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    Impact of Frailty on the Development of Proximal Junctional Failure: Does Frailty Supersede Achieving Optimal Realignment?
    (Wolters Kluwer, 2023-05-01) Krol, O.; McFarland, K.; Owusu-Sarpong, S.; Sagoo, N.; Williamson, T.; Joujon-Roche, R.; Tretiakov, P.; Imbo, B.; Dave, P.; Mir, J.; Lebovic, J.; Onafowokan, O. O.; Schoenfeld, A. J.; De la Garza Ramos, R.; Janjua, M. B.; Sciubba, D. M.; Diebo, B. G.; Vira, S.; Smith, J. S.; Lafage, V.; Lafage, R.; Passias, P. G.
    BACKGROUND: Patients undergoing surgery for adult spinal deformity (ASD) are often elderly, frail, and at elevated risk of adverse events perioperatively, with proximal junctional failure (PJF) occurring relatively frequently. Currently, the specific role of frailty in potentiating this outcome is poorly defined. PURPOSE: To determine if the benefits of optimal realignment in ASD, with respect to the development of PJF, can be offset by increasing frailty. STUDY DESIGN: Retrospective cohort. METHODS: Operative ASD patients (scoliosis >20°, SVA>5 cm, PT>25°, or TK>60°) fused to pelvis or below with available baseline (BL) and 2-year (2Y) radiographic and HRQL data were included. The Miller Frailty Index (FI) was used to stratify patients into 2 categories: Not Frail (FI <3) and Frail (>3). Proximal Junctional Failure (PJF) was defined using the Lafage criteria. Matched" and "unmatched" refers to ideal age-adjusted alignment post-operatively. Multivariable regression determined impact of frailty on development of PJF. RESULTS: 284 ASD patients met inclusion criteria (62.2yrs±9.9, 81%F, BMI: 27.5 kg/m2±5.3, ASD-FI: 3.4±1.5, CCI: 1.7±1.6). 43% of patients were characterized as Not Frail (NF) and 57% were characterized as Frail (F). PJF development was lower in the NF group compared to the F group, (7% vs. 18%; P=0.002). F patients had 3.2X higher risk of PJF development compared to NF patients (OR: 3.2, 95% CI: 1.3-7.3, P=0.009). Controlling for baseline factors, F unmatched patients had a higher degree of PJF (OR: 1.4, 95% CI:1.02-1.8, P=0.03), however, with prophylaxis there was no increased risk. Adjusted analysis shows F patients when matched post-operatively in PI-LL had no significantly higher risk of PJF. CONCLUSIONS: An increasingly frail state is significantly associated with the development of PJF after corrective surgery for ASD. Optimal realignment may mitigate the impact of frailty on eventual PJF. Prophylaxis should be considered in frail patients who do not reach ideal alignment goals."
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    Better post-operative prediction and management of chronic pain in adults after total knee replacement: the multidisciplinary STAR research programme including RCT
    (NIHR Journals Library, 2023-06-01) Gooberman-Hill, R.; Wylde, V.; Bertram, W.; Moore, A. J.; Pinedo-Villanueva, R.; Sanderson, E.; Dennis, J.; Harris, S.; Judge, A.; Noble, S.; Beswick, A. D.; Burston, A.; Peters, T. J.; Bruce, J.; Eccleston, C.; Long, S.; Walsh, D.; Howells, N.; White, S.; Price, A.; Arden, N.; Toms, A.; McCabe, C.; Blom, A. W.
    BACKGROUND: The treatment of osteoarthritis with knee replacement aims to reduce pain and disability. However, some people experience chronic pain. OBJECTIVES: To improve outcomes for people with chronic pain after knee replacement by identifying post-surgical predictors and effective interventions, characterising patient pathways and resource use, developing and evaluating a new care pathway, and exploring non-use of services. DESIGN: The programme comprised systematic reviews, national database analyses, a cohort study, intervention development, a randomised controlled trial, health economic analyses, qualitative studies and stakeholder engagement. Extensive and meaningful patient and public involvement underpinned all studies. SETTING: NHS, secondary care, primary care. PARTICIPANTS: People with, or at risk of, chronic pain after knee replacement and health-care professionals involved in the care of people with pain. INTERVENTIONS: A care pathway for the management of people with pain at 3 months after knee replacement. MAIN OUTCOME MEASURES: Patient-reported outcomes and cost-effectiveness over 12 months. DATA SOURCES: Literature databases, the National Joint Registry, Hospital Episode Statistics, patient-reported outcomes, the Clinical Practice Research Datalink, the Clinical Outcomes in Arthroplasty Study, the Support and Treatment After joint Replacement randomised trial, interviews with 90 patients and 14 health-care professionals, and stakeholder events. REVIEW METHODS: Systematic reviews of cohort studies or randomised trials, using meta-analysis or narrative synthesis. RESULTS: In the Clinical Outcomes in Arthroplasty Study cohort, 14% of people experienced chronic pain 1 year after knee replacement. By 5 years, 65% reported no pain, 31% fluctuated and 4% remained in chronic pain. People with chronic pain had a worse quality of life, higher primary care costs, and more frequent analgesia prescriptions, particularly for opioids, than those not in chronic pain. People with chronic pain after knee replacement who made little or no use of services often felt nothing more could be done, or that further treatments may have no benefit or cause harm. People described a feeling of disconnection from their replaced knee. Analysis of UK databases identified risk factors for chronic pain after knee replacement. Pre-operative predictors were mild knee pain, smoking, deprivation, body mass index between 35 and 40 kg/m(2) and knee arthroscopy. Peri- and post-operative predictors were mechanical complications, infection, readmission, revision, extended hospital stay, manipulation under anaesthetic and use of opioids or antidepressants. In systematic reviews, pre-operative exercise and education showed no benefit in relation to chronic pain. Peri-operative interventions that merit further research were identified. Common peri-operative treatments were not associated with chronic pain. There was no strong evidence favouring specific post-operative physiotherapy content. We evaluated the Support and Treatment After joint Replacement care pathway in a multicentre randomised controlled trial. We randomised 363 people with pain at 3 months after knee replacement from eight NHS Trusts in England and Wales. At 12 months’ follow-up, the intervention group had lower mean pain severity (adjusted difference –0.65, 95% confidence interval –1.17 to -0.13; p = 0.014) and pain interference (adjusted difference –0.68, 95% confidence interval –1.29 to -0.08; p = 0.026), as measured on the Brief Pain Inventory subscales (scale 0–10). People receiving the Support and Treatment After joint Replacement pathway had lower NHS and Personal Social Services costs (–£724, 95% confidence interval –£150 to £51) and higher quality-adjusted life-years (0.03, 95% confidence interval –0.008 to 0.06) than those with usual care. The Support and Treatment After joint Replacement pathway was cost-effective with an incremental net monetary benefit at the £20,000 per quality-adjusted life-year threshold of £1256 (95% confidence interval £164 to £2348), indicating a 98.79% probability that the intervention is the cost-effective option. Participants found the Support and Treatment After joint Replacement pathway acceptable, with opportunities to receive information and discuss concerns while ensuring further treatment and support. In systematic reviews considering treatments for chronic pain after surgery we identified some unifactorial interventions that merit further research after knee replacement. Health-care professionals delivering and implementing the Support and Treatment After joint Replacement pathway valued its focus on neuropathic pain and psychosocial issues, enhanced patient care, formalised referrals, and improved pain management. Stakeholders supported pathway implementation. LIMITATIONS: Database analyses were limited to factors recorded in data sets. Pain was only measured 6 months after surgery. However, analyses including large numbers of centres and patients should be generalisable across the NHS. In many studies found in systematic reviews, long-term pain was not a key outcome. CONCLUSIONS: The Support and Treatment After joint Replacement pathway is a clinically effective and cost-effective, acceptable intervention for the management of chronic pain after knee replacement. Unifactorial interventions merit further study before inclusion in patient care. People with pain should be empowered to seek health care, with the support of health-care professionals. FUTURE WORK: Future work should include research relating to the implementation of the Support and Treatment After joint Replacement pathway into the NHS, an assessment of its long-term clinical effectiveness and cost-effectiveness and wider application, and an evaluation of new interventions for incorporation in the pathway. It will also be important to design and conduct research to improve communication between patients and health-care professionals before surgery; explore whether or not education and support can enable earlier recognition of chronic pain; consider research that may identify how to support people’s feelings of disconnectedness from their new knee; and design and evaluate a pre-surgical intervention based on risk factors. STUDY REGISTRATION: All systematic reviews were registered on PROSPERO (CRD42015015957, CRD42016041374 and CRD42017041382). The Support and Treatment After joint Replacement randomised trial was registered as ISRCTN92545361. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 11, No. 3. See the NIHR Journals Library website for further project information. People with severe knee osteoarthritis may have knee replacement surgery to reduce pain and disability. Although highly successful for many people, some people report long-term pain. Our research looked at why some people are more likely to have long-term pain, its personal and economic consequences, and how to prevent and treat it. We reviewed previous research; analysed UK health-care databases; interviewed and met with patients, surgeons and health-care professionals; and developed and evaluated a new care pathway for patients with pain after knee replacement. We found that about one in seven people experience significant pain 6 months after knee replacement. For many, pain fluctuates over time. Some people with long-term pain feel that nothing more can be done to help and that further treatments may even cause harm. Changes to aspects of patient health and care merit further research as they may prevent the development of long-term pain. The Support and Treatment After joint Replacement pathway comprises a detailed assessment by a trained health-care professional; referral to appropriate services, such as an orthopaedic surgeon, physiotherapist, general practitioner for treatment of depression or anxiety, or pain specialist; and telephone follow-up. A total of 363 people with pain at 3 months after their knee replacement were randomly allocated to receive either the Support and Treatment After joint Replacement pathway or their hospital’s usual care. Participants were followed for 1 year to assess their long-term pain. We also looked at health-care costs and the acceptability of the Support and Treatment After joint Replacement pathway to patients and health-care professionals. This research was supported by a dedicated patient advisory group. For people with pain after knee replacement, the Support and Treatment After joint Replacement pathway leads to reduced long-term pain severity and reduced interference with everyday life, and is acceptable to patients and health-care professionals. NHS, personal social services and patient costs were lower in the group receiving the Support and Treatment After joint Replacement pathway. eng
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    Risk Factors for Failure of Total Ankle Replacements: A Data Linkage Study Using the National Joint Registry and NHS Digital
    (SAGE, 2023-07-01) Jennison, T.; Ukoumunne, O. C.; Lamb, S.; Sharpe, I.; Goldberg, A.
    BACKGROUND: Despite the increasing numbers of ankle replacements, there remains debate about which patients should undergo an ankle replacement, and there are limited studies analyzing risk factors for failure of an ankle replacement. The primary aim of this study is to analyze the risk factors for failure of total ankle replacements. METHODS: A data linkage study combining the National Joint Registry (NJR) Data and NHS (National Health Service) Digital data was performed. The primary outcome of failure is defined as the removal or exchange of any components of the implanted device. Kaplan-Meier survival charts were used to illustrate survivorship. Multivariable Cox proportional hazards regression models were fitted to analyze potential risk factors for failures or ankle replacements. RESULTS: The overall 5-year survival was 90.2% (95% CI 89.2%-91.1%). In multivariable (adjusted) Cox regression models, only age (hazard ratio [HR] 0.96, 95% CI 0.94-0.97), body mass index (BMI; HR 1.03, 95% CI 1.01-1.06), and underlying etiology (HR 0.88, 95% CI 0.80-0.97) were associated with an increased risk of failure. CONCLUSION: This study demonstrates that younger patients and those with an increased BMI have an increased risk of failure of a primary ankle replacement. We also show that rheumatoid patients have higher survivorship than those with osteoarthritis. LEVEL OF EVIDENCE: Level III, retrospective cohort study.
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    Predictors of poor outcome following lumbar spinal fusion surgery: a prospective observational study to derive two clinical prediction rules using British Spine Registry data
    (Springer, 2023-07-01) Rushton, A. B.; Jadhakhan, F.; Verra, M. L.; Emms, A.; Heneghan, N. R.; Falla, D.; Reddington, M.; Cole, A. A.; Willems, P. C.; Benneker, L.; Selvey, D.; Hutton, M.; Heymans, M. W.; Staal, J. B.
    PURPOSE: Lumbar spinal fusion surgery (LSFS) is common for lumbar degenerative disorders. The objective was to develop clinical prediction rules to identify which patients are likely to have a favourable outcome to inform decisions regarding surgery and rehabilitation. METHODS: A prospective observational study recruited 600 (derivation) and 600 (internal validation) consecutive adult patients undergoing LSFS for degenerative lumbar disorder through the British Spine Registry. Definition of good outcome (6 weeks, 12 months) was reduction in pain intensity (Numerical Rating Scale, 0-10) and disability (Oswestry Disability Index, ODI 0-50) > 1.7 and 14.3, respectively. Linear and logistic regression models were fitted and regression coefficients, Odds ratios and 95% CIs reported. RESULTS: Lower BMI, higher ODI and higher leg pain pre-operatively were predictive of good disability outcome, higher back pain was predictive of good back pain outcome, and no previous surgery and higher leg pain were predictive of good leg pain outcome; all at 6 weeks. Working and higher leg pain were predictive of good ODI and leg pain outcomes, higher back pain was predictive of good back pain outcome, and higher leg pain was predictive of good leg pain outcome at 12 months. Model performance demonstrated reasonable to good calibration and adequate/very good discrimination. CONCLUSIONS: BMI, ODI, leg and back pain and previous surgery are important considerations pre-operatively to inform decisions for surgery. Pre-operative leg and back pain and work status are important considerations to inform decisions for management following surgery. Findings may inform clinical decision making regarding LSFS and associated rehabilitation.
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    Improving the quality of rehabilitation following anterior cruciate ligament reconstruction surgery, in an outpatient physiotherapy department
    (BMJ, 2023-07-01) Henning, M.; Henning, R.; Dummett, J.
    Anterior cruciate ligament reconstruction (ACLR) is a type of orthopaedic knee surgery and physiotherapy rehabilitation is undertaken for several months postoperatively, often with the aim of returning the patient to sport. Variations in postoperative protocols to guide rehabilitation exist between National Health Service (NHS) Trusts. Although there is no single guideline to guide clinicians, strong evidence does support several clinical measures to be included post-ACLR, to improve outcomes and reduce the need for revision surgery. This project aimed to align our NHS Trust's ACLR physiotherapy care with best-evidence.A literature review was completed to establish key quality standards for ACLR rehabilitation. A retrospective notes audit was then undertaken to quantify the baseline quality of care, measured against these standards. Quality improvement methods were used to improve the quality of care and postoperative rehabilitation processes for ACLR patients. A new evidence-based, postoperative rehabilitation protocol was created, a core group of clinicians was formed to see ACLR patients and a rehabilitation class, solely for ACLR patients was also implemented.The key process measure for the project was patients engaging in 'criteria-driven progressions of rehabilitation'. This 'criteria-driven progressions' rate increased from 0% at baseline to 100% during the project period. Overall, non-attendance rates maintained at a similar level from 5.4% at baseline to a final rate of 4.8%. There was also an increase in mean 'return to sport' times, from 6 to 9.9 months, which is in line with best-evidence recommendations.The previous rehabilitation provided in our trust was not aligned with current evidence. This quality improvement project has led to improvements in patient care and lessons from the project will allow other trusts to learn from the changes made, to improve their own care pathways.