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1.
Health Technol Assess ; 25(62): 1-126, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34780323

RESUMO

BACKGROUND: There is informal consensus that simple compression fractures of the body of the thoracolumbar vertebrae between the 10th thoracic vertebra and the second lumbar vertebra without neurological complications can be managed conservatively and that obvious unstable fractures require surgical fixation. However, there is a zone of uncertainty about whether surgical or conservative management is best for stable fractures. OBJECTIVES: To assess the feasibility of a definitive randomised controlled trial comparing surgical fixation with initial conservative management of stable thoracolumbar fractures without spinal cord injury. DESIGN: External randomised feasibility study, qualitative study and national survey. SETTING: Three NHS hospitals. METHODS: A feasibility randomised controlled trial using block randomisation, stratified by centre and type of injury (high- or low-energy trauma) to allocate participants 1 : 1 to surgery or conservative treatment; a costing analysis; a national survey of spine surgeons; and a qualitative study with clinicians, recruiting staff and patients. PARTICIPANTS: Adults aged ≥ 16 years with a high- or low-energy fracture of the body of a thoracolumbar vertebra between the 10th thoracic vertebra and the second lumbar vertebra, confirmed by radiography, computerised tomography or magnetic resonance imaging, with at least one of the following: kyphotic angle > 20° on weight-bearing radiographs or > 15° on a supine radiograph or on computerised tomography; reduction in vertebral body height of 25%; a fracture line propagating through the posterior wall of the vertebra; involvement of two contiguous vertebrae; or injury to the posterior longitudinal ligament or annulus in addition to the body fracture. INTERVENTIONS: Surgical fixation: open spinal surgery (with or without spinal fusion) or minimally invasive stabilisation surgery. Conservative management: mobilisation with or without a brace. MAIN OUTCOME MEASURE: Recruitment rate (proportion of eligible participants randomised). RESULTS: Twelve patients were randomised (surgery, n = 8; conservative, n = 4). The proportion of eligible patients recruited was 0.43 (95% confidence interval 0.24 to 0.63) over a combined total of 30.7 recruitment months. Of 211 patients screened, 28 (13.3%) fulfilled the eligibility criteria. Patients in the qualitative study (n = 5) expressed strong preferences for surgical treatment, and identified provision of information about treatment and recovery and when and how they are approached for consent as important. Nineteen surgeons and site staff participated in the qualitative study. Key themes were the lack of clinical consensus regarding the implementation of the eligibility criteria in practice and what constitutes a stable fracture, alongside lack of equipoise regarding treatment. Based on the feasibility study eligibility criteria, 77% (50/65) and 70% (46/66) of surgeons participating in the survey were willing to randomise for high- and low-energy fractures, respectively. LIMITATIONS: Owing to the small number of participants, there is substantial uncertainty around the recruitment rate. CONCLUSIONS: A definitive trial is unlikely to be feasible currently, mainly because of the small number of patients meeting the eligibility criteria. The recruitment and follow-up rates were slightly lower than anticipated; however, there is room to increase these based on information gathered and the support within the surgical community for a future trial. FUTURE WORK: Development of consensus regarding the population of interest for a trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12094890. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 62. See the NIHR Journals Library website for further project information.


Assuntos
Tratamento Conservador , Fraturas Ósseas , Adulto , Estudos de Viabilidade , Humanos , Inquéritos e Questionários , Avaliação da Tecnologia Biomédica
2.
Bone Joint J ; 103-B(11): 1717-1724, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34719266

RESUMO

AIMS: The main objective of this study was to examine whether the Oxford Shoulder Score (OSS) demonstrated floor or ceiling effects when used to measure outcomes following shoulder arthroplasty in a large national cohort. Secondary objectives were to assess its pain and function subscales, and to identify independent predictors for patients achieving a postoperative ceiling score following shoulder arthroplasty. METHODS: Secondary database analysis of the National Joint Registry (NJR), which included 48,270 patients undergoing shoulder arthroplasty, was conducted. The primary outcome measure was the OSS. Secondary outcome measures were the OSS-Function Component Subscale and OSS-Pain Component Subscale. Floor and ceiling effects were considered to be present if > 15% of patients scored either the lowest or highest possible score. Logistic regression analysis was used to identify independent predictors for scoring the highest possible OSS score postoperatively. RESULTS: Preoperatively, 1% of patients achieved the lowest possible OSS score (0) and 0.4% of patients achieved the highest possible score (48). Postoperatively, < 1% of patients achieved the lowest score at all timepoints, but the percentage achieving the highest score at six months was 8.3%, at three years 16.9%, and at five years 17%. Male patients, those aged between 60 and 89 years, and those undergoing an anatomical total shoulder arthroplasty (ATSA) were more likely to contribute to the ceiling effect seen in the OSS questionnaire. Pain and function subscales exhibited greater ceiling effects at three years and five years when compared with the overall OSS questionnaire. Logistic regression analysis showed that sex, procedure type, and preoperative OSS score were independent predictors for scoring the highest possible OSS at years. CONCLUSION: Based on NJR patient-reported outcome measures data, the OSS does not exhibit a ceiling effect at six months, but does at three years and five years, in part due to outcome scores of ATSA. Preoperative OSS, age, male sex, and ATSA are independent predictors of achieving a ceiling score. Cite this article: Bone Joint J 2021;103-B(11):1717-1724.


Assuntos
Artrite/cirurgia , Artroplastia do Ombro , Articulação do Ombro/lesões , Articulação do Ombro/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Autorrelato , Resultado do Tratamento , Reino Unido
4.
Shoulder Elbow ; 13(5): 469-470, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34659479
5.
Bone Jt Open ; 2(9): 773-784, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34555926

RESUMO

AIMS: This systematic review places a recently completed multicentre randomized controlled trial (RCT), UK FROST, in the context of existing randomized evidence for the management of primary frozen shoulder. UK FROST compared the effectiveness of pre-specified physiotherapy techniques with a steroid injection (PTSI), manipulation under anaesthesia (MUA) with a steroid injection, and arthroscopic capsular release (ACR). This review updates a 2012 review focusing on the effectiveness of MUA, ACR, hydrodilatation, and PTSI. METHODS: MEDLINE, Embase, PEDro, Science Citation Index, Clinicaltrials.gov, CENTRAL, and the World Health Organization (WHO) International Clinical Trials Registry were searched up to December 2018. Reference lists of included studies were screened. No language restrictions applied. Eligible studies were RCTs comparing the effectiveness of MUA, ACR, PTSI, and hydrodilatation against each other, or supportive care or no treatment, for the management of primary frozen shoulder. RESULTS: Nine RCTs were included. The primary outcome of patient-reported shoulder function at long-term follow-up (> 6 months and ≤ 12 months) was reported for five treatment comparisons across four studies. Standardized mean differences (SMD) were: ACR versus MUA: 0.21 (95% confidence interval (CI) 0.00 to 0.42), ACR versus supportive care: -0.13 (95% CI -1.10 to 0.83), and ACR versus PTSI: 0.33 (95% CI 0.07 to 0.59) and 0.25 (95% CI -0.34 to 0.85), all favouring ACR; MUA versus supportive care: 0 (95% CI -0.44 to 0.44) not favouring either; and MUA versus PTSI: 0.12 (95% CI -0.14 to 0.37) favouring MUA. None of these differences met the threshold of clinical significance agreed for the UK FROST and most confidence intervals included zero. CONCLUSION: The findings from a recent multicentre RCT provided the strongest evidence that, when compared with each other, neither PTSI, MUA, nor ACR are clinically superior. Evidence from smaller RCTs did not change this conclusion. The effectiveness of hydrodilatation based on four RCTs was inconclusive and there remains an evidence gap. Cite this article: Bone Jt Open 2021;2(9):773-784.

6.
Health Technol Assess ; 25(53): 1-52, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34505829

RESUMO

BACKGROUND: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. OBJECTIVES: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. DESIGN: To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. SETTING: A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. RESULTS: To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. CONCLUSIONS: The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. LIMITATIONS: Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. FUTURE WORK: Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. FUNDING: Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research programme.


Assuntos
Efeito Placebo , Humanos , Projetos de Pesquisa
7.
Clin Trials ; 18(6): 647-656, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34407641

RESUMO

BACKGROUND/AIMS: There is growing interest in the use of adaptive designs to improve the efficiency of clinical trials. We apply a Bayesian decision-theoretic model of a sequential experiment using cost and outcome data from the ProFHER pragmatic trial. We assess the model's potential for delivering value-based research. METHODS: Using parameter values estimated from the ProFHER pragmatic trial, including the costs of carrying out the trial, we establish when the trial could have stopped, had the model's value-based stopping rule been used. We use a bootstrap analysis and simulation study to assess a range of operating characteristics, which we compare with a fixed sample size design which does not allow for early stopping. RESULTS: We estimate that application of the model could have stopped the ProFHER trial early, reducing the sample size by about 14%, saving about 5% of the research budget and resulting in a technology recommendation which was the same as that of the trial. The bootstrap analysis suggests that the expected sample size would have been 38% lower, saving around 13% of the research budget, with a probability of 0.92 of making the same technology recommendation decision. It also shows a large degree of variability in the trial's sample size. CONCLUSIONS: Benefits to trial cost stewardship may be achieved by monitoring trial data as they accumulate and using a stopping rule which balances the benefit of obtaining more information through continued recruitment with the cost of obtaining that information. We present recommendations for further research investigating the application of value-based sequential designs.

8.
Bone Jt Open ; 2(8): 685-695, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34420365

RESUMO

AIMS: A pragmatic multicentre randomized controlled trial, UK FROzen Shoulder Trial (UK FROST), was conducted in the UK NHS comparing the cost-effectiveness of commonly used treatments for adults with primary frozen shoulder in secondary care. METHODS: A cost utility analysis from the NHS perspective was performed. Differences between manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR), and early structured physiotherapy plus steroid injection (ESP) in costs (2018 GBP price base) and quality adjusted life years (QALYs) at one year were used to estimate the cost-effectiveness of the treatments using regression methods. RESULTS: ACR was £1,734 more costly than ESP ((95% confidence intervals (CIs) £1,529 to £1,938)) and £1,457 more costly than MUA (95% CI £1,283 to £1,632). MUA was £276 (95% CI £66 to £487) more expensive than ESP. Overall, ACR had worse QALYs compared with MUA (-0.0293; 95% CI -0.0616 to 0.0030) and MUA had better QALYs compared with ESP (0.0396; 95% CI -0.0008 to 0.0800). At a £20,000 per QALY willingness-to-pay threshold, MUA had the highest probability of being cost-effective (0.8632) then ESP (0.1366) and ACR (0.0002). The results were robust to sensitivity analyses. CONCLUSION: While ESP was less costly, MUA was the most cost-effective option. ACR was not cost-effective. Cite this article: Bone Jt Open 2021;2(8):685-695.

9.
Pilot Feasibility Stud ; 7(1): 163, 2021 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-34416915

RESUMO

BACKGROUND: A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery. The use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh) have been used to produce patches. However, clinical evidence on their use is limited. The patch augmented rotator cuff surgery (PARCS) feasibility study aimed to determine the design of a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. METHODS: A mixed methods feasibility study of conducing a subsequent RCT. The project involved six stages: a systematic review of clinical evidence; a survey of the British Elbow and Shoulder Society's (BESS) surgical membership; a survey of surgeon trialists; focus groups and interviews with stakeholders; a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. RESULTS: The BESS surgeons' survey identified a variety of patches in use (105 (21%) responses received). Twenty-four surgeons (77%) completed the trialist survey relating to trial design. Four focus groups were conducted involving 24 stakeholders. Twenty-nine (67% of invited) individuals took part in the Delphi. Differing views were held on a number of aspects including the appropriate patient population for trial participation. Agreement on the key research questions and the outline of two potential RCTs were achieved through the Delphi study and the consensus meeting. CONCLUSIONS: Randomised comparisons of on-lay patch use for completed rotator cuff repairs, and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. The main limitation was that the findings were influenced by the participants, who might not necessarily reflect all stakeholders.

10.
Bone Joint J ; 103-B(7): 1277-1283, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34192942

RESUMO

AIMS: The aim of the Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) was to determine the optimal treatment for adults with a bicortical undisplaced or minimally displaced fracture of the waist of the scaphoid, comparing early surgical fixation with initial cast immobilization, with immediate fixation being offered to patients with nonunion. METHODS: A cost-effectiveness analysis was conducted to assess the relative merits of these forms of treatment. The differences in costs to the healthcare system and quality-adjusted life years (QALYs) of the patients over the one-year follow-up of the trial in the two treatment arms were estimated using regression analysis. RESULTS: Our base case analysis found that patients randomized to early surgical fixation had statistically significantly higher mean costs to the NHS of £1,295 more than for the cast immobilization arm (p < 0.001), primarily due to the cost of surgery. They also had a marginally better quality of life, over the period, of 0.0158 QALYs; however, this was not statistically significant (p = 0.379). The mean combined cost per additional QALY was £81,962, well above the accepted threshold for cost-effectiveness used in the UK and internationally. The probability of early surgery being cost-effective in this setting was only 5.6%. CONCLUSION: Consistent with the clinical findings of SWIFFT, these results indicate that initial cast immobilization of minimally displaced scaphoid fractures, with immediate fixation only offered to patients with nonunion, is the optimal form of treatment, resulting in comparable outcomes with less cost to the healthcare system. Cite this article: Bone Joint J 2021;103-B(7):1277-1283.


Assuntos
Moldes Cirúrgicos , Análise Custo-Benefício , Fixação de Fratura/economia , Fixação de Fratura/métodos , Fraturas Ósseas/terapia , Anos de Vida Ajustados por Qualidade de Vida , Osso Escafoide/lesões , Adulto , Idoso , Feminino , Fraturas Ósseas/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Reino Unido
11.
BMJ Open ; 11(6): e040829, 2021 06 11.
Artigo em Inglês | MEDLINE | ID: mdl-34117042

RESUMO

OBJECTIVES: To explore the experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST), a multicentre randomised controlled trial that compared manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR) with a 12-week early structured physiotherapy programme (ESP) in people with unilateral frozen shoulder referred to secondary care. DESIGN: Nested qualitative study with semistructured interviews. We used constant comparison method to develop our themes. SETTING: This qualitative study was nested within the UK FROST. PARTICIPANTS: 44 trial participants (ESP: 14; MUA: 15; ACR: 15), and 8 surgeons and 8 physiotherapists who delivered the treatments in the trial. RESULTS: Trial participants found UK FROST treatments acceptable and satisfactory in terms of content, delivery and treatment benefits. Participants in all arms experienced improvements in pain, shoulder movements, and function. Participants said they would choose the same treatment that they received in the trial.Surgeons and physiotherapists felt that the content and delivery of UK FROST treatments was not significantly different to their routine practice except for the additional number of physiotherapy sessions offered in the trial. They had mixed feelings about the effectiveness of UK FROST treatments. Both stressed the value of including hydrodilatation as a comparator of other treatment options. Physiotherapists raised concerns about the capacity to deliver the number of UK FROST physiotherapy sessions in routine clinical settings.Shared perceptions of trial participants, surgeons and physiotherapists were: (1) Pain relief and return of shoulder movements and function are important outcomes and (2) Adherence to exercises leads to better outcomes. CONCLUSION: In general, our findings indicated that trial participants, and surgeons and physiotherapists who delivered the treatments had positive experiences and perceptions in the UK FROST. Early qualitative investigations to explore the feasibility of delivering treatments in real-world settings are suggested in future trials in the frozen shoulder. TRIAL REGISTRATION NUMBER: International Standard Randomised Controlled Trial Register, ID: ISRCTN48804508. Registered on 25 July 2014; Results.


Assuntos
Bursite , Humanos , Percepção , Modalidades de Fisioterapia , Atenção Secundária à Saúde , Reino Unido
12.
J Clin Orthop Trauma ; 17: 254-260, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33936946

RESUMO

Symptomatic irreparable rotator cuff tears pose a challenge for shoulder surgeons. Whilst reverse polarity shoulder arthroplasty is an effective option for older symptomatic patients who have exhausted conservative management, the optimal treatment for younger patients remains controversial. In this article we outline the main tendon transfer options, including anatomical considerations, indications, contraindications, surgical technique, complications and a review of the evidence. Tendon transfers provide an alternative joint-preserving surgical option, but the evidence so far is limited, with a clear need for well-designed comparative studies to confirm their effectiveness.

13.
Shoulder Elbow ; 13(1): 5-11, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33747136

RESUMO

These care pathway guidelines for the shoulder have been written in collaboration with the NHS Evidence Based Interventions (EBI) programme. The EBI programme is a partnership between the Academy of Medical Royal Colleges, NHS Clinical Commissioners, the National Institute for Health and Care Excellence, as well as NHS England and Improvement.

14.
Health Technol Assess ; 25(13): 1-138, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33646096

RESUMO

BACKGROUND: A rotator cuff tear is a common, disabling shoulder problem. Symptoms may include pain, weakness, lack of shoulder mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a need to improve the outcome of rotator cuff surgery, and the use of patch augmentation (on-lay or bridging) to provide support to the healing process and improve patient outcomes holds promise. Patches have been made using different materials (e.g. human/animal skin or tissue and synthetic materials) and processes (e.g. woven or mesh). OBJECTIVES: The aim of the Patch Augmented Rotator Cuff Surgery (PARCS) feasibility study was to determine the design of a definitive randomised controlled trial assessing the clinical effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. DESIGN: A mixed-methods feasibility study of a randomised controlled trial. DATA SOURCES: MEDLINE, EMBASE and the Cochrane Library databases were searched between April 2006 and August 2018. METHODS: The project involved six stages: a systematic review of clinical evidence, a survey of the British Elbow and Shoulder Society's surgical membership, a survey of surgeon triallists, focus groups and interviews with stakeholders, a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. The various stakeholders (including patients, surgeons and industry representatives) were involved in stages 2-6. RESULTS: The systematic review comprised 52 studies; only 15 were comparative and, of these, 11 were observational (search conducted in August 2018). These studies were typically small (median number of participants 26, range 5-152 participants). There was some evidence to support the use of patches, although most comparative studies were at a serious risk of bias. Little to no published clinical evidence was available for a number of patches in clinical use. The membership survey of British Elbow and Shoulder surgeons [105 (21%) responses received] identified a variety of patches in use. Twenty-four surgeons (77%) completed the triallist survey relating to trial design. Four focus groups were conducted, involving 24 stakeholders. Differing views were held on a number of aspects of trial design, including the appropriate patient population (e.g. patient age) to participate. Agreement on the key research questions and the outline of two potential randomised controlled trials were achieved through the Delphi study [29 (67%)] and the consensus meeting that 22 participants attended. LIMITATIONS: The main limitation was that the findings were influenced by the participants, who are not necessarily representative of the views of the relevant stakeholder groups. CONCLUSION: The need for further clinical studies was clear, particularly given the range and number of different patches available. FUTURE WORK: Randomised comparisons of on-lay patch use for completed rotator cuff repairs and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. These elements are included in the trial designs proposed in this study. STUDY REGISTRATION: The systematic review is registered as PROSPERO CRD42017057908. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 13. See the NIHR Journals Library website for further project information.


Assuntos
Manguito Rotador , Animais , Análise Custo-Benefício , Estudos de Viabilidade , Humanos , Estudos Observacionais como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Manguito Rotador/cirurgia , Inquéritos e Questionários , Resultado do Tratamento
15.
Pilot Feasibility Stud ; 7(1): 17, 2021 Jan 07.
Artigo em Inglês | MEDLINE | ID: mdl-33413664

RESUMO

BACKGROUND: Clinically, a distinction is made between types of rotator cuff tear, traumatic and non-traumatic, and this sub-classification currently informs the treatment pathway. It is currently recommended that patients with traumatic rotator cuff tears are fast tracked for surgical opinion. However, there is uncertainty about the most clinically and cost-effective intervention for patients with traumatic rotator cuff tears and further research is required. SPeEDy will assess the feasibility of a fully powered, multi-centre randomised controlled trial (RCT) to test the hypothesis that, compared to surgical repair (and usual post-operative rehabilitation), a programme of physiotherapist-led exercise is not clinically inferior, but is more cost-effective for patients with traumatic rotator cuff tears. METHODS: SPeEDy is a two-arm, multi-centre pilot and feasibility RCT with integrated Quintet Recruitment Intervention (QRI) and further qualitative investigation of patient experience. A total of 76 patients with traumatic rotator cuff tears will be recruited from approximately eight UK NHS hospitals and randomly allocated to either surgical repair and usual post-operative rehabilitation or a programme of physiotherapist-led exercise. The QRI is a mixed-methods approach that includes data collection and analysis of screening logs, audio recordings of recruitment consultations, interviews with patients and clinicians involved in recruitment, and review of study documentation as a basis for developing action plans to address identified difficulties whilst recruitment to the RCT is underway. A further sample of patient participants will be purposively sampled from both intervention groups and interviewed to explore reasons for initial participation, treatment acceptability, reasons for non-completion of treatment, where relevant, and any reasons for treatment crossover. DISCUSSION: Research to date suggests that there is uncertainty regarding the most clinically and cost-effective interventions for patients with traumatic rotator cuff tears. There is a clear need for a high-quality, fully powered, RCT to better inform clinical practice. Prior to this, we first need to undertake a pilot and feasibility RCT to address current uncertainties about recruitment, retention and number of and reasons for treatment crossover. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT04027205 ) - Registered on 19 July 2019. Available via.

16.
Lancet ; 397(10272): 372-373, 2021 01 30.
Artigo em Inglês | MEDLINE | ID: mdl-33516337
17.
BMJ Open ; 10(12): e039552, 2020 12 07.
Artigo em Inglês | MEDLINE | ID: mdl-33293307

RESUMO

OBJECTIVE: To appraise studies reporting on clinical effectiveness and safety of surgical meshes used to augment rotator cuff repairs (RCRs). DESIGN: Systematic review and meta-analysis. DATA SOURCES: MEDLINE, Embase and Cochrane databases were searched between April 2006 and April 2020. ELIGIBILITY CRITERIA: All studies evaluating adults (≥18 years) undergoing RCR were considered. There were no language restrictions. DATA EXTRACTION AND SYNTHESIS: Screening, data extraction and quality appraisal were conducted by two independent reviewers. Meta-analysis was conducted using a random-effects models if ≥2 comparative studies reported the same outcome measure. Risk of bias assessment was undertaken for randomised (RoB2, Cochrane) and comparative studies (ROBINS-I, Cochrane). RESULTS: We included 60 studies, consisting of 7 randomised controlled trials, 13 observational comparative studies and 40 observational case series. All comparative studies reported on shoulder-specific functional outcome scores, 18 on the radiographic occurrence of re-tear and 14 on pain score metrics. All studies contained some risk of bias.Compared with non-augmented repair, a small improvement in shoulder-specific function or pain scores was observed for synthetic patches with a mean improvement of 6.7 points on the University of California Los Angles (UCLA) shoulder score (95% CI 0.1 to 13.4) and 0.46 point reduction on the Visual Analogue Scale (95% CI -0.74 to -0.17), respectively. A reduced likelihood of radiologically observed re-tear was observed for synthetic (risk ratio (RR) 0.41, 95% CI 0.27 to 0.61) and allograft (RR 0.34, 95% CI 0.18 to 0.65) patches. A total of 49 studies reported on the occurrence of complications. Slightly higher crude complication rates were observed following patch-augmented repair (2.1%) than standard repair (1.6%). CONCLUSIONS: While several studies suggest a decreased failure rate and small improvements in shoulder function and pain following augmented RCR, a paucity of rigorous clinical evaluation, for both effectiveness and safety, prevents firm recommendations. PROSPERO REGISTRATION NUMBER: CRD42017057908.


Assuntos
Lesões do Manguito Rotador , Manguito Rotador , Artroplastia , Humanos , Manguito Rotador/cirurgia , Lesões do Manguito Rotador/cirurgia , Ombro , Resultado do Tratamento
18.
Health Technol Assess ; 24(71): 1-162, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33292924

RESUMO

BACKGROUND: Frozen shoulder causes pain and stiffness. It affects around 10% of people in their fifties and is slightly more common in women. Costly and invasive surgical interventions are used, without high-quality evidence that these are effective. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of three treatments in secondary care for adults with frozen shoulder; to qualitatively explore the acceptability of these treatments to patients and health-care professionals; and to update a systematic review to explore the trial findings in the context of existing evidence for the three treatments. DESIGN: This was a pragmatic, parallel-group, multicentre, open-label, three-arm, randomised superiority trial with unequal allocation (2 : 2 : 1). An economic evaluation and a nested qualitative study were also carried out. SETTING: The orthopaedic departments of 35 hospitals across the UK were recruited from April 2015, with final follow-up in December 2018. PARTICIPANTS: Participants were adults (aged ≥ 18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation in the affected shoulder to < 50% of the opposite shoulder, and with plain radiographs excluding other pathology. INTERVENTIONS: The inventions were early structured physiotherapy with a steroid injection, manipulation under anaesthesia with a steroid injection and arthroscopic capsular release followed by manipulation. Both of the surgical interventions were followed with post-procedural physiotherapy. MAIN OUTCOME MEASURES: The primary outcome and end point was the Oxford Shoulder Score at 12 months post randomisation. A difference of 5 points between early structured physiotherapy and manipulation under anaesthesia or arthroscopic capsular release or of 4 points between manipulation under anaesthesia and arthroscopic capsular release was judged clinically important. RESULTS: The mean age of the 503 participants was 54 years; 319 were female (63%) and 150 had diabetes (30%). The primary analyses comprised 473 participants (94%). At the primary end point of 12 months, participants randomised to arthroscopic capsular release had, on average, a statistically significantly higher (better) Oxford Shoulder Score than those randomised to manipulation under anaesthesia (2.01 points, 95% confidence interval 0.10 to 3.91 points; p = 0.04) or early structured physiotherapy (3.06 points, 95% confidence interval 0.71 to 5.41 points; p = 0.01). Manipulation under anaesthesia did not result in statistically significantly better Oxford Shoulder Score than early structured physiotherapy (1.05 points, 95% confidence interval -1.28 to 3.39 points; p = 0.38). No differences were deemed of clinical importance. Serious adverse events were rare but occurred in participants randomised to surgery (arthroscopic capsular release,n = 8; manipulation under anaesthesia,n = 2). There was, however, one serious adverse event in a participant who received non-trial physiotherapy. The base-case economic analysis showed that manipulation under anaesthesia was more expensive than early structured physiotherapy, with slightly better utilities. The incremental cost-effectiveness ratio for manipulation under anaesthesia was £6984 per additional quality-adjusted life-year, and this intervention was probably 86% cost-effective at the threshold of £20,000 per quality-adjusted life-year. Arthroscopic capsular release was more costly than early structured physiotherapy and manipulation under anaesthesia, with no statistically significant benefit in utilities. Participants in the qualitative study wanted early medical help and a quicker pathway to resolve their shoulder problem. Nine studies were identified from the updated systematic review, including UK FROST, of which only two could be pooled, and found that arthroscopic capsular release was more effective than physiotherapy in the long-term shoulder functioning of patients, but not to the clinically important magnitude used in UK FROST. LIMITATIONS: Implementing physiotherapy to the trial standard in clinical practice might prove challenging but could avoid theatre use and post-procedural physiotherapy. There are potential confounding effects of waiting times in the trial. CONCLUSIONS: None of the three interventions was clearly superior. Early structured physiotherapy with a steroid injection is an accessible and low-cost option. Manipulation under anaesthesia is the most cost-effective option. Arthroscopic capsular release carries higher risks and higher costs. FUTURE WORK: Evaluation in a randomised controlled trial is recommended to address the increasing popularity of hydrodilatation despite the paucity of high-quality evidence. TRIAL REGISTRATION: Current Controlled Trials ISRCTN48804508. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 71. See the NIHR Journals Library website for further project information.


Assuntos
Bursite/terapia , Modalidades de Fisioterapia , Atenção Secundária à Saúde , Procedimentos Cirúrgicos Operatórios , Resultado do Tratamento , Adulto , Análise Custo-Benefício/economia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reino Unido
19.
Lancet ; 396(10256): 977-989, 2020 10 03.
Artigo em Inglês | MEDLINE | ID: mdl-33010843

RESUMO

BACKGROUND: Manipulation under anaesthesia and arthroscopic capsular release are costly and invasive treatments for frozen shoulder, but their effectiveness remains uncertain. We compared these two surgical interventions with early structured physiotherapy plus steroid injection. METHODS: In this multicentre, pragmatic, three-arm, superiority randomised trial, patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK. Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder. Participants were randomly assigned (2:2:1) to receive manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy. In manipulation under anaesthesia, the surgeon manipulated the affected shoulder to stretch and tear the tight capsule while the participant was under general anaesthesia, supplemented by a steroid injection. Arthroscopic capsular release, also done under general anaesthesia, involved surgically dividing the contracted anterior capsule in the rotator interval, followed by manipulation, with optional steroid injection. Both forms of surgery were followed by postprocedural physiotherapy. Early structured physiotherapy involved mobilisation techniques and a graduated home exercise programme supplemented by a steroid injection. Both early structured physiotherapy and postprocedural physiotherapy involved 12 sessions during up to 12 weeks. The primary outcome was the Oxford Shoulder Score (OSS; 0-48) at 12 months after randomisation, analysed by initial randomisation group. We sought a target difference of 5 OSS points between physiotherapy and either form of surgery, or 4 points between manipulation and capsular release. The trial registration is ISRCTN48804508. FINDINGS: Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55%) were randomly assigned. At 12 months, OSS data were available for 189 (94%) of 201 participants assigned to manipulation (mean estimate 38·3 points, 95% CI 36·9 to 39·7), 191 (94%) of 203 participants assigned to capsular release (40·3 points, 38·9 to 41·7), and 93 (94%) of 99 participants assigned to physiotherapy (37·2 points, 35·3 to 39·2). The mean group differences were 2·01 points (0·10 to 3·91) between the capsular release and manipulation groups, 3·06 points (0·71 to 5·41) between capsular release and physiotherapy, and 1·05 points (-1·28 to 3·39) between manipulation and physiotherapy. Eight serious adverse events were reported with capsular release and two with manipulation. At a willingness-to-pay threshold of £20 000 per quality-adjusted life-year, manipulation under anaesthesia had the highest probability of being cost-effective (0·8632, compared with 0·1366 for physiotherapy and 0·0002 for capsular release). INTERPRETATION: All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences. Therefore, none of the three interventions were clinically superior. Arthoscopic capsular release carried higher risks, and manipulation under anaesthesia was the most cost-effective. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Assuntos
Bursite/terapia , Glucocorticoides/administração & dosagem , Liberação da Cápsula Articular , Manipulação Ortopédica , Modalidades de Fisioterapia , Atenção Secundária à Saúde , Adulto , Feminino , Humanos , Injeções Intra-Articulares , Masculino , Pessoa de Meia-Idade , Amplitude de Movimento Articular , Resultado do Tratamento , Reino Unido
20.
Shoulder Elbow ; 12(5): 353-361, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33093874

RESUMO

Background: Total elbow arthroplasty (TEA) is the established treatment for end-stage rheumatoid arthritis but improved surgical techniques have resulted in expanded indications. The aim of this study is to review the literature to evaluate the evolution of surgical indications for TEA. Methods: A systematic review of PubMed and EMBASE databases was conducted. Case series and comparative studies reporting results after three types of primary TEA were eligible for inclusion. Results: Forty-nine eligible studies were identified (n = 1995). The number of TEA cases published annually increased from 6 cases in 1980 to 135 cases in 2008. The commonest indication for TEA throughout the review period was rheumatoid arthritis but its annual proportion reduced from 77% to 50%. The mean Mayo Elbow Performance Score significantly improved for all indications. Three comparative studies reported statistically improved functional outcomes in rheumatoid arthritis over the trauma sequelae group. Complication and revision rates varied; rheumatoid arthritis 5.2-30.9% and 11-13%, acute fracture 0-50% and 10-11%, trauma sequelae 14.2-50% and 0-30%, osteoarthritis 50% and 11%, respectively. Discussion: TEA can provide functional improvements in inflammatory arthritis, acute fractures, trauma sequelae and miscellaneous indications. Long-term TEA survivorship appears satisfactory in rheumatoid arthritis and fracture cases; however, further research into alternative surgical indications is still required.

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