Lower Risk of Revision With 32- and 36-Millimeter Femoral Heads Compared With 28-mm Heads in Primary Total Hip Arthroplasty: A Comparative Single-Center Study (10,104 Hips).

BACKGROUND: We aimed to compare the clinical outcomes of different head sizes (28-, 32-, and 36- millimeter) in primary total hip arthroplasty (THA) at mean 6 years follow-up (range, 1 to 17.5 years). METHODS: This was a retrospective consecutive study of primary THA at our institution (2003 to 2019). Demographic and surgical data were collected. The primary outcome measures were all-cause revision, revision for dislocation, and all-cause revision excluding dislocation. Continuous descriptive statistics used means, median values, ranges, and 95% confidence intervals, where appropriate. Kaplan-Meier survival curves were used to estimate time to revision. Cox proportional hazard regression analyses were used to compare revision rates between the femoral head size groups. Adjustments were made for age at surgery, sex, primary diagnosis, American Society of Anesthesiologists score, articulation type, and fixation methods. There were 10,104 primary THAs included; median age was 69 years (range, 13 to 101) with 61.5% women. A posterior approach was performed in 71.6%. There were 3,295 hips with 28-mm heads (32.6%), 4,858 (48.1%) with 32-mm heads, and 1,951 (19.3%) with 36-mm heads. RESULTS: Overall rate of revision was 1.7% with the lowest rate recorded for the 36-mm group (2.7 versus 1.3 versus 1.1%). Cox regression analyses showed a decreased risk of all-cause revision for 32 and 36-mm head sizes as compared to 28-mm; this was statistically significant for the 32-mm group (P = .01). Risk of revision for dislocation was significantly reduced in both 32-mm (P = .03) and 36-mm (P = .03) head sizes. Analysis of all cause revision excluding dislocation showed no significant differences between head sizes. CONCLUSIONS: We found a significantly reduced risk of revision for all causes, but particularly revision for dislocation with larger head sizes. Concerns regarding increased risk of early revision for aseptic loosening, polyethylene wear, or taper corrosion with larger heads appear to be unfounded in this cohort of 10,104 patients with up to 17 years follow-up.

Return to driving post upper or lower extremity orthopaedic surgical procedures: a scoping review of current published literature.

Patients undergoing planned or unplanned orthopaedic procedures involving their upper or lower extremity can prevent them from safe and timely return to driving, where they commonly ask, 'Doctor, when can I drive?' Driving recommendations after such procedures are varied. The current evidence available is based on a heterogenous data set with varying degrees of sample size and markedly differing study designs. This instructional review article provides a scoping overview of studies looking at return to driving after upper or lower extremity surgery in both trauma and elective settings and, where possible, to provide clinical recommendations for return to driving. Medline, EMBASE, SCOPUS, and Web of Science databases were searched according to a defined search protocol to elicit eligible studies. Articles were included if they reviewed adult drivers who underwent upper or lower extremity orthopaedic procedures, were written in English, and offered recommendations about driving. A total of 68 articles were included in the analysis, with 36 assessing the lower extremity and 37 reviewing the upper extremity. The evidence available from the studies reviewed was of poor methodological quality. There was a lack of adequately powered, high quality, randomised controlled trials (RCTs) with large sample sizes to assess safe return to driving for differing subset of injuries. Many articles provide generic guidelines on return to driving when patients feel safe to perform an emergency stop procedure with adequate steering wheel control. In future, RCTs should be performed to develop definitive return to driving protocols in patients undergoing upper and lower extremity procedures.

"Wearable Sensors to Guide Remote Rehabilitation Following Knee Arthroplasty Surgery".

Background: Total knee arthroplasty requires effective rehabilitation to achieve optimal results, but institutions often rely on unsupervised home exercises due to cost constraints. Wearable sensors have become increasingly popular as a potential method of monitoring patients remotely to ensure efficacy and compliance. This review assesses the current evidence for their use in remotely monitored rehabilitation following knee arthroplasty. Methods: A systematic review of the literature from 1st January 2000 to 17th February 2022 was undertaken. Devices were categorised as joint-specific or physical activity sensors. Studies were classified as those providing remotely supervised rehabilitation as an additional or as an alternative intervention. Results: Remotely supervised rehabilitation using wearable sensors demonstrated similar outcomes when provided as an alternative to standard care in most studies. One group found improved outcomes for knee-specific sensors compared with standard care. There were improved physical activity and healthcare resource use outcomes described in the literature where sensors were used in addition to standard care. Discussion: This review found evidence for the use of wearable sensors in remotely supervised rehabilitation following knee arthroplasty surgery. This included methodological heterogeneity, differing definitions of standard care, and variable follow-up periods. Robust randomised control trial data with a longer follow-up period are needed.

