Oxford Spine Buddies: an acceptability and feasibility project for peer-to-peer support in a spine sarcoma service.

BACKGROUND: Primary bone and soft tissue sarcoma of the spine are rare and account for less than 0.2% of all neoplasm incidences. Following a patient and public involvement event, the need to explore patient support pathways was identified, which initiated this service evaluation project. AIM: To determine the acceptability and feasibility of a peer-to-peer support project among people using the spine sarcoma service. METHODS: Users were paired and introduced via Microsoft Teams. Quantitative and qualitative data both pre- and post-introduction of a buddy were collected. FINDINGS: Service users felt that, although they would have preferred having a buddy at the time of their diagnosis, being allocated a buddy made them feel reassured and better supported. CONCLUSION: The project was well received and preliminary data are encouraging. Therefore, due to early findings from the first participants, the service is continuing to roll out the buddy programme.

Early Recovery Following Total and Unicompartmental Knee Arthroplasty Assessed Using Novel Patient-Reported Measures.

BACKGROUND: The early postoperative recovery period following unicompartmental (UKA) and total knee arthroplasty (TKA) is an important area for research with increasingly sensitive metrics and new technologies. This study uses 2 recently developed patient-reported scores to compare the recovery following UKA and TKA. METHODS: Two consecutive cohorts of 37 UKAs and 33 TKAs completed the Oxford Arthroplasty Early Recovery Score (OARS) and the Oxford Arthroplasty Early Change Score (OACS) on days 1, 2, 3, 7, 14, and week 6. The Short Form-36 version 2 was also completed on weeks 1, 2, and 6. Improvements within cohorts and comparisons between cohorts were assessed. RESULTS: For both UKA and TKA the speed of recovery was rapid early on and then progressively decreased. At all time points, the UKA cohort reported similar or significantly better scores than the TKA cohort. The overall OARS (P < .001) showed that UKA recovered, shown as improvement on the OARS, 2-3 times faster than TKA. OARS subscales demonstrated that UKA had better Function/Mobility (P = .003) particularly early in the recovery, and better Nausea/Feeling Unwell (P < .001) and Fatigue/Sleep (P = .009) later in the recovery. UKA also had less pain at 2 weeks (P = .03). There was no significant difference between UKA and TKA OACS. UKA had significantly better scores in 3 of the 8 Short Form-36 domains, with the largest difference being in Role-Emotional (P = .003). CONCLUSION: The OARS is useful for the assessment of postoperative recovery. This study provides direct evidence that recovery following UKA is better and 2-3 times faster than following TKA. All differences may be explained by the less invasive nature of UKA.

Health Care Professionals' Perceptions of the Arthroplasty Patient Experience: Planning Phase in the Development of a Patient-Reported Outcome Measure.

PURPOSE: The aim of this study was to explore health care professionals' perceptions and perspectives of surgery and early recovery for patients undergoing lower limb arthroplasty. DESIGN: Thematic analysis with semi-structured qualitative interviews. METHODS: Following ethical approval, interviews were performed with recovery room nurses (n=3), ward nurses (n=2), surgeons (n=5), anesthesiologists (n=5), physiotherapists (n=5), and occupational therapists (n=2). Data were analyzed using an in-depth narrative thematic analysis method. NVivo qualitative data analysis software was used. FINDINGS: Three main themes evolved from the interviews: immediate patient recovery issues, discharge criteria, and priorities during hospitalization from health care providers' perspectives. CONCLUSIONS: The early postoperative recovery period can be a challenging time for health care providers and patients alike. However, identifying key areas of importance can provide insight and guide focus in clinical practice, thus improving patient recovery.

Early recovery following lower limb arthroplasty: Qualitative interviews with patients undergoing elective hip and knee replacement surgery. Initial phase in the development of a patient-reported outcome measure.

