restringe el flujo sanguíneo distal para ayudar a crear un campo sin sangre durante el procedimiento. El torniquete se puede asociar con un mayor riesgo de dolor y complicaciones. OBJETIVOS: Determinar los efectos beneficiosos y perjudiciales del uso de torniquetes en la cirugía de reemplazo de rodilla. MÉTODOS DE BÚSQUEDA: Se hicieron búsquedas en MEDLINE, Embase y en el Registro Cochrane central de ensayos controlados (CENTRAL) hasta el 26 de marzo de 2020. Se realizaron búsquedas en clinicaltrials.gov, el portal de ensayos de la Organización Mundial de la Salud, y en varios registros internacionales y registros conjuntos hasta marzo de 2020. CRITERIOS DE SELECCIÓN: Se incluyeron los ensayos controlados aleatorizados (ECA) que compararon el reemplazo de rodilla con el uso de un torniquete versus sin el uso de un torniquete y los estudios no aleatorizados con más de 1000 participantes. Los desenlaces principales fueron el dolor, la funcionalidad, la evaluación general del éxito, la calidad de vida relacionada con la salud, los eventos adversos graves (incluido el tromboembolismo venoso, la infección, la reintervención y la mortalidad), la función cognitiva y la supervivencia del implante. Los desenlaces secundarios incluyeron la pérdida de sangre, los desenlaces económicos, la estabilidad del implante y los eventos adversos. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Dos autores de la revisión examinaron los resúmenes y los textos completos, extrajeron los datos, realizaron las evaluaciones del riesgo de sesgo y evaluaron la certeza de la evidencia utilizando el enfoque GRADE. RESULTADOS PRINCIPALES: Se incluyeron 41 ECA con 2819 participantes. Los ensayos incluyeron de 20 a 199 participantes. La media de edad varió entre 58 y 84 años. Más de la mitad de los ECA tenían riesgo incierto de sesgo de selección y riesgo incierto de sesgo de realización y detección debido a la falta de cegamiento de los participantes y los cirujanos. Desenlaces principales Dolor: en el primer día después de la cirugía, el dolor (en una escala de 0 a 10, con puntuaciones mayores que indican un peor dolor) se clasificó en 4,56 puntos después de la cirugía sin torniquete y en 1,25 puntos (DM) mayor (IC del 95%: 0,32 mayor a 2,19 mayor) con un torniquete (ocho estudios; 577 participantes), para una diferencia absoluta de 12,5% de puntuaciones mayores de dolor (IC del 95%: 3,2% mayor a 21,9% mayor) y una diferencia relativa de 19% de puntuaciones mayores de dolor (IC del 95%: 3,4% mayor a 49% mayor) con un torniquete. La evidencia de estos hallazgos fue de certeza moderada, disminuida debido al riesgo de sesgo. El reemplazo de rodilla con un torniquete probablemente dio lugar a mayores puntuaciones de dolor en el primer día después de la cirugía, aunque esta diferencia puede o no ser perceptible para los pacientes (sobre la base de una diferencia mínima clínicamente importante [DMCI] de 1,0). Funcionalidad: a los 12 meses el uso de torniquetes probablemente da lugar a poca o ninguna diferencia en la funcionalidad, según una DMCI de 5,3 en la Knee Society Score (KSS) y de 5,0 en la Oxford Knee Score (OKS). La funcionalidad media (en una escala de 0 a 100, con puntuaciones más altas que indican mejores desenlaces) fue de 90,03 puntos después de la cirugía sin torniquete y fue 0,29 puntos peor (IC del 95%: 1,06 peor a 0,48 mejor) en una escala de 0 a 100, la diferencia absoluta fue 0,29% peor (1,06% peor a 0,48% mejor), con un torniquete (cinco estudios; 611 participantes). Esta evidencia se disminuyó a certeza moderada debido al riesgo de sesgo. Evaluación general del éxito: evidencia de certeza baja (disminuida debido al sesgo y la imprecisión) indica que el uso de torniquetes puede tener poco o ningún efecto en el éxito. A los seis meses, 47 de 50 (o 940 por 1000) informaron de un tratamiento general exitoso después de la cirugía sin torniquete y 47 de 50 (o 940 por 1000) con torniquete (razón de riesgos [RR] 1,0; IC del 95%: 0,91 a 1,10), según un estudio con 100 participantes. Calidad de vida relacionada con la salud: a los seis meses, el torniquete puede tener poco o ningún efecto en la calidad de vida. La puntuación de la 12­Item Short Form Survey (SF­12) (componente mental de 0 a 100 [100 es mejor]) fue de 54,64 después de la cirugía sin torniquete y 1,53 (DM) mejor (IC del 95%: 0,85 peor a 3,91 mejor) con torniquete (un estudio; 199 participantes); la diferencia absoluta fue 1,53% mejor (0,85% peor a 3,91% mejor). La evidencia fue de certeza baja, y se disminuyó debido al riesgo de sesgo y al escaso número de participantes. Eventos adversos graves: el riesgo de eventos adversos graves probablemente fue mayor con el uso de un torniquete; 26 de 898 (29 por 1000) notificaron eventos después de la cirugía sin torniquete en comparación con 53 de 901 (59 por 1000) con un torniquete (RR 1,73; IC del 95%: 1,10 a 2,73) en 21 estudios (1799 participantes). Veintinueve más por cada 1000 pacientes (95% CI 3 a 50 más por 1000 pacientes) presentaron un evento adverso grave con un torniquete. Cuarenta y ocho (IC del 95%: 20 a 345) participantes tendrían que ser operados sin torniquete para evitar un evento adverso grave. Esta evidencia se disminuyó a certeza moderada debido al riesgo de sesgo. Función cognitiva: un estudio informó de la función cognitiva como un desenlace; sin embargo, los datos se informaron de manera incompleta y no se pudieron extraer para el análisis. Supervivencia del implante: no está claro si el torniquete tiene un efecto sobre la supervivencia del implante debido a evidencia de certeza muy baja (disminuida por el sesgo, y dos veces debido a las tasas de eventos muy bajas); dos de 107 (19 por 1000) requirieron cirugía de revisión en el grupo de cirugía con torniquete en comparación con uno de 107 (nueve por 1000) en el grupo sin torniquete hasta los dos años de seguimiento (RR 1,44; IC del 95%: 0,23 a 8,92). Esto equivale a un 0,4% (0,7% menos a 7% más) de aumento del riesgo absoluto en la cirugía con torniquete. CONCLUSIONES DE LOS AUTORES: Evidencia de certeza moderada muestra que la cirugía de reemplazo de rodilla con torniquete probablemente se asocia con un mayor riesgo de eventos adversos graves. La cirugía con torniquete también se asocia probablemente con un mayor dolor posoperatorio, aunque esta diferencia puede o no ser perceptible para los pacientes. La cirugía con torniquete no parece conferir efectos beneficiosos clínicamente significativos en la funcionalidad, el éxito del tratamiento o la calidad de vida. Se necesitan estudios de investigación adicionales para explorar los efectos del uso de torniquetes en la función cognitiva y la supervivencia del implante, para identificar cualquier efecto perjudicial o beneficioso adicional. Si se sigue utilizando un torniquete en la cirugía de reemplazo de rodilla, se debe informar a los pacientes sobre el posible aumento del riesgo de que se produzcan efectos adversos graves y dolor posoperatorio.


Assuntos
Artroplastia do Joelho/efeitos adversos , Torniquetes/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Artroplastia do Joelho/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor/métodos , Dor Pós-Operatória/diagnóstico , Falha de Prótese , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Viés de Seleção , Resultado do Tratamento
19.
BMC Musculoskelet Disord ; 21(1): 754, 2020 Nov 16.
Artigo em Inglês | MEDLINE | ID: mdl-33198706

RESUMO

BACKGROUND: Planned lower limb surgery is common, with over 90,000 hip replacements, 95,000 knee replacements and 15,000 anterior cruciate ligament reconstructions performed in the UK each year. These procedures are primarily indicated to treat osteoarthritis, sporting injuries and trauma. Patient satisfaction is an important element of healthcare provision, which is usually measured by functional outcomes but influenced by other factors. Few studies have assessed patients' views on the information given to them pertaining surgery and patients are infrequently consulted when designing leaflets and information packs, which can lead to confusion during the recovery period and poor long-term outcomes. Furthermore, previous studies have not directly asked patients what resources they would prefer, or which format would suit them best. This project aimed to assess if patients were satisfied with the information they received around their operations and to identify potential improvements. METHODS: Set in a National Health Service (NHS) run major trauma centre in the West Midlands, a multiple choice and free-text answer survey was administered to patients who used the orthopaedic service over the course of 1 month. Surveys were designed in Qualtrics and administered face-to-face on paper. Thematic content analysis was performed on the results. RESULTS: Eighty patients completed the survey, of which 88.8% of patients were satisfied with the information they received. Discussions with surgeons were the most useful resource and 53% of patients requested more internet resources. Post-operative patients were statistically more likely to be dissatisfied with information provision than pre-operative patients. Over 20% of the study population requested more information on post-operative pain and recovery timelines. CONCLUSIONS: Although patients were satisfied in general, areas for change were identified. Suggested resources took the form of webpages and mobile platforms. These resources could contain educational videos, patient experience blogs or interactive recovery timelines, to be of benefit to patients. These suggestions may enable NHS Trusts to "get into the digital age", however, more research on patient satisfaction around information provision and the impact it has on recovery and decision making is needed.


Assuntos
Artroplastia do Joelho , Satisfação do Paciente , Humanos , Extremidade Inferior , Medicina Estatal , Inquéritos e Questionários
20.
J Biomech ; 112: 110042, 2020 11 09.
Artigo em Inglês | MEDLINE | ID: mdl-33038749

RESUMO

The purpose of this study was to quantify the effect of total knee replacement (TKR) alignment on in-vivo knee function and loading in a unique patient cohort who have been identified as having a high rate of component mal-alignment. Post-TKR (82.4 ± 6.7 months), gait analysis was performed on 25 patients (27 knees), to calculate knee kinematics and kinetics. For a step activity, video fluoroscopic analysis quantified in-vivo implant kinematics. Frontal plane lower-limb alignment was defined by the Hip-Knee-Ankle angle (HKA) measured on long leg static X-rays. Transverse plane component rotation was calculated from computed tomography scans. Sagittal plane alignment was defined by measuring the flexion angle of the femoral component and the posterior tibial slope angle (PTSA). For gait analysis, a more varus HKA correlated with increased peak and dynamic joint kinetics, predicting 47.6% of Knee Adduction Angular Impulse variance. For the step activity, during step-up and single leg loaded, higher PTSA correlated with a posterior shift in medial compartment Anterior-Posterior (AP) translation. During step-down, higher PTSA correlated with reduced lateral compartment AP translation with a posterior shift in AP translation in both compartments. A more varus HKA correlated with a more posterior medial AP translation and inter-component rotation was related to transverse plan range of motion. This in-vivo study found that frontal plane lower-limb alignment had a significant effect on joint forces during gait but had minimal influence on in-vivo implant kinematics for step activity. PTSA was found to influence in-vivo TKR translations and is therefore an important surgical factor.


Assuntos
Artroplastia do Joelho , Prótese do Joelho , Fenômenos Biomecânicos , Humanos , Articulação do Joelho/diagnóstico por imagem , Articulação do Joelho/cirurgia , Amplitude de Movimento Articular , Tíbia/cirurgia
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