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The Bone & Joint Journal
Vol. 100-B, Issue 8 | Pages 1080 - 1086
1 Aug 2018
Charalampidis A Möller A Wretling M Brismar T Gerdhem P

Aims

There is little information about the optimum number of implants to be used in the surgical treatment of idiopathic scoliosis. Retrospective analysis of prospectively collected data from the Swedish spine register was undertaken to discover whether more implants per operated vertebra (implant density) leads to a better outcome in the treatment of idiopathic scoliosis. The hypothesis was that implant density is not associated with patient-reported outcomes, the correction of the curve or the rate of reoperation.

Patients and Methods

A total of 328 patients with idiopathic scoliosis, aged between ten and 20 years at the time of surgery, were identified in the Swedish spine register (Swespine) and had patient reported outcomes including the Scoliosis Research Society 22r instrument (SRS-22r) score, EuroQol 5 dimensions quality of life, 3 level (EQ-5D-3L) score and a Viual Analogue Score (VAS) for back pain, at a mean follow-up of 3.1 years and reoperation data at a mean follow-up of 5.5 years. Implant data and the correction of the curve were assessed from radiographs, preoperatively and a mean of 1.9 years postoperatively. The patients were divided into tertiles based on implant density. Data were analyzed with analysis of variance, logistic regression or log-rank test. Some analyses were adjusted for gender, age at the time of surgery, the flexibility of the major curve and follow-up.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 20 - 20
1 Oct 2022
Newton C Singh G O'Neill S Diver C Booth V Logan P O'Sullivan K O'Sullivan P
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Purposes of the study and background. Cognitive Functional Therapy (CFT) is a psychologically informed, physiotherapist-led intervention that targets the biopsychosocial complexity of persistent low back pain (LBP). CFT has demonstrated positive outcomes in two randomised controlled trials (RCT) but has not previously been evaluated in the United Kingdom National Health Service (NHS). This study aimed to determine the feasibility of completing a definitive RCT, that will evaluate the clinical and cost-effectiveness of CFT in comparison to usual physiotherapy care (UPC) for people with persistent LBP in the NHS. Methods and results. A two-arm parallel feasibility RCT compared CFT with UPC in participants with persistent LBP. Data concerning study processes, resources, management and patient reported outcome measures (disability, pain intensity, quality of life and psychosocial function) were collected at baseline, three and six-month follow-up, analysed and evaluated in order to establish feasibility. Sixty participants (n=30 CFT and n=30 UPC) were recruited with 71.6% (n=43) retained at six-month follow-up. CFT was delivered to fidelity, relevant and clinically important outcome data were rigorously collected and CFT was tolerated by participants with no safety concerns. The Roland-Morris disability questionnaire was the most suitable primary outcome measure and sample size calculations were completed for a definitive RCT. Intention to treat analysis indicated a signal of effect in favour of CFT with moderate and large between group effect sizes observed across outcome measures at six-month follow-up. Conclusion. It is feasible to conduct a randomised study of CFT in comparison to UPC for NHS patients. A future fully powered clinical and cost effectiveness RCT could be completed. Conflicts of interest: No conflicts of interest. Sources of funding: Chartered Society of Physiotherapy, Physiotherapy Research Foundation