AIMS AND OBJECTIVES: To explore the patients' perspective of surgery and early recovery when undergoing lower limb (hip or knee) arthroplasty. BACKGROUND: Lower limb arthroplasty is a commonly performed procedure for symptomatic arthritis, which has not responded to conservative medical treatment. Each patient's perspective of the surgical process and early recovery period impacts on their quality of life. DESIGN: Open, semistructured qualitative interviews were used to allow for a deeper understanding of the patient perspective when undergoing a hip or knee arthroplasty. METHODS: Following ethical approval, 30 patients were interviewed between August and November 2016 during the perioperative period while undergoing an elective hip or knee arthroplasty (n = 30). The interviews were performed between the day of surgery and a nine-week postoperative clinic appointment. Data were analysed using an in-depth narrative thematic analysis method. NVivo qualitative data analysis software was used. RESULTS: Seven main themes evolved from the interviews: "improving function and mobility", "pain", "experiences of health care", "support from others", "involvement and understanding of care decisions", "behaviour and coping" and "fatigue and sleeping". CONCLUSIONS: The early postoperative recovery period is of vital importance to all surgical patients. This is no different for the orthopaedic patient. However, identifying key self-reported areas of importance from patients can guide clinical focus for healthcare professionals. RELEVANCE TO CLINICAL PRACTICE: To have specific patient-reported information regarding key areas of importance during the perioperative phase is invaluable when caring for the orthopaedic surgical patient. It gives insight and understanding in to this increasing population group. This study has also served as a starting point in the development of a questionnaire which could be used to assess interventions in the lower limb arthroplasty population. These results will influence both items and content of the questionnaire.

Long-term outcomes of over 8,000 medial Oxford Phase 3 Unicompartmental Knees-a systematic review.

Background and purpose - There is debate as to the relative merits of unicompartmental and total knee arthroplasty (UKA, TKA). Although the designer surgeons have achieved good results with the Oxford UKA there is concern over the reproducibility of these outcomes. Therefore, we evaluated published long-term outcomes of the Oxford Phase 3 UKA. Patients and methods - We searched databases to identify studies reporting ≥10 year outcomes of the medial Oxford Phase 3 UKA. Revision, non-revision, and re-operation rates were calculated per 100 component years (% pa). Results - 15 studies with 8,658 knees were included. The annual revision rate was 0.74% pa (95% CI 0.67-0.81, n = 8,406) corresponding to a 10-year survival of 93% and 15-year survival of 89%. The non-revision re-operation rate was 0.19% pa (95% CI 0.13-0.25, n = 3,482). The re-operation rate was 0.89% pa (95% CI 0.77-1.02, n = 3,482). The most common causes of revision were lateral disease progression (1.42%), aseptic loosening (1.25%), bearing dislocation (0.58%), and pain (0.57%) (n = 8,658). Average OKS scores were 40 at 10 years (n = 3,417). The incidence of medical complications was 0.83% (n = 1,443). Interpretation - Very good outcomes were achieved by both designer and non-designer surgeons. The PROMs, medical complication rate, and non-revision re-operation rate were better than those found in meta-analyses and publications for TKA but the revision rate was higher. However, if failure is considered to be all re-operations and not just revisions, then the failure rate of UKA was less than that of TKA.

Perioperative adjuvant corticosteroids for postoperative analgesia in knee arthroplasty.

Background and purpose - Immediate postoperative pain management offered in knee arthroplasty is suboptimal in up to one-third of patients resulting in high opiate consumption and delayed discharge. In this meta-analysis we investigate the analgesic effect and safety of perioperative adjuvant corticosteroids in knee arthroplasty. Methods - Databases Medline, Embase, and Central were searched for randomized studies comparing the analgesic effect of adjuvant perioperative corticosteroids in knee arthroplasty. Our primary outcome was pain score at 24 hours postoperatively. Secondary outcomes included pain at 12, 48, and 72 hours, opiate consumption, postoperative nausea and vomiting, infection, and discharge time. Systemic (intravenous) and local (intra-articular) corticosteroids were analyzed separately. Results - 14 randomized controlled trials (1,396 knees) were included. Mean corticosteroid dosages were predominantly 50-75mg oral prednisolone equivalents for both systemic and local routes. Systemic corticosteroids demonstrated statistically significant and clinically modest reductions in pain at 12 hours by -1.1 points (95%CI -2.2 to 0.02), 24 hours by -1.3 points (CI -2.3 to -0.26) and 48 hours by -0.4 points (CI -0.67 to -0.04). Local corticosteroids did not reduce pain. Opiate consumption, postoperative nausea and vomiting, infection, or time till discharge were similar between groups. Interpretation - Corticosteroids modestly reduce pain postoperatively at 12 and 24 hours when used systemically without any increase in associated risks for dosages between 50 and 75 mg oral prednisolone equivalents.

Liposomal bupivacaine infiltration at the surgical site for the management of postoperative pain.

BACKGROUND: Despite multi-modal analgesic techniques, acute postoperative pain remains an unmet health need, with up to three quarters of people undergoing surgery reporting significant pain. Liposomal bupivacaine is an analgesic consisting of bupivacaine hydrochloride encapsulated within multiple, non-concentric lipid bi-layers offering a novel method of sustained-release analgesia. OBJECTIVES: To assess the analgesic efficacy and adverse effects of liposomal bupivacaine infiltration at the surgical site for the management of postoperative pain. SEARCH METHODS: On 13 January 2016 we searched CENTRAL, MEDLINE, MEDLINE In-Process, Embase, ISI Web of Science and reference lists of retrieved articles. We obtained clinical trial reports and synopses of published and unpublished studies from Internet sources, and searched clinical trials databases for ongoing trials. SELECTION CRITERIA: Randomised, double-blind, placebo- or active-controlled clinical trials in people aged 18 years or over undergoing elective surgery, at any surgical site, were included if they compared liposomal bupivacaine infiltration at the surgical site with placebo or other type of analgesia. DATA COLLECTION AND ANALYSIS: Two review authors independently considered trials for inclusion, assessed risk of bias, and extracted data. We performed data analysis using standard statistical techniques as described in the Cochrane Handbook for Systematic Reviews of Interventions, using Review Manager 5.3. We planned to perform a meta-analysis and produce a 'Summary of findings' table for each comparison however there were insufficient data to ensure a clinically meaningful answer. As such we have produced two 'Summary of findings' tables in a narrative format. Where possible we assessed the quality of evidence using GRADE. MAIN RESULTS: We identified nine studies (10 reports, 1377 participants) that met inclusion criteria. Four Phase II dose-escalating/de-escalating trials, designed to evaluate and demonstrate efficacy and safety, presented pooled data that we could not use. Of the remaining five parallel-arm studies (965 participants), two were placebo controlled and three used bupivacaine hydrochloride local anaesthetic infiltration as a control. Using the Cochrane tool, we judged most studies to be at unclear risk of bias overall; however, two studies were at high risk of selective reporting bias and four studies were at high risk of bias due to size (fewer than 50 participants per treatment arm).Three studies (551 participants) reported the primary outcome cumulative pain intensity over 72 hours following surgery. Compared to placebo, liposomal bupivacaine was associated with a lower cumulative pain score between the end of the operation (0 hours) and 72 hours (one study, very low quality). Compared to bupivacaine hydrochloride, two studies showed no difference for this outcome (very low quality evidence), however due to differences in the surgical population and surgical procedure (breast augmentation versus knee arthroplasty) we did not perform a meta-analysis.No serious adverse events were reported to be associated with the use of liposomal bupivacaine and none of the five studies reported withdrawals due to drug-related adverse events (moderate quality evidence).One study reported a lower mean pain score at 12 hours associated with liposomal bupivacaine compared to bupivacaine hydrochloride, but not at 24, 48 or 72 hours postoperatively (very low quality evidence).Two studies (382 participants) reported a longer time to first postoperative opioid dose compared to placebo (low quality evidence).Two studies (325 participants) reported the total postoperative opioid consumption over the first 72 hours: one study reported a lower cumulative opioid consumption for liposomal bupivacaine compared to placebo (very low quality evidence); one study reported no difference compared to bupivacaine hydrochloride (very low quality evidence).Three studies (492 participants) reported the percentage of participants not requiring postoperative opioids over initial 72 hours following surgery. One of the two studies comparing liposomal bupivacaine to placebo demonstrated a higher number of participants receiving liposomal bupivacaine did not require postoperative opioids (very low quality evidence). The other two studies, one versus placebo and one versus bupivacaine hydrochloride, found no difference in opioid requirement (very low quality evidence). Due to significant heterogeneity between the studies (I2 = 92%) we did not pool the results.All the included studies reported adverse events within 30 days of surgery, with nausea, constipation and vomiting being the most common. Of the five parallel-arm studies, none performed or reported health economic assessments or patient-reported outcomes other than pain.Using GRADE, the quality of evidence ranged from moderate to very low. The major limitation was the sparseness of data for outcomes of interest. In addition, a number of studies had a high risk of bias resulting in further downgrading. AUTHORS' CONCLUSIONS: Liposomal bupivacaine at the surgical site does appear to reduce postoperative pain compared to placebo, however, at present the limited evidence does not demonstrate superiority to bupivacaine hydrochloride. There were no reported drug-related serious adverse events and no study withdrawals due to drug-related adverse events. Overall due to the low quality and volume of evidence our confidence in the effect estimate is limited and the true effect may be substantially different from our estimate.

Liposomal bupivacaine peripheral nerve block for the management of postoperative pain.

BACKGROUND: Postoperative pain remains a significant issue with poor perioperative pain management associated with an increased risk of morbidity and mortality. Liposomal bupivacaine is an analgesic consisting of bupivacaine hydrochloride encapsulated within multiple, non-concentric lipid bi-layers offering a novel method of sustained release. OBJECTIVES: To assess the analgesic efficacy and adverse effects of liposomal bupivacaine infiltration peripheral nerve block for the management of postoperative pain. SEARCH METHODS: We identified randomised trials of liposomal bupivacaine peripheral nerve block for the management of postoperative pain. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2016, Issue 1), Ovid MEDLINE (1946 to January Week 1 2016), Ovid MEDLINE In-Process (14 January 2016), EMBASE (1974 to 13 January 2016), ISI Web of Science (1945 to 14 January 2016), and reference lists of retrieved articles. We sought unpublished studies from Internet sources, and searched clinical trials databases for ongoing trials. The date of the most recent search was 15 January 2016. SELECTION CRITERIA: Randomised, double-blind, placebo- or active-controlled clinical trials of a single dose of liposomal bupivacaine administered as a peripheral nerve block in adults aged 18 years or over undergoing elective surgery at any surgical site. We included trials if they had at least two comparison groups for liposomal bupivacaine peripheral nerve block compared with placebo or other types of analgesia. DATA COLLECTION AND ANALYSIS: Two review authors independently considered trials for inclusion in the review, assessed risk of bias, and extracted data. We performed analyses using standard statistical techniques as described in the Cochrane Handbook for Systematic Reviews of Interventions, using Review Manager 5. We planned to perform a meta-analysis, however there were insufficient data to ensure a clinically meaningful answer; as such we have produced a 'Summary of findings' table in a narrative format, and where possible we assessed the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation). MAIN RESULTS: We identified seven studies that met inclusion criteria for this review. Three were recorded as completed (or terminated) but no results were published. Of the remaining four studies (299 participants): two investigated liposomal bupivacaine transversus abdominis plane (TAP) block, one liposomal bupivacaine dorsal penile nerve block, and one ankle block. The study investigating liposomal bupivacaine ankle block was a Phase II dose-escalating/de-escalating trial presenting pooled data that we could not use in our analysis.The studies did not report our primary outcome, cumulative pain score between 0 and 72 hours, and secondary outcomes, mean pain score at 12, 24, 48, 72, or 96 hours. One study reported no difference in mean pain score during the first, second, and third postoperative 24-hour periods in participants receiving liposomal bupivacaine TAP block compared to no TAP block. Two studies, both in people undergoing laparoscopic surgery under TAP block, investigated cumulative postoperative opioid dose, reported opposing findings. One found a lower cumulative opioid consumption between 0 and 72 hours compared to bupivacaine hydrochloride TAP block and one found no difference during the first, second, and third postoperative 24-hour periods compared to no TAP block. No studies reported time to first postoperative opioid or percentage not requiring opioids over the initial 72 hours. No studies reported a health economic analysis or patient-reported outcome measures (outside of pain). The review authors sought data regarding adverse events but none were available, however there were no withdrawals reported to be due to adverse events.Using GRADE, we considered the quality of evidence to be very low with any estimate of effect very uncertain and further research very likely to have an important impact on our confidence in the estimate of effect. All studies were at high risk of bias due to their small sample size (fewer than 50 participants per arm) leading to uncertainty around effect estimates. Additionally, inconsistency of results and sparseness of data resulted in further downgrading of the quality of the data. AUTHORS' CONCLUSIONS: A lack of evidence has prevented an assessment of the efficacy of liposomal bupivacaine administered as a peripheral nerve block. At present there is a lack of data to support or refute the use of liposomal bupivacaine administered as a peripheral nerve block for the management of postoperative pain. Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.

Patient-Reported Outcome Measure for Early Postoperative Recovery Following Lower Limb Arthroplasty: A Systematic Review.

BACKGROUND: Lower limb arthroplasty is an effective surgical treatment option for patients with moderate to severe arthritis who have not responded to medical management. However, surgical interventions can lead to postoperative consequences such as limited mobility, pain, and infection. Consequently, improving postoperative recovery holds significant benefits for patients, health care professionals, and health care payers. The purpose of this review is to determine if any recovery tools exist that can effectively measure early postoperative recovery after hip or knee arthroplasty. METHODS: The following databases were searched; PubMed (Ovid), EMBASE (Ovid), Medline (Ovid), Web of Science (ISI Web of Knowledge), PsycINFO, Applied Social Sciences Index and Abstracts, Cochrane library, and SCOPUS. We restricted our search to English language articles and adult respondents. Data were extracted by 2 independent reviewers using a proforma spreadsheet, and existing quality criteria were applied. RESULTS: Our literature search identified 23 articles relating to development, assessment, and validation of 15 tools. Not all instruments demonstrated the same levels of quality. None of the tools found were specific to both the orthopedic arthroplasty population and early recovery periods. CONCLUSION: At the present time, there are no fully validated tools to assess early postoperative recovery during the first week following lower limb arthroplasty. A brief, easy-to-complete, reliable patient-reported tool could be of great use. It could not only aid in assessment of recovery but could also evaluate the efficacy of perioperative interventions such as drugs or surgical technique and provide a foundation for evidence-based care.

The development of a patient reported outcome measure for fatigue and breathlessness for patients with chronic heart failure (OxFAB).

BACKGROUND: Fatigue and breathlessness are the two most common and distressing symptoms for patients with chronic heart failure. They affect a patient's quality of life and ability to undertake activities of daily living. Currently there are no symptom specific measures for fatigue and breathlessness available or developed and validated for use with this patient group and no questionnaire that incorporates both symptoms into one measure. OBJECTIVE: To develop a patient-reported outcome measure for patients with chronic heart failure for their fatigue and breathlessness symptoms. METHODS: A three-staged, approach was used. In stage One in-depth qualitative patient-interviews on factors of fatigue and breathlessness in chronic heart failure were undertaken to provide question themes. Items from these interviews were generated and pilot questionnaires developed and tested. In Stage Two, exploratory factor analysis with item reduction and final testing of the questionnaire was performed. Stage Three involved validation testing. RESULTS: In Stage One, issues raised in interviews (n = 25) were used to generate items. Pilot questionnaires were developed and tested. Items were refined in the context of cognitive debrief interviews (n = 7) for possible inclusion in the final measure. Final testing of questionnaire properties with item reduction was carried out in Stage Two (n = 112). Validity and reliability were assessed in Stage Three (n = 96). Psychometric testing showed positive results, in internal consistency (Cronbach's alpha ranging from 0.8 to 0.94) and test-retest (no difference in means), content validity and relevance to patients. CONCLUSIONS: This questionnaire could be useful in the assessment of fatigue and breathlessness in patients living with chronic heart failure.

Efficacy of Liposomal Bupivacaine and Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Periarticular Anesthetic for Patients Undergoing Knee Replacement: A Randomized Clinical Trial.

Importance: More than half of patients who undergo knee replacement surgery report substantial acute postoperative pain. Objective: To evaluate the efficacy and cost-effectiveness of periarticular liposomal bupivacaine for recovery and pain management after knee replacement. Design, Setting, and Participants: This multicenter, patient-blinded, pragmatic, randomized clinical superiority trial involved 533 participants at 11 institutions within the National Health Service in England. Adults undergoing primary unilateral knee replacement for symptomatic end-stage osteoarthritis were enrolled between March 29, 2018, and February 29, 2020, and followed up for 1 year after surgery. Follow-up was completed March 1, 2021. A per-protocol analysis for each coprimary outcome was performed in addition to the main intention-to-treat analysis. Interventions: Two hundred sixty-six milligrams of liposomal bupivacaine admixed with 100 mg of bupivacaine hydrochloride compared with 100 mg of bupivacaine hydrochloride alone (control) administered by periarticular injection at the time of surgery. Main Outcome and Measures: The coprimary outcomes were Quality of Recovery 40 (QoR-40) score at 72 hours and pain visual analog scale (VAS) score area under the curve (AUC) from 6 to 72 hours. Secondary outcomes included QoR-40 and mean pain VAS at days 0 (evening of surgery), 1, 2, and 3; cumulative opioid consumption for 72 hours; functional outcomes and quality of life at 6 weeks, 6 months, and 1 year; and cost-effectiveness for 1 year. Adverse events and serious adverse events up to 12 months after randomization were also assessed. Results: Among the 533 participants included in the analysis, the mean (SD) age was 69.0 (9.7) years; 287 patients were women (53.8%) and 246 were men (46.2%). Baseline characteristics were balanced between study groups. There was no difference between the liposomal bupivacaine and control groups in QoR-40 score at 72 hours (adjusted mean difference, 0.54 [97.5% CI, -2.05 to 3.13]; P = .64) or the pain VAS score AUC at 6 to 72 hours (-21.5 [97.5% CI, -46.8 to 3.8]; P = .06). Analyses of pain VAS and QoR-40 scores demonstrated only 1 statistically significant difference, with the liposomal bupivacaine arm having lower pain scores the evening of surgery (adjusted difference -0.54 [97.5% CI, -1.07 to -0.02]; P = .02). No difference in cumulative opioid consumption and functional outcomes was detected. Liposomal bupivacaine was not cost-effective compared with the control treatment. No difference in adverse or serious adverse events was found between the liposomal bupivacaine and control groups. Conclusions and Relevance: This study found no difference in postoperative recovery or pain associated with the use of periarticular liposomal bupivacaine compared with bupivacaine hydrochloride alone in patients who underwent knee replacement surgery. Trial Registration: isrctn.com Identifier: ISRCTN54191675.

Primary stability of a proximally coated and tapered stem.

AIMS: The aim of this prospective cohort study was to evaluate the early migration of the TriFit cementless proximally coated tapered femoral stem using radiostereometric analysis (RSA). METHODS: A total of 21 patients (eight men and 13 women) undergoing primary total hip arthroplasty (THA) for osteoarthritis of the hip were recruited in this study and followed up for two years. Two patients were lost to follow-up. All patients received a TriFit stem and Trinity Cup with a vitamin E-infused highly cross-linked ultra-high molecular weight polyethylene liner. Radiographs for RSA were taken postoperatively and then at three, 12, and 24 months. Oxford Hip Score (OHS), EuroQol five-dimension questionnaire (EQ-5D), and adverse events were reported. RESULTS: At two years, the mean subsidence of the head and tip for the TriFit stem was 0.38 mm (SD 0.32) and 0.52 mm (SD 0.36), respectively. The total migration of the head and tip was 0.55 mm (SD 0.32) and 0.71 mm (SD 0.38), respectively. There were no statistically significant differences between the three to 12 months' migration (p = 0.105) and 12 to 24 months' migration (p = 0.694). The OHS and EQ-5D showed significant improvements at two years. CONCLUSION: The results of this study suggest that the TriFit femoral stem achieves initial stability and is likely to be stable in the mid and long term. A long-term outcome study is required to assess late mechanisms of failure and the effects of bone mineral density (BMD) related changes. Cite this article: Bone Joint J 2021;103-B(4):644-649.

Development of a patient-reported outcome measure (PROM) and change measure for use in early recovery following hip or knee replacement.

BACKGROUND: Hip and knee replacement are effective procedures for end-stage arthritis that has not responded to medical management. However, until now, there have been no validated, patient-reported tools to measure early recovery in this growing patient population. The process of development and psychometric evaluation of the Oxford Arthroplasty Early Recovery Score (OARS), a 14-item patient-reported outcome measure (PROM) measuring health status, and the Oxford Arthroplasty Early Change Score (OACS) a 14-item measure to assess change during the first 6 weeks following surgery is reported. PATIENTS AND METHODS: A five-phased, best practice, iterative approach was used. From a literature based starting point, qualitative interviews with orthopaedic healthcare professionals, were then performed ascertaining if and how clinicians would use such a PROM and change measure. Analysis of in-depth patient-interviews in phase one identified important patient-reported factors in early recovery which were used to provide questionnaire themes. In Phase two, candidate items from Phase One interviews were generated and pilot questionnaires developed and tested. Exploratory factor analysis with item reduction and final testing of the questionnaires was performed in phase three. Phase Four involved validation testing. RESULTS: Qualitative interviews (n = 22) with orthopaedic healthcare professionals, helped determine views of potential users, and guide structure. In Phase One, factors from patient interviews (n = 30) were used to find questionnaire themes and generate items. Pilot questionnaires were developed and tested in Phase Two. Items were refined in the context of cognitive debrief interviews (n = 34) for potential inclusion in the final tools. Final testing of questionnaire properties with item reduction (n = 168) was carried out in phase three. Validation of the OARS and OACS was performed in phase four. Both measures were administered to consecutive patients (n = 155) in an independent cohort. Validity and reliability were assessed. Psychometric testing showed positive results, in terms of internal consistency and sensitivity to change, content validity and relevance to patients and clinicians. In addition, these measures have been found to be acceptable to patients throughout early recovery with validation across the 6 week period. CONCLUSIONS: These brief, easy-to-use tools could be of great use in assessing recovery pathways and interventions in arthroplasty surgery.

Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): study protocol for a patient-blinded, randomised controlled superiority trial of liposomal bupivacaine.

BACKGROUND: Optimising the management of peri-operative pain and recovery following knee replacement has been identified as a patient priority. Current pain relief strategies use opiate-based analgesia; however, up to 50% of patients experience significant side effects. Local anaesthetic incisional infiltration is one alternative. The length of the duration of action is a major limiting factor of current local anaesthetic techniques. Liposomal bupivacaine has been reported to be effective for up to 72 h. This randomised controlled trial will evaluate the clinical and cost effectiveness of liposomal bupivacaine. METHODS: SPAARK is a patient-blinded, multi-centre, active comparator, superiority, two-arm, parallel-group randomised controlled trial. Five hundred patients undergoing knee replacement will be recruited and randomised to liposomal bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone. The co-primary outcomes are the Quality of Recovery 40 measured at 72 h post-surgery and also cumulative pain measured daily using a 0-10 visual analogue scale for the first 3 days following surgery. Secondary outcomes include cumulative opioid consumption, fitness for discharge, functional outcomes assessed using the Oxford Knee Score and American Knee Society Score, the EuroQol five dimensions instrument and complications. A cost utility analysis is also planned. DISCUSSION: The clinical effectiveness and cost effectiveness of liposomal bupivacaine have yet to be evaluated in the National Health Service, making this trial appropriate and timely. TRIAL REGISTRATION: ISRCTN registry, ISRCTN54191675. Registered on 14 November 2017.

Perioperative adjuvant corticosteroids for post-operative analgesia in elective knee surgery - A systematic review.

BACKGROUND: Elective knee surgery is performed to reduce chronic pain and improve function in degenerate knees. Treatment of acute post-operative pain is suboptimal in 75% of patients despite multimodal analgesic approaches resulting in higher post-operative opiate consumption. The effect of corticosteroids as an adjunct for post-operative pain control remains undefined. METHODS: The databases MEDLINE, EMBASE and CENTRAL (Cochrane library) will be searched from their inception to present using broad search criteria for eligible randomised/quasi-randomised controlled trials investigating perioperative corticosteroid adjunctive use in elective knee surgery. Meta-analyses will be conducted according to the recommendations from the Cochrane Handbook for Systematic Reviews of Interventions. DISCUSSION: This systematic review of the perioperative adjunctive use of corticosteroids will assess the analgesic effects, post-operative nausea and vomiting, opiate consumption, infection rates and time till discharge and assess whether adjunctive corticosteroids should be encouraged in elective knee surgery. SYSTEMATIC REVIEW REGISTRATION: PROPSERO CRD42016049336.

A Meta-Analysis on the Use of Gabapentinoids for the Treatment of Acute Postoperative Pain Following Total Knee Arthroplasty.

BACKGROUND: Total knee arthroplasty is a painful procedure, with approximately half of patients reporting severe pain during the early postoperative period. Gabapentinoids are used as an adjunct for the management of acute pain in approximately half of enhanced recovery programs. We performed a meta-analysis to assess the effectiveness and safety of gabapentinoids for the treatment of acute postoperative pain following total knee arthroplasty. METHODS: Randomized controlled trials of patients undergoing elective primary total knee arthroplasty that compared the use of the gabapentinoid class of drugs (gabapentin [Neurontin; Pfizer]) or pregabalin [Lyrica; Pfizer]) with that of placebo were retrieved, with 12 studies meeting inclusion criteria. The primary outcome was pain intensity with activity at 48 hours following the surgical procedure. The secondary outcomes included pain intensity at other time points, opioid consumption, knee function, incidence of chronic pain, and adverse events. RESULTS: No difference in pain score at 12, 24, 48, or 72 hours following the surgical procedure was seen between gabapentin and placebo. Although pregabalin was associated with reduced pain scores at 24 and 48 hours, this corresponded to a reduction of 0.5 point (95% confidence interval, 0 to 1.0 point) at 24 hours and 0.3 point (95% confidence interval, 0 to 0.6 point) at 48 hours on an 11-point numeric rating scale, which was assessed as not clinically important. Overall, no clinically relevant reduction in pain scores was associated with the use of gabapentinoids. Likewise, gabapentinoids were associated with a small, but not clinically important, reduction in cumulative opioid consumption at 48 hours (mean difference, -23.2 mg [95% confidence interval, -40.9 to -5.4 mg]). There was no difference in knee flexion at 48 hours (p = 0.63) or in the incidence of chronic pain at 3 months (p = 0.31) or 6 months (p = 0.54) associated with the use of gabapentinoids. Although gabapentinoids were associated with a significant reduction in the incidence of nausea (risk ratio, 0.7 [95% confidence interval, 0.6 to 0.9]; p < 0.001), pregabalin was also associated with a significant, clinically relevant increase in the risk of sedation (risk ratio, 1.4 [95% confidence interval, 1.1 to 1.9]; p = 0.02). CONCLUSIONS: On the basis of this meta-analysis, we found no evidence to support the routine use of gabapentinoids in the management of acute pain following total knee arthroplasty. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Assessing Arthroscopic Skills Using Wireless Elbow-Worn Motion Sensors.

BACKGROUND: Assessment of surgical skill is a critical component of surgical training. Approaches to assessment remain predominantly subjective, although more objective measures such as Global Rating Scales are in use. This study aimed to validate the use of elbow-worn, wireless, miniaturized motion sensors to assess the technical skill of trainees performing arthroscopic procedures in a simulated environment. METHODS: Thirty participants were divided into three groups on the basis of their surgical experience: novices (n = 15), intermediates (n = 10), and experts (n = 5). All participants performed three standardized tasks on an arthroscopic virtual reality simulator while wearing wireless wrist and elbow motion sensors. Video output was recorded and a validated Global Rating Scale was used to assess performance; dexterity metrics were recorded from the simulator. Finally, live motion data were recorded via Bluetooth from the wireless wrist and elbow motion sensors and custom algorithms produced an arthroscopic performance score. RESULTS: Construct validity was demonstrated for all tasks, with Global Rating Scale scores and virtual reality output metrics showing significant differences between novices, intermediates, and experts (p < 0.001). The correlation of the virtual reality path length to the number of hand movements calculated from the wireless sensors was very high (p < 0.001). A comparison of the arthroscopic performance score levels with virtual reality output metrics also showed highly significant differences (p < 0.01). Comparisons of the arthroscopic performance score levels with the Global Rating Scale scores showed strong and highly significant correlations (p < 0.001) for both sensor locations, but those of the elbow-worn sensors were stronger and more significant (p < 0.001) than those of the wrist-worn sensors. CONCLUSIONS: A new wireless assessment of surgical performance system for objective assessment of surgical skills has proven valid for assessing arthroscopic skills. The elbow-worn sensors were shown to achieve an accurate assessment of surgical dexterity and performance. CLINICAL RELEVANCE: The validation of an entirely objective assessment of arthroscopic skill with wireless elbow-worn motion sensors introduces, for the first time, a feasible assessment system for the live operating theater with the added potential to be applied to other surgical and interventional specialties.