"Smart Knee Implants: An Overview of Current Technologies and Future Possibilities".

Background: This article focuses on clinical implementation of smart knee implants for total knee replacement and the future development of smart implant technology. With the number of total knee replacements undertaken growing worldwide, smart implants incorporating embedded sensor technology offer opportunity to improve post-operative recovery, reducing implant failure rates, and increasing overall patient satisfaction. Methods: A literature review on smart implants, historical prototypes, current clinically available smart implants, and the future potential for conventional implant instrumentation with embedded sensors and electronics was undertaken. Results: The overview of current and future technology describes use cases for various diagnostic and therapeutic treatment solutions. Conclusion: Smart knee implants are at an early development stage, with the first generation of smart implants being available to patients and with more novel technologies under development.

Doctor when can I drive? A systematic review and meta-analysis of return to driving after total hip arthroplasty.

BACKGROUND/OBJECTIVE: Advice given to patients on driving resumption after total hip arthroplasty (THA) is inconsistent. Due to a lack of clear guidelines, surgeons' recommendations range between 4-8 weeks after surgery to resume driving. Delays in driving return can have detrimental social and economic impact. However, it is important to ensure patients only resume driving once safe. This study presents a systematic review and meta-analysis of driving simulation studies after THA to establish when patients can safely return to driving postoperatively. METHODS: A systematic review and meta-analysis using PRISMA guidelines was undertaken. Titles and abstracts were screened for inclusion, data was extracted, and studies assessed for bias risk. Review Manager, was used for statistical analysis. Values for brake reaction time (BRT) were included for meta-analysis. RESULTS: 14 articles met the inclusion criteria. Of these, 7 measured BRT and were included in the meta-analysis. Pooled means of both right and left THA showed BRT around or above preoperative baseline at 1 week, 2 weeks and 3 weeks, and below baseline at 6 weeks, 12 weeks, 32 weeks and 52 weeks. Of these, the pooled means at 6, 32, and 52 weeks were significant (p < 0.05).Studies not meeting meta-analysis inclusion criteria were included in a qualitative analysis, examining self-reported postoperative driving return times which ranged from 6 days to over a year or in rare cases, never. Majority of patients (n = 960) self-reported driving return within approximately 6 weeks (pooling of mean values 32.9 days). CONCLUSIONS: The mean return to driving time recommended in the literature was 4.5 weeks. Based upon BRT meta-analysis, a return to baseline braking performance was noted at 6 weeks postoperatively. However, driving is a complex skill, and patient recommendation should be individualised based on factors such as vehicle transmission type, THA technique, surgical side, medication and comorbidities.

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.

The Effect of Perioperative Biologic Disease-Modifying Anti-Rheumatic Drugs on the Risk of Postoperative Complications: Surgical Site Infection, Delayed Wound Healing, and Disease Flares Following Orthopaedic Surgical Procedures.

BACKGROUND: Biologic disease-modifying anti-rheumatic drugs (bDMARDs) are effective in treating inflammatory diseases and have been increasingly utilized over the past decade. Patients who receive bDMARDs have been shown to be at an increased risk for surgical site infection following surgical procedures. The severe consequences of infection following orthopaedic surgery have led to the practice of withholding bDMARDs perioperatively; however, there has been no definitive evidence showing a clear benefit of withholding the use of bDMARDs, and in doing so, patients may be at an increased risk for higher disease activity. As such, the purpose of the present study was to compare the risk of infection, delayed wound healing, and disease flares associated with the use of bDMARDs in patients undergoing orthopaedic surgical procedures. METHODS: We performed a systematic literature search of MEDLINE, Embase, and PubMed CENTRAL databases for studies comparing continuing and withholding the use of bDMARDs in patients undergoing orthopaedic procedures. Inclusion criteria were established following the PICO (Population, Intervention, Comparison, and Outcomes) approach: Population = patients who underwent orthopaedic surgical procedures and who were taking bDMARDs. Intervention = withholding the use of bDMARDs. Comparator = continuing the use of bDMARDs. Outcomes = surgical site infection, delayed wound healing, and disease flares. Article titles and abstracts were screened prior to review of the full text. Overall odds ratios (ORs) and associated 95% confidence intervals (CIs) for pooled effects were calculated. RESULTS: Eleven studies met the inclusion criteria, providing data for 7,344 patients, including 2,385 patients who continued and 4,959 who withheld their bDMARDs perioperatively. Continuing bDMARDs was associated with a significantly lower risk of disease flares (OR, 0.22; 95% CI, 0.05 to 0.95; p = 0.04) and nonsignificant increases in surgical site infections (OR, 1.11; 95% CI, 0.82 to 1.49; p = 0.49) and wound complications (OR, 2.16; 95% CI, 0.48 to 9.85; p = 0.32). CONCLUSIONS: The present systematic review highlights the limited evidence supporting the current practice of stopping bDMARDs perioperatively. These findings suggest that patients may not be at an increased risk for developing infection or wound complications if bDMARDs are continued but are at an increased risk for disease flare if bDMARDs are withheld. However, our conclusions are limited by the retrospective and heterogenous nature of the data, and possibly by a lack of study power. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Can the use of an inclinometer improve acetabular cup inclination in total hip arthroplasty? A review of the literature.

INTRODUCTION: The angle of acetabular (cup) radiographic inclination is an important measurement in total hip arthroplasty (THA) procedures. Abnormal radiographic inclination is associated with dislocation, edge loading and higher failure rates. Consistently achieving a satisfactory radiographic inclination remains a challenge. Inclinometers have been increasingly used over the last decade. This paper reviews the literature to determine whether using an inclinometer improves the accuracy of acetabular cup inclination in THA. METHODS: A systematic literature search was performed. The following search terms were used: ('hip' OR 'hip replacement' OR 'hip arthroplasty' OR 'primary hip replacement' OR 'THR' OR 'THA' OR 'Acetabular cup Inclination') AND ('Inclinometer'). Titles and abstracts were screened for relevance. Both radiographic and operative inclination comparisons were included. RESULTS: 7 studies met the inclusion criteria. 2 were randomised control trials with level I evidence, and the remaining studies were cohort studies with level III/IV evidence. 5 were clinical and 2 experimental. In total there were 16 cohorts: 7 using an inclinometer, 6 freehand, and 3 using MAG techniques. All studies comparing radiographic inclination and 1 of 2 studies comparing operative inclination showed an improvement in the attainment of the optimal inclination. Similarly, the use of an inclinometer showed a reduction in the number of outliers when compared to MAG and freehand techniques. DISCUSSION: This review demonstrates that using an inclinometer improved the surgeon's ability to achieve their intended inclination (both operative and radiographic) and reduced the incidence of positioning outside the safe-zone. However, only 2 of the studies were randomised control trials and these resulted in opposing conclusions. Therefore, further studies looking at the use of inclinometers would prove useful in understanding their true benefit.

How Accurate is the Use of Contralateral Implant Size as a Template in Bilateral Hemiarthroplasty?

PURPOSE: Accurately predicting implant size for hemiarthroplasties offers an important contribution to theatre efficiency and patients' intraoperative care. However, pre-operative sizing using templating of implants in hip fracture patients requiring a hemiarthroplasty is often difficult due to non-standard radiographs, absence of a calibration marker, poor marker placement, variable patient position, and in many institutions a lack of templating facilities. In patients who have previously undergone a hemiarthroplasty on the contralateral side, surgeons can use the contralateral implant size for pre-operative planning purposes. However, the accuracy of doing this has not previously been reported. The aim of this study was to investigate the reliability of using an in situ contralateral implant as a predictor of implant size on the contralateral side. METHODS: A retrospective review of our local neck of femur fracture (NOF) database was undertaken to identify patients who had bilateral hip hemiarthroplasty. Operative records were reviewed to establish the size of prostheses used at operation. Correlation, agreement, and reliability analysis were performed using the least squares, Bland-Altman plot, and intra-class correlation coefficient (ICC) methods, respectively. RESULTS: Operative records were identified for 45 patients who had bilateral hemiarthroplasties. There was a difference in implant size used in 58% of cases. Of these 77% required a larger implant on the right. Implant sizes were within 1 mm of the contralateral side in 78% and within 2 mm in 91% of patients. However, in 9% of patients, there was a discrepancy greater than 2 mm with some cases having up to 6 mm discrepancy. Correlation coefficient was 0.83 and the ICC 0.90. CONCLUSIONS: The findings in this study indicated that using the size of a contralateral implant can be used as a reliable indicator of head size in cases of bilateral hemiarthroplasty. However, the surgeon should remain cautious as there is a one in ten chance of there being a 3 mm or more difference in implant size.

Changing Device Regulations in the European Union: Impact on Research, Innovation and Clinical Practice.

BACKGROUND: Up until 2017, medical devices were placed on the European Union's (EU) single market in accordance with either Medical Device Directive 93/42/EEC for general medical devices or Medical Device Directive 90/385/EEC for active implantable devices. However, some devices that complied with these directives still failed catastrophically. In the orthopaedic device field, these failures were most pronounced in metal-on-metal hip devices causing severe patient morbidity with increased need for revision surgery which had unpredictable outcomes. Subsequently, the newly introduced Medical Device Regulations 2017/745 are aimed at addressing patient safety based on previous experience and thorough device assessment prior to and post-release on the EU single market; to accommodate for this they are substantially different (and more stringent). This poses a greater challenge for manufacturers and regulatory bodies in terms of time and resources. METHODS: A review of the EU directives and published literature was undertaken. This review provides the rationale behind this change and its potential impact on research, industry, and clinical practice. DISCUSSION: The change in legal requirements for the medical devices to be put on the EU single market ultimately leads to increased patient safety, which is supported by clinical professionals. The new requirements for data transparency, post-market surveillance, and implant information availability increase the chance of catastrophic failure prevention. However, the exact method of implementation remains uncertain, and some essential rules on the data requirements for compliance have not yet been published by the EU. These limitations may limit the availability of products on the market including withdrawal of existing devices and a decrease in new medical device innovation. It is speculated that lack of new technologies within the medical device area can dramatically affect patient safety itself by not allowing potentially safer materials and methods on the EU single market, as the focus for the manufacturer becomes existing devices.

Training and Transfer Effect of FluoroSim, an Augmented Reality Fluoroscopic Simulator for Dynamic Hip Screw Guidewire Insertion: A Single-Blinded Randomized Controlled Trial.

BACKGROUND: FluoroSim, a novel fluoroscopic simulator, can be used to practice dynamic hip screw (DHS) guidewire insertion in a high-fidelity clinical scenario. Our aim was to demonstrate a training effect in undergraduate medical students who are not familiar with this operation and its simulation. METHODS: Forty-five undergraduate medical students were recruited and randomized to either training (n = 23) or control (n = 22) cohorts. The training cohort had more exposure to FluoroSim (5 attempts each week) over a 2-week period (with a 1-week washout period in between) compared with the control cohort (a single attempt 1 week apart) over a 2-week period. Five real-time objective performance metrics were recorded: (1) tip-apex distance (TAD) (mm), (2) predicted cut-out rate (%), (3) total procedural time (sec), (4) total number of radiographs (n), and (5) total number of guidewire retries (n). RESULTS: At baseline, there was no significant difference in the performance metrics, which confirmed the absence of a selection bias. The intragroup training effect demonstrated a significant improvement in all metrics for the training cohort only. A significant difference between groups was demonstrated as the training cohort significantly outperformed the control cohort in 3 metrics (procedural time [25%], number of radiographs [57%], and number of guidewire retries [100%]; p < 0.001). A learning curve showed an inversely proportional correlation between frequency of attempts and procedural time as well as the number of digital fluoroscopic radiographs that were made, indicating the development of psychomotor skills. There was also an improved baseline of the learning curve after the 1-week washout period, suggesting skill retention. CONCLUSIONS: Skill acquisition with the FluoroSim system was demonstrated with repeat exposure in a safe, radiation-free high-fidelity clinical simulation with actual operating room equipment. The task of DHS guidewire insertion requires cognitive and psychomotor skills that take a variable number of attempts to acquire, as demonstrated on the learning curve. Additional work is required to demonstrate that the skill tested by the FluoroSim is the same skill that is required for intraoperative DHS guidewire insertion. However, use of the FluoroSim provides improvement in skills with extra-clinical training opportunities for orthopaedic trainees. CLINICAL RELEVANCE: FluoroSim has demonstrated validity and training effect. It has the potential to be approved for possible use on patients in the operating room to help surgeons with the operation. Consequently, operating time, accuracy of TAD, and surgical outcomes may all be improved.

Posterior Bearing Overhang Following Medial and Lateral Mobile Bearing Unicompartmental Knee Replacements.

This study explores the extent of bearing overhang following mobile bearing Oxford unicompartmental knee replacement (OUKR) (Oxford Phase 3, Zimmer Biomet). The Oxford components are designed to be fully congruent, however knee movements involve femoral rollback, which may result in bearing overhang at the posterior margin of the tibial implant, with potential implications for; pain, wear, and dislocation. Movement is known to be greater, and therefore posterior overhang more likely to occur, with; lateral compared to medial implants, anterior cruciate ligament (ACL) deficiency (ACLD) compared to ACL intact (ALCI), and at extremes of movement. Twenty-four medial, and 20 domed lateral, OUKRs underwent sagittal plane knee fluoroscopy during step-up and forward lunge exercises. The bearing position was inferred from the relative position of the femoral and tibial components. On the basis of the individual component sizes and geometry the extent the posterior part of the bearing which overhung the posterior part of the tibial component was calculated. There was no significant posterior overhang in knees with medial implants. Knees with lateral domed implants exhibited overhang at flexion angles beyond 60°, the magnitude of which increased with increasing flexion angle, reaching a maximum of 50% of the bearing length at 140° (range 0-140°). This demonstrates a clear difference between the kinematics, and prevalence and extent of posterior bearing overhang between medial and lateral OUKRs. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 37:1938-1945, 2019.

Teaching basic trauma: validating FluoroSim, a digital fluoroscopic simulator for guide-wire insertion in hip surgery.

Background and purpose - Simulation is an adjunct to surgical education. However, nothing can accurately simulate fluoroscopic procedures in orthopedic trauma. Current options for training with fluoroscopy are either intraoperative, which risks radiation, or use of expensive and unrealistic virtual reality simulators. We introduce FluoroSim, an inexpensive digital fluoroscopy simulator without the need for radiation. Patients and methods - This was a multicenter study with 26 surgeons in which everyone completed 1 attempt at inserting a guide-wire into a femoral dry bone using surgical equipment and FluoroSim. 5 objective performance metrics were recorded in real-time to assess construct validity. The surgeons were categorized based on the number of dynamic hip screws (DHS) performed: novices (< 10), intermediates (10-39) and experts (≥ 40). A 7-point Likert scale questionnaire assessed the face and content validity of FluoroSim. Results - Construct validity was present for 2 clinically validated metrics in DHS surgery. Experts and intermediates statistically significantly outperformed novices for tip-apex distance and for cut-out rate. Novices took the least number of radiographs. Face and content validity were also observed. Interpretation - FluoroSim discriminated between novice and intermediate or expert surgeons based on tip-apex distance and cut-out rate while demonstrating face and content validity. FluoroSim provides a useful adjunct to orthopedic training. Our findings concur with results from studies using other simulation modalities. FluoroSim can be implemented for education easily and cheaply away from theater in a safe and controlled environment.

Patients' and health-care professionals' awareness of cost: a multicentre survey.

Delivering cost-effective health care within the constraints of public funding is the goal of the NHS. In this study 248 health-care professionals and patients across six different hospitals were surveyed to ascertain their cost awareness. Cost awareness was poor across all groups.

Sagittal kinematics of mobile unicompartmental knee replacement in anterior cruciate ligament deficient knees.

BACKGROUND: There is a greater risk of tibial component loosening when mobile unicompartmental knee replacement is performed in anterior cruciate ligament deficient knees. We previously reported on a cohort of anterior cruciate ligament deficient patients (n=46) who had undergone surgery, but no difference was found in implant survivorship at a mean 5-year follow-up. The purpose of this study was to examine the kinematic behaviour of a subcohort of these patients. METHODS: The kinematic behaviour of anterior cruciate deficient knees (n=16) after mobile unicompartmental knee replacement was compared to matched intact knees (n=16). Sagittal plane knee fluoroscopy was taken while patients performed step-up and forward lunge exercises. The patellar tendon angle, knee flexion angle and implant position was calculated for each video frame. FINDINGS: The patellar tendon angle was 5° lower in the deficient group, indicating greater anterior tibial translation compared to the intact group between 30 and 40° of flexion. Large variability, particularly from 40-60° of flexion, was observed in the bearing position of the deficient group, which may represent different coping mechanisms. The deficient group took 38% longer to perform the exercises. INTERPRETