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Bone & Joint Open
Vol. 4, Issue 4 | Pages 226 - 233
1 Apr 2023
Moore AJ Wylde V Whitehouse MR Beswick AD Walsh NE Jameson C Blom AW

Aims. Periprosthetic hip-joint infection is a multifaceted and highly detrimental outcome for patients and clinicians. The incidence of prosthetic joint infection reported within two years of primary hip arthroplasty ranges from 0.8% to 2.1%. Costs of treatment are over five-times greater in people with periprosthetic hip joint infection than in those with no infection. Currently, there are no national evidence-based guidelines for treatment and management of this condition to guide clinical practice or to inform clinical study design. The aim of this study is to develop guidelines based on evidence from the six-year INFection and ORthopaedic Management (INFORM) research programme. Methods. We used a consensus process consisting of an evidence review to generate items for the guidelines and online consensus questionnaire and virtual face-to-face consensus meeting to draft the guidelines. Results. The consensus panel comprised 21 clinical experts in orthopaedics, primary care, rehabilitation, and healthcare commissioning. The final output from the consensus process was a 14-item guideline. The guidelines make recommendations regarding increased vigilance and monitoring of those at increased risk of infection; diagnosis including strategies to ensure the early recognition of prosthetic infection and referral to orthopaedic teams; treatment, including early use of DAIR and revision strategies; and postoperative management including appropriate physical and psychological support and antibiotic strategies. Conclusion. We believe the implementation of the INFORM guidelines will inform treatment protocols and clinical pathways to improve the treatment and management of periprosthetic hip infection. Cite this article: Bone Jt Open 2023;4(4):226–233


Bone & Joint Open
Vol. 4, Issue 2 | Pages 72 - 78
9 Feb 2023
Kingsbury SR Smith LKK Pinedo-Villanueva R Judge A West R Wright JM Stone MH Conaghan PG

Aims

To review the evidence and reach consensus on recommendations for follow-up after total hip and knee arthroplasty.

Methods

A programme of work was conducted, including: a systematic review of the clinical and cost-effectiveness literature; analysis of routine national datasets to identify pre-, peri-, and postoperative predictors of mid-to-late term revision; prospective data analyses from 560 patients to understand how patients present for revision surgery; qualitative interviews with NHS managers and orthopaedic surgeons; and health economic modelling. Finally, a consensus meeting considered all the work and agreed the final recommendations and research areas.


Bone & Joint Open
Vol. 4, Issue 9 | Pages 696 - 703
11 Sep 2023
Ormond MJ Clement ND Harder BG Farrow L Glester A

Aims. The principles of evidence-based medicine (EBM) are the foundation of modern medical practice. Surgeons are familiar with the commonly used statistical techniques to test hypotheses, summarize findings, and provide answers within a specified range of probability. Based on this knowledge, they are able to critically evaluate research before deciding whether or not to adopt the findings into practice. Recently, there has been an increased use of artificial intelligence (AI) to analyze information and derive findings in orthopaedic research. These techniques use a set of statistical tools that are increasingly complex and may be unfamiliar to the orthopaedic surgeon. It is unclear if this shift towards less familiar techniques is widely accepted in the orthopaedic community. This study aimed to provide an exploration of understanding and acceptance of AI use in research among orthopaedic surgeons. Methods. Semi-structured in-depth interviews were carried out on a sample of 12 orthopaedic surgeons. Inductive thematic analysis was used to identify key themes. Results. The four intersecting themes identified were: 1) validity in traditional research, 2) confusion around the definition of AI, 3) an inability to validate AI research, and 4) cautious optimism about AI research. Underpinning these themes is the notion of a validity heuristic that is strongly rooted in traditional research teaching and embedded in medical and surgical training. Conclusion. Research involving AI sometimes challenges the accepted traditional evidence-based framework. This can give rise to confusion among orthopaedic surgeons, who may be unable to confidently validate findings. In our study, the impact of this was mediated by cautious optimism based on an ingrained validity heuristic that orthopaedic surgeons develop through their medical training. Adding to this, the integration of AI into everyday life works to reduce suspicion and aid acceptance. Cite this article: Bone Jt Open 2023;4(9):696–703


Bone & Joint Open
Vol. 3, Issue 3 | Pages 245 - 251
16 Mar 2022
Lester D Barber C Sowers CB Cyrus JW Vap AR Golladay GJ Patel NK

Aims. Return to sport following undergoing total (TKA) and unicompartmental knee arthroplasty (UKA) has been researched with meta-analyses and systematic reviews of varying quality. The aim of this study is to create an umbrella review to consolidate the data into consensus guidelines for returning to sports following TKA and UKA. Methods. Systematic reviews and meta-analyses written between 2010 and 2020 were systematically searched. Studies were independently screened by two reviewers and methodology quality was assessed. Variables for analysis included objective classification of which sports are safe to participate in postoperatively, time to return to sport, prognostic indicators of returning, and reasons patients do not. Results. A total of 410 articles were found, including 58 duplicates. Seven articles meeting inclusion criteria reported that 34% to 100% of patients who underwent TKA or UKA were able to return to sports at 13 weeks and 12 weeks respectively, with UKA patients more likely to do so. Prior experience with the sport was the most significant prognostic indicator for return. These patients were likely to participate in low-impact sports, particularly walking, cycling, golf, and swimming. Moderate-impact sport participation, such as doubles tennis and skiing, may be considered on a case-by-case basis considering the patient’s prior experience. There is insufficient long-term data on the risks to return to high-impact sport, such as decreased implant survivorship. Conclusion. There is a consensus that patients can return to low-impact sports following TKA or UKA. Return to moderate-impact sport was dependent on a case-by-case basis, with emphasis on the patient’s prior experience in the sport. Return to high-impact sports was not supported. Patients undergoing UKA return to sport one week sooner and with more success than TKA. Future studies are needed to assess long-term outcomes following return to high-impact sports to establish evidence-based recommendations. This review summarizes all available data for the most up-to-date and evidence-based guidelines for returning to sport following TKA and UKA to replace guidelines based on subjective physician survey data. Cite this article: Bone Jt Open 2022;3(3):245–251


Bone & Joint Open
Vol. 2, Issue 5 | Pages 344 - 350
31 May 2021
Ahmad SS Hoos L Perka C Stöckle U Braun KF Konrads C

Aims. The follow-up interval of a study represents an important aspect that is frequently mentioned in the title of the manuscript. Authors arbitrarily define whether the follow-up of their study is short-, mid-, or long-term. There is no clear consensus in that regard and definitions show a large range of variation. It was therefore the aim of this study to systematically identify clinical research published in high-impact orthopaedic journals in the last five years and extract follow-up information to deduce corresponding evidence-based definitions of short-, mid-, and long-term follow-up. Methods. A systematic literature search was performed to identify papers published in the six highest ranked orthopaedic journals during the years 2015 to 2019. Follow-up intervals were analyzed. Each article was assigned to a corresponding subspecialty field: sports traumatology, knee arthroplasty and reconstruction, hip-preserving surgery, hip arthroplasty, shoulder and elbow arthroplasty, hand and wrist, foot and ankle, paediatric orthopaedics, orthopaedic trauma, spine, and tumour. Mean follow-up data were tabulated for the corresponding subspecialty fields. Comparison between means was conducted using analysis of variance. Results. Of 16,161 published articles, 590 met the inclusion criteria. Of these, 321 were of level IV evidence, 176 level III, 53 level II, and 40 level I. Considering all included articles, a long-term study published in the included high impact journals had a mean follow-up of 151.6 months, a mid-term study of 63.5 months, and a short-term study of 30.0 months. Conclusion. The results of this study provide evidence-based definitions for orthopaedic follow-up intervals that should provide a citable standard for the planning of clinical studies. A minimum mean follow-up of a short-term study should be 30 months (2.5 years), while a mid-term study should aim for a mean follow-up of 60 months (five years), and a long-term study should aim for a mean of 150 months (12.5 years). Level of Evidence: Level I. Cite this article: Bone Jt Open 2021;2(5):344–350


Bone & Joint Open
Vol. 2, Issue 2 | Pages 93 - 102
1 Feb 2021
Thompson JW Wignadasan W Ibrahim M Beasley L Konan S Plastow R Magan A Haddad FS

Aims. We present the development of a day-case total hip arthroplasty (THA) pathway in a UK National Health Service institution in conjunction with an extensive evidence-based summary of the interventions used to achieve successful day-case THA to which the protocol is founded upon. Methods. We performed a prospective audit of day-case THA in our institution as we reinitiate our full capacity elective services. In parallel, we performed a review of the literature reporting complication or readmission rates at ≥ 30-day postoperative following day-case THA. Electronic searches were performed using four databases from the date of inception to November 2020. Relevant studies were identified, data extracted, and qualitative synthesis performed. Results. Our evaluation and critique of the evidence-based literature identifies day-case THA to be safe, effective, and economical, benefiting both patients and healthcare systems alike. We further validate this with our institutional elective day surgery arthroplasty pathway (EDSAP) and report a small cohort of successful day-case THA cases as an example in the early stages of this practice in our unit. Conclusion. Careful patient selection and education, adequate perioperative considerations, including multimodal analgesia, surgical technique and blood loss management protocols and appropriate postoperative pathways comprising reliable discharge criteria are essential for successful day-case THA. Cite this article: Bone Jt Open 2021;2(2):93–102


Bone & Joint Open
Vol. 1, Issue 10 | Pages 644 - 653
14 Oct 2020
Kjærvik C Stensland E Byhring HS Gjertsen J Dybvik E Søreide O

Aims. The aim of this study was to describe variation in hip fracture treatment in Norway expressed as adherence to international and national evidence-based treatment guidelines, to study factors influencing deviation from guidelines, and to analyze consequences of non-adherence. Methods. International and national guidelines were identified and treatment recommendations extracted. All 43 hospitals routinely treating hip fractures in Norway were characterized. From the Norwegian Hip Fracture Register (NHFR), hip fracture patients aged > 65 years and operated in the period January 2014 to December 2018 for fractures with conclusive treatment guidelines were included (n = 29,613: femoral neck fractures (n = 21,325), stable trochanteric fractures (n = 5,546), inter- and subtrochanteric fractures (n = 2,742)). Adherence to treatment recommendations and a composite indicator of best practice were analyzed. Patient survival and reoperations were evaluated for each recommendation. Results. Median age of the patients was 84 (IQR 77 to 89) years and 69% (20,427/29,613) were women. Overall, 79% (23,390/29,613) were treated within 48 hours, and 80% (23,635/29,613) by a surgeon with more than three years’ experience. Adherence to guidelines varied substantially but was markedly better in 2018 than in 2014. Having a dedicated hip fracture unit (OR 1.06, 95%CI 1.01 to 1.11) and a hospital hip fracture programme (OR 1.16, 95% CI 1.06 to 1.27) increased the probability of treatment according to best practice. Surgery after 48 hours increased one-year mortality significantly (OR 1.13, 95% CI 1.05 to 1.22; p = 0.001). Alternative treatment to arthroplasty for displaced femoral neck fractures (FNFs) increased mortality after 30 days (OR 1.29, 95% CI 1.03 to 1.62)) and one year (OR 1.45, 95% CI 1.22 to 1.72), and also increased the number of reoperations (OR 4.61, 95% CI 3.73 to 5.71). An uncemented stem increased the risk of reoperation significantly (OR 1.23, 95% CI 1.02 to 1.48; p = 0.030). Conclusion. Our study demonstrates a substantial variation between hospitals in adherence to evidence-based guidelines for treatment of hip fractures in Norway. Non-adherence can be ascribed to in-hospital factors. Poor adherence has significant negative consequences for patients in the form of increased mortality rates at 30 and 365 days post-treatment and in reoperation rates. Cite this article: Bone Joint Open 2020;1-10:644–653


Bone & Joint Open
Vol. 2, Issue 3 | Pages 141 - 149
1 Mar 2021
Saab M Chick G

Aims. The objective of this systematic review was to describe trapeziectomy outcomes and complications in the context of osteoarthritis of the base of the thumb after a five-year minimum follow-up. Methods. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used to guide study design, and 267 full-text articles were assessed for eligibility. After exclusion criteria application, 22 studies were included, involving 728 patients and 823 trapeziectomies. Outcomes included pre- and postoperative clinical and radiological characteristics. Complications and revisions were recorded. Results. All the studies reported good results regarding pain and range of motion at the last follow-up of 8.3 years (5 to 22); the mean satisfaction rate was 91% (84% to 100%). It was difficult to assess the impact on metacarpophalangeal joint motion in extension with contrary results. The key pinch returned to its preoperative values, whereas tip pinch showed a modest improvement (+14%), with a mild improvement found in grip strength (+25%) at the last follow-up. The mean progressive trapezial collapse was 48% (0% to 85%) and was not correlated with pain, grip strength, or satisfaction. The most represented complications were linked to tendons or nerves affected during additional procedures to stabilize the joint (11.6%; n = 56). Mechanical complications included symptomatic scapho-M1 impingement (3.1%; n = 15/580), leading to nine surgical revisions out of 581 trapeziectomies. Meta-analysis was not possible due to study heterogeneity and limited data. Conclusion. After a minimum five-year follow-up, trapeziectomy achieved high patient satisfaction and pain relief. However, strength seemed to be deteriorating with detrimental consequences, but this did not correlate with trapezial collapse. The issues related to underestimating mechanical complications and varying degrees of success should be highlighted in the information given to patients. Evidence-based analyses should help the surgeon in their decision-making. Cite this article: Bone Jt Open 2021;2(3):141–149


Bone & Joint Open
Vol. 2, Issue 10 | Pages 806 - 812
1 Oct 2021
Gerritsen M Khawar A Scheper H van der Wal R Schoones J de Boer M Nelissen R Pijls B

Aims. The aim of this meta-analysis is to assess the association between exchange of modular parts in debridement, antibiotics, and implant retention (DAIR) procedure and outcomes for hip and knee periprosthetic joint infection (PJI). Methods. We conducted a systematic search on PubMed, Embase, Web of Science, and Cochrane library from inception until May 2021. Random effects meta-analyses and meta-regression was used to estimate, on a study level, the success rate of DAIR related to component exchange. Risk of bias was appraised using the (AQUILA) checklist. Results. We included 65 studies comprising 6,630 patients. The pooled overall success after DAIR for PJI was 67% (95% confidence interval (CI) 63% to 70%). This was 70% (95% CI 65% to 75%) for DAIR for hip PJI and 63% (95% CI 58% to 69%) for knee PJI. In studies before 2004 (n = 27), our meta-regression analysis showed a 3.5% increase in success rates for each 10% increase in component exchange in DAIR for hip PJI and a 3.1% increase for each 10% increase in component exchange for knee PJI. When restricted to studies after 2004 (n = 37), this association changed: for DAIR for hip PJI a decrease in successful outcome by 0.5% for each 10% increase in component exchange and for DAIR for knee PJI this was a 0.01% increase in successful outcome for each 10% increase in component exchange. Conclusion. This systematic review and meta-regression found no benefit of modular component exchange on reduction of PJI failure. This limited effect should be weighed against the risks for the patient and cost on a case-by-case basis. The association between exchange of modular components and outcome changed before and after 2004. This suggests the effect seen after 2004 may reflect a more rigorous, evidence-based, approach to the infected implant compared to the years before. Level of Evidence: Level III. Cite this article: Bone Jt Open 2021;2(10):806–812


Bone & Joint Open
Vol. 5, Issue 6 | Pages 499 - 513
20 Jun 2024
Keene DJ Achten J Forde C Png ME Grant R Draper K Appelbe D Tutton E Peckham N Dutton SJ Lamb SE Costa ML

Aims

Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures.

Methods

This will be a multicentre, parallel-group, individually randomized controlled superiority trial. We aim to recruit 344 participants aged 50 years and older with an ankle fracture treated surgically or non-surgically from at least 20 NHS hospitals. Participants will be randomized 1:1 using a web-based service to supervised rehabilitation (four to six one-to-one physiotherapy sessions of tailored advice and prescribed home exercise over three months), or self-directed rehabilitation (provision of advice and exercise materials that participants will use to manage their recovery independently). The primary outcome is participant-reported ankle-related symptoms and function six months after randomization, measured by the Olerud and Molander Ankle Score. Secondary outcomes at two, four, and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, complications, and resource use. Due to the nature of the interventions, participants and intervention providers will be unblinded to treatment allocation.


Bone & Joint Open
Vol. 5, Issue 2 | Pages 94 - 100
5 Feb 2024
Mancino F Kayani B Gabr A Fontalis A Plastow R Haddad FS

Anterior cruciate ligament (ACL) injuries are among the most common and debilitating knee injuries in professional athletes with an incidence in females up to eight-times higher than their male counterparts. ACL injuries can be career-threatening and are associated with increased risk of developing knee osteoarthritis in future life. The increased risk of ACL injury in females has been attributed to various anatomical, developmental, neuromuscular, and hormonal factors. Anatomical and hormonal factors have been identified and investigated as significant contributors including osseous anatomy, ligament laxity, and hamstring muscular recruitment. Postural stability and impact absorption are associated with the stabilizing effort and stress on the ACL during sport activity, increasing the risk of noncontact pivot injury. Female patients have smaller diameter hamstring autografts than males, which may predispose to increased risk of re-rupture following ACL reconstruction and to an increased risk of chondral and meniscal injuries. The addition of an extra-articular tenodesis can reduce the risk of failure; therefore, it should routinely be considered in young elite athletes. Prevention programs target key aspects of training including plyometrics, strengthening, balance, endurance and stability, and neuromuscular training, reducing the risk of ACL injuries in female athletes by up to 90%. Sex disparities in access to training facilities may also play an important role in the risk of ACL injuries between males and females. Similarly, football boots, pitches quality, and football size and weight should be considered and tailored around females’ characteristics. Finally, high levels of personal and sport-related stress have been shown to increase the risk of ACL injury which may be related to alterations in attention and coordination, together with increased muscular tension, and compromise the return to sport after ACL injury. Further investigations are still necessary to better understand and address the risk factors involved in ACL injuries in female athletes.

Cite this article: Bone Jt Open 2024;5(2):94–100.


Bone & Joint Open
Vol. 4, Issue 10 | Pages 742 - 749
6 Oct 2023
Mabrouk A Abouharb A Stewart G Palan J Pandit H

Aims

Prophylactic antibiotic regimens for elective primary total hip and knee arthroplasty vary widely across hospitals and trusts in the UK. This study aimed to identify antibiotic prophylaxis regimens currently in use for elective primary arthroplasty across the UK, establish variations in antibiotic prophylaxis regimens and their impact on the risk of periprosthetic joint infection (PJI) in the first-year post-index procedure, and evaluate adherence to current international consensus guidance.

Methods

The guidelines for the primary and alternative recommended prophylactic antibiotic regimens in clean orthopaedic surgery (primary arthroplasty) for 109 hospitals and trusts across the UK were sought by searching each trust and hospital’s website (intranet webpages), and by using the MicroGuide app. The mean cost of each antibiotic regimen was calculated using price data from the British National Formulary (BNF). Regimens were then compared to the 2018 Philadelphia Consensus Guidance, to evaluate adherence to international guidance.


Bone & Joint Open
Vol. 3, Issue 10 | Pages 832 - 840
24 Oct 2022
Pearson NA Tutton E Joeris A Gwilym SE Grant R Keene DJ Haywood KL

Aims

To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures.

Methods

Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed.


Bone & Joint Open
Vol. 3, Issue 12 | Pages 924 - 932
23 Dec 2022
Bourget-Murray J Horton I Morris J Bureau A Garceau S Abdelbary H Grammatopoulos G

Aims

The aims of this study were to determine the incidence and factors for developing periprosthetic joint infection (PJI) following hemiarthroplasty (HA) for hip fracture, and to evaluate treatment outcome and identify factors associated with treatment outcome.

Methods

A retrospective review was performed of consecutive patients treated for HA PJI at a tertiary referral centre with a mean 4.5 years’ follow-up (1.6 weeks to 12.9 years). Surgeries performed included debridement, antibiotics, and implant retention (DAIR) and single-stage revision. The effect of different factors on developing infection and treatment outcome was determined.


Bone & Joint Open
Vol. 3, Issue 10 | Pages 741 - 745
1 Oct 2022
Baldock TE Dixon JR Koubaesh C Johansen A Eardley WGP

Aims

Patients with A1 and A2 trochanteric hip fractures represent a substantial proportion of trauma caseload, and national guidelines recommend that sliding hip screws (SHS) should be used for these injuries. Despite this, intramedullary nails (IMNs) are routinely implanted in many hospitals, at extra cost and with unproven patient outcome benefit. We have used data from the National Hip Fracture Database (NHFD) to examine the use of SHS and IMN for A1 and A2 hip fractures at a national level, and to define the cost implications of management decisions that run counter to national guidelines.

Methods

We used the NHFD to identify all operations for fixation of trochanteric fractures in England and Wales between 1 January 2021 and 31 December 2021. A uniform price band from each of three hip fracture implant manufacturers was used to set cost implications alongside variation in implant use.


Bone & Joint Open
Vol. 3, Issue 10 | Pages 753 - 758
4 Oct 2022
Farrow L Clement ND Smith D Meek DRM Ryan M Gillies K Anderson L Ashcroft GP

Aims

The extended wait that most patients are now experiencing for hip and knee arthroplasty has raised questions about whether reliance on waiting time as the primary driver for prioritization is ethical, and if other additional factors should be included in determining surgical priority. Our Prioritization of THose aWaiting hip and knee ArthroplastY (PATHWAY) project will explore which perioperative factors are important to consider when prioritizing those on the waiting list for hip and knee arthroplasty, and how these factors should be weighted. The final product will include a weighted benefit score that can be used to aid in surgical prioritization for those awaiting elective primary hip and knee arthroplasty.

Methods

There will be two linked work packages focusing on opinion from key stakeholders (patients and surgeons). First, an online modified Delphi process to determine a consensus set of factors that should be involved in patient prioritization. This will be performed using standard Delphi methodology consisting of multiple rounds where following initial individual rating there is feedback, discussion, and further recommendations undertaken towards eventual consensus. The second stage will then consist of a Discrete Choice Experiment (DCE) to allow for priority setting of the factors derived from the Delphi through elicitation of weighted benefit scores. The DCE consists of several choice tasks designed to elicit stakeholder preference regarding included attributes (factors).


Bone & Joint Open
Vol. 4, Issue 7 | Pages 490 - 495
4 Jul 2023
Robinson PG Creighton AP Cheng J Dines JS Su EP Gulotta LV Padgett D Demetracopoulos C Hawkes R Prather H Press JM Clement ND

Aims

The primary aim of this prospective, multicentre study is to describe the rates of returning to golf following hip, knee, ankle, and shoulder arthroplasty in an active golfing population. Secondary aims will include determining the timing of return to golf, changes in ability, handicap, and mobility, and assessing joint-specific and health-related outcomes following surgery.

Methods

This is a multicentre, prospective, longitudinal study between the Hospital for Special Surgery, (New York City, New York, USA) and Edinburgh Orthopaedics, Royal Infirmary of Edinburgh, (Edinburgh, UK). Both centres are high-volume arthroplasty centres, specializing in upper and lower limb arthroplasty. Patients undergoing hip, knee, ankle, or shoulder arthroplasty at either centre, and who report being golfers prior to arthroplasty, will be included. Patient-reported outcome measures will be obtained at six weeks, three months, six months, and 12 months. A two-year period of recruitment will be undertaken of arthroplasty patients at both sites.


Bone & Joint Open
Vol. 4, Issue 5 | Pages 378 - 384
23 May 2023
Jones CS Eardley WGP Johansen A Inman DS Evans JT

Aims

The aim of this study was to describe services available to patients with periprosthetic femoral fracture (PPFF) in England and Wales, with focus on variation between centres and areas for care improvement.

Methods

This work used data freely available from the National Hip Fracture Database (NHFD) facilities survey in 2021, which asked 21 questions about the care of patients with PPFFs, and nine relating to clinical decision-making around a hypothetical case.


Bone & Joint Open
Vol. 4, Issue 8 | Pages 573 - 579
8 Aug 2023
Beresford-Cleary NJA Silman A Thakar C Gardner A Harding I Cooper C Cook J Rothenfluh DA

Aims

Symptomatic spinal stenosis is a very common problem, and decompression surgery has been shown to be superior to nonoperative treatment in selected patient groups. However, performing an instrumented fusion in addition to decompression may avoid revision and improve outcomes. The aim of the SpInOuT feasibility study was to establish whether a definitive randomized controlled trial (RCT) that accounted for the spectrum of pathology contributing to spinal stenosis, including pelvic incidence-lumbar lordosis (PI-LL) mismatch and mobile spondylolisthesis, could be conducted.

Methods

As part of the SpInOuT-F study, a pilot randomized trial was carried out across five NHS hospitals. Patients were randomized to either spinal decompression alone or spinal decompression plus instrumented fusion. Patient-reported outcome measures were collected at baseline and three months. The intended sample size was 60 patients.


Bone & Joint Open
Vol. 5, Issue 9 | Pages 729 - 735
3 Sep 2024
Charalambous CP Hirst JT Kwaees T Lane S Taylor C Solanki N Maley A Taylor R Howell L Nyangoma S Martin FL Khan M Choudhry MN Shetty V Malik RA

Aims

Steroid injections are used for subacromial pain syndrome and can be administered via the anterolateral or posterior approach to the subacromial space. It is not currently known which approach is superior in terms of improving clinical symptoms and function. This is the protocol for a randomized controlled trial (RCT) to compare the clinical effectiveness of a steroid injection given via the anterolateral or the posterior approach to the subacromial space.

Methods

The Subacromial Approach Injection Trial (SAInT) study is a single-centre, parallel, two-arm RCT. Participants will be allocated on a 1:1 basis to a subacromial steroid injection via either the anterolateral or the posterior approach to the subacromial space. Participants in both trial arms will then receive physiotherapy as standard of care for subacromial pain syndrome. The primary analysis will compare the change in Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include the change in OSS at six and 12 months, as well as the Pain Numeric Rating Scale (0 = no pain, 10 = worst pain), Disabilities of Arm, Shoulder and Hand questionnaire (DASH), and 36-Item Short-Form Health Survey (SF-36) (RAND) at three months, six months, and one year after injection. Assessment of pain experienced during the injection will also be determined. A minimum of 86 patients will be recruited to obtain an 80% power to detect a minimally important difference of six points on the OSS change between the groups at three months after injection.