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_11 | Pages 27 - 27
1 Sep 2021
Hess GM Golan J Mozsko S Duarte J Jarzem P Martens F
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Lumbar fusion remains the gold standard for the treatment of discogenic back pain. Total disc replacement has fallen out of favor in many institutions. Other motion preservation alternatives, such as nucleus replacement, have had limited success and none are commercially available at this time. Two prospective, nonrandomized multicenter studies of lumbar disc nucleus replacement using the PerQdisc 2.0 nucleus replacement device in patients with lumbar discogenic back pain. Early clinical results are presented. A total of 16 patients from 4 international sites (Germany, Paraguay, Canada and Belgium) were enrolled in the trial between May 2019 and February 2021. Data collection points include baseline and postoperatively at 1, 2, 6, and 12 months. Clinical outcome measures were obtained from the Visual Analog Scale (VAS) for back and leg pain, Oswestry Disability Index (ODI), SF-12V2, Analgesic Score (AS), and radiographic assessments. Prospectively gathered data on patient reported outcomes, neurological outcome, surgical results, radiological analysis, and any adverse events. 16 patients had successful implantation of the device. There have been no expulsions of the device. Early postoperative results are available in 13/16 patients at 6 months and 11/16 patients at 12 months. There have been 4 (25%) revision surgeries 3–12 months post implantation between the two trials. 12 of 13 (92%) patients had Minimal Clinically Important Difference (MCID) in ODI at 6 months and 10 of 11 (91%) at 12 months. Mean decrease in ODI from baseline to 12 months was 44.8. At 12 months 8 (73%) patients are not taking pain medication, 1 (9%) patient is taking a narcotic for pain management. 73% of patients are working without restrictions at 12 months post implant. Early clinical and technical results are encouraging. Long term follow up is essential and is forthcoming. Additional patient recruitment and data points are ongoing. FDA/Drug Status Investigational/Not approved


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 52 - 52
1 Sep 2019
Afzali T Lauridsen H Thomsen J Hartvigsen J Jensen M Riis A
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Background. A cornerstone in treating low back pain (LBP) is the provision of information to patients, and the internet is increasingly being used as a source of health information delivery. However, the effect of and satisfaction with online information have been questioned. Purpose. To develop a multi-item instrument to measure an index score of satisfaction with online information for patients with LBP. Methods. The conceptualization of this patient reported outcome is modelled on the assumption of a formative model. The first draft of the questionnaire was developed based on a previous published interview study of 15 patients and evaluated for face validity by seven experts. The second draft of the questionnaire was pilot-tested in 20 patients to optimize content validity. Patients were recruited from a rehabilitation center and from social media. Results. An eight-item questionnaire was developed after assessing content and face validity. The items were related to design, readability, customization, credibility, usability, and coping. A labelled categorical scale was used for response options. Each item is scored from 0–3, where 0 indicates not at all satisfied, 1 indicates little satisfaction, 2 indicates some satisfaction, and 3 indicates very satisfied giving an overall index score between 0 and 24 points. Conclusion. An eight-item questionnaire measuring satisfaction with an index score from 0–24 points has been developed. The OPSI questionnaire is now being tested for construct validity, reproducibility and interpretation on 150 patients with LBP. No conflicts of interest. Sources of funding: Funded by the Novo Nordic Foundation (NNF17OC0024422)


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 17 - 17
1 Sep 2019
Reddington M Walters S Cohen J Baxter S Cole A
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Purpose of the study. To investigate the feasibility of undertaking a definitive Randomised Controlled Trial (RCT) to determine the effectiveness of early physiotherapy for sciatica. Methods. Patients over 18 presenting to their G.P with sciatica were eligible to participate in the study, those without a clear understanding of English or had co-morbidities preventing rehabilitation were ineligible. Process and patient reported outcomes including self-rated disability, pain and general health, were collected at baseline, 6,12 and 26 weeks post randomisation. Participants were randomised into either early physiotherapy, receiving treatment within 2 weeks after randomisation or usual care with physiotherapy commencing 6 weeks post randomisation. Both groups received up to 6 treatment sessions of a patient-centred, goal orientated physiotherapy programme specific to their needs. Results. 80 participants were recruited in 10 G.P practices over 34 weeks and randomised to either early physiotherapy (n= 42) or usual care (n=38). Follow-up rates at 26 weeks were 36 (86%) in the early intervention physiotherapy group and 32 (84%) in the usual care. All feasibility objectives were achieved. The mean area under the curve for the Oswestry Disability Index (ODI) over the 26 weeks was and 16.0 (SD 14.0) in the early physiotherapy group and 16.6 (SD 11.4) in the usual care group. A difference of −0.6 (95% CI: −0.68 to 5.6) in favour of the intervention group. Conclusion. The results of the study suggest a full RCT is feasible and will provide evidence as to the optimal timing of physiotherapy for patients with sciatica. No conflicts of interest for any authors. Sources of funding: MR is the recipient of a HEE/NIHR Clinical Doctoral Research Fellowship, which funded the study


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXI | Pages 27 - 27
1 Jul 2012
Sandford L Yuen S Upadhyay N Beebee M Sadler M Nesbitt J Madhavan P Steele N Thorpe P
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Surgery for spinal deformity was previously carried out only in teaching hospitals in the United Kingdom. With increasing numbers of patients especially adults, seeking treatment for spinal deformity, the number of centres offering treatment for spinal deformity is going to have to increase. The deformity part of the Spinal Surgical Service in the District General Hospital in Taunton started in 2005. This paper is an audit of this deformity service. It looks at two key areas – that of patient satisfaction and patient reported outcomes of surgery. Patient satisfaction was assessed by a validated questionnaire that evaluated a patient's perception of consultations, consent, preoperative assessment, operative and post operative experience and follows up visits. Patient reported outcomes were evaluated using the SRS 30 questionnaire. 104 patients were contacted and 95 patients (91%) responded. The overall patient satisfaction rate was 96%, with 87% very pleased with the result of surgery, 80% felt that their body shape had improved considerably, 62% had an increased ability to carry out day to day activities to a much higher level and 78% had significantly decreased pain after surgery. The results of the different domains of the SRS questionnaire also supported this. The authors believe that this audit proves that it is possible to provide a spinal deformity service in a District General Hospital in the United Kingdom safely and effectively with a high degree of patient satisfaction. Audits of this kind are required to compare results of treatment between different centres and establish standards


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 122 - 122
1 Apr 2012
Slator N Wilby M Tsegaye M
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To audit patient satisfaction throughout the perioperative period amongst emergency and elective admissions in the spinal team. 92 patients were identified whom underwent operations within a 3 month period using the operating database. A self administered postal questionnaire was sent to assess preoperative waiting time, quality of preoperative assessment and information given, assessment of their admission, their experience throughout hospital stay and the quality of their post operative assessment and discharge. Patient reported outcomes (PROMS). Response rate 35% (32/92) of which 24 (14F 10M) were elective admissions and 8 emergency admissions (2F 6M). Average wait for elective procedure was 5.7 weeks (median 2). 63% of elective patients were seen in prescreening clinic and 79% of these received an information booklet prior to operation. 22% of patients had delayed discharge due to non clinical causes including awaiting transport, awaiting medications and physiotherapy clearance. 88% of patients reported they were given adequate information regarding post-operative daily activities. 79% of elective patients reported seeing a doctor on the day of their discharge however only 38% reported seeing a physiotherapist postoperatively. This fell to 0% for patients operated on a Friday. Although 94% of patients reported that they were satisfied with the overall care they were given, they reported certain aspects of their clinical care being less than optimal. Trust wide assessment of patient reported outcomes to assess and improve the quality of care against national guidelines. Ethics Approval: Self questionnaire approved by ethics committee


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_6 | Pages 29 - 29
1 Feb 2016
Fawkes C Carnes D Froud R
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Background to the study:. The use of Patient Reported Outcome Measures (PROMs) is being increasingly advocated but data are still being collected using paper systems. This is costly and environmentally challenging. New innovations are required to balance the challenges of capturing PROM data while considering budgets, and access to IT, and patient choice. Purpose of the study:. To develop and test a mobile phone and web app for collecting patient reported outcomes about musculoskeletal symptoms. Methods:. The content of the app was developed following qualitative work with patients and clinicians, and a review of measurement properties of different PROMs. Early versions of the app underwent α- and β-testing to identify issues with functionality. The PROM app was pilot-tested to assess feasibility, responsiveness, and test-retest reliability of the PROMs. The pilot version of the app contained demographic data, the Roland Morris Disability Questionnaire (RMDQ), the Bournemouth Questionnaire, and Visual Analogue Scale for pain. At follow-up additional questions exploring patient satisfaction and experience of care, plus a transition question were asked. Results:. A total of 517 patient codes were allocated. Completed datasets were gathered from patients (N=92) potentially indicating issues with acceptability and feasibility. Data analysis indicated good completion of questions. The RMDQ appeared to be largely redundant in this patient population and was removed in the final version of the app. Conclusion:. The app performed well when used by participants. Support is required for practitioners and patients to implement this electronic data capture system


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_6 | Pages 8 - 8
1 Feb 2016
Newell D Field J
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Background:. Low Back Pain and Neck Pain rank 1 and 4 on the causes of years lost to disability (YLDs) in the UK. Treatment options are broad including popular approaches such as chiropractic care but with NHS funding limited to recent initiatives such as Any Qualified Provider (AQP). Method:. Eleven chiropractic practices with AQP contracts took part in the study. As part of routine clinical practice, patients are entered onto a web based patient reported outcome system that sends automated e mails links to questionnaires, prior to the initial visit (includes the Bournemouth Questionnaire (BQ) and STarT Back, and at 14, 30 and 90 days (BQ and Patient Global Impression of Change (PGIC)). Data from subjects consenting for such use were used in the analysis. Results:. Three thousand three hundred thirty nine patients filled out baseline questionnaires, one third of which were NHS. Response rates at 90 days were 33 and 23% in NHS and private groups respectively. NHS referral status was associated with reduced adjusted odds only at 14 days whereas at 30 and 90 days referral groups were equally likely to have improved. Chronicity, lower baseline BQ scores and not improved at previous follow up points were associated with poor recovery. High-risk STarT Back patients were associated with poorer recovery compared to low risk patients but only in the NHS group. Conclusion:. Factors predicting favourable outcomes were similar between NHS and private groups. At most only 35% of the variance was explained with dominance from non-modifiable prognostic factors


Bone & Joint Open
Vol. 2, Issue 3 | Pages 198 - 201
1 Mar 2021
Habeebullah A Rajgor HD Gardner A Jones M

Aims

The British Spine Registry (BSR) was introduced in May 2012 to be used as a web-based database for spinal surgeries carried out across the UK. Use of this database has been encouraged but not compulsory, which has led to a variable level of engagement in the UK. In 2019 NHS England and NHS Improvement introduced a new Best Practice Tariff (BPT) to encourage input of spinal surgical data on the BSR. The aim of our study was to assess the impact of the spinal BPT on compliance with the recording of surgical data on the BSR.

Methods

A retrospective review of data was performed at a tertiary spinal centre between 2018 to 2020. Data were collated from electronic patient records, theatre operating lists, and trust-specific BSR data. Information from the BSR included operative procedures (mandatory), patient consent, email addresses, and demographic details. We also identified Healthcare Resource Groups (HRGs) which qualified for BPT.


The Bone & Joint Journal
Vol. 97-B, Issue 12 | Pages 1675 - 1682
1 Dec 2015
Strömqvist F Strömqvist B Jönsson B Gerdhem P Karlsson MK

Lumbar disc herniation (LDH) is uncommon in youth and few cases are treated surgically. Very few outcome studies exist for LDH surgery in this age group. Our aim was to explore differences in gender in pre-operative level of disability and outcome of surgery for LDH in patients aged ≤ 20 years using prospectively collected data. From the national Swedish SweSpine register we identified 180 patients with one-year and 108 with two-year follow-up data ≤ 20 years of age, who between the years 2000 and 2010 had a primary operation for LDH. Both male and female patients reported pronounced impairment before the operation in all patient reported outcome measures, with female patients experiencing significantly greater back pain, having greater analgesic requirements and reporting significantly inferior scores in EuroQol (EQ-5D-index), EQ-visual analogue scale, most aspects of Short Form-36 and Oswestry Disabilities Index, when compared with male patients. Surgery conferred a statistically significant improvement in all registered parameters, with few gender discrepancies. Quality of life at one year following surgery normalised in both males and females and only eight patients (4.5%) were dissatisfied with the outcome. Virtually all parameters were stable between the one- and two-year follow-up examination. LDH surgery leads to normal health and a favourable outcome in both male and female patients aged 20 years or younger, who failed to recover after non-operative management. Cite this article: Bone Joint J 2015;97-B:1675–82


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_6 | Pages 13 - 13
1 Feb 2016
Chohan A Haworth L Janssen J Selfe J
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Background:. Larger breasted women are at higher risk of wearing ill-fitting breast-support garments. Failure to support breasts during everyday activity can lead to physiological conditions including back and breast pain. This study aimed to identify initial and short-term (4 weeks) biomechanical change and patient reported outcome measures (PROMS) in larger breasted women with non-specific back pain (NSBP) when wearing different breast-support garments. Methods & Results:. 20 females (Age: 32.1±9.4 years; Bra sizes: 36DD-32K) with NSBP were recruited using modified red flags screening. Participants were tested initially in their usual bra, followed by the professionally-fitted and Optifit bras, in randomised order. Pre/post assessments comprised an established bra-fit assessment, body chart analysis, frequency of wear and pain, continuous-pain intensity (SF-MPQ-2), back stiffness and discomfort, neck disability and thoracic posture in standing using 3D-movement analysis. 100% of Usual and 90% of professionally-fitted bras failed the bra-fit assessment, compared to 5% with the Optifit. Though worn the least on average, a short-term intervention with the Optifit bra resulted in significant reductions in reported thoracic pain, clinically important reductions in neck disability, back pain frequency, continuous-pain intensity, stiffness and discomfort compared to the other bras. The Optifit and professionally-fitted bras significantly reduced reported lumbosacral pain compare to the usual bra. There was no initial change in thoracic posture with the Optifit bra however, significant improvements in flexion-extension posture were seen post-intervention. Conclusions:. Following a short-term intervention, larger breasted women with NSBP appear to show some clinically important improvements. Provision of correctly fitting breast-support garments may contribute to better clinical management of NSBP in these women


Introduction. Patient reported outcome measures (PROMs) and psychological aspects of spinal conditions play an important role in its management. Disability benefit in the social welfare system is being closely scrutinized. The PHQ9 and GAD7 are used widely in general practice to aid assessment of depression and anxiety/somatization. To date, their use in the spinal surgery out patient setting has not been assessed. Materials and Method. Over a one-year period the senior author saw 516 new patients. Each patient completed a standard spinal assessment questionnaire consisting of several demographic/aetiological questions and PROMs (VAS back, VAS leg, ODI/NDI, PHQ9 and GAD7). An analysis of these scores was performed. Results. The mean age was 54 years with 237 males and 279 females. The mean VAS Neck/Back was 6.7, VAS Limb 6, ODI/NDI 48, PHQ9 12 and GAD7 8.7. The PHQ9 and GAD7 correlated strongly with the VAS and ODI/NDI scores (r=0.3–0.4, p<0.0001). The PHQ9 correlated strongly with the GAD7 (r=0.83, p<0.0001). 163 patients (31.6%) were receiving disability benefit. Disability benefit was strongly associated with increasing age, VAS, ODI/NDI, PHQ9 and GAD7 scores (p<0.0001). Patients receiving disability benefit have more concerns regarding their pain and worse PROMs. Similar findings were found in the subgroup of 81 patients with chronic degenerative low back pain. Conclusion. The PHQ9 and GAD7 scores appear to correlate well with the standard spinal disability assessment PROMs (VAS and ODI/NDI). Patients receiving disability benefit appear to have worse PROMs including worse measures of depression and anxiety/somatization


The Bone & Joint Journal
Vol. 101-B, Issue 12 | Pages 1534 - 1541
1 Dec 2019
Lagerbäck T Möller H Gerdhem P

Aims

The purpose of this study was to investigate the risk of additional surgery in the lumbar spine and to describe long-term changes in patient-reported outcomes after surgery for lumbar disc herniation in adolescents and young adults.

Patients and Methods

We conducted a retrospective study design on prospectively collected data from a national quality register. The 4537 patients were divided into two groups: adolescents (≤ 18 years old, n = 151) and young adults (19 to 39 years old, n = 4386). The risk of additional lumbar spine surgery was surveyed for a mean of 11.4 years (6.0 to 19.3) in all 4537 patients. Long-term patient-reported outcomes were available at a mean of 7.2 years (5.0 to 10.0) in up to 2716 patients and included satisfaction, global assessment for leg and back pain, Oswestry Disability Index, visual analogue scale for leg and back pain, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary and Physical Component Summary scores. Statistical analyses were performed with Cox proportional hazard regression, chi-squared test, McNemar’s test, Welch–Satterthwaite t-test, and Wilcoxon’s signed-rank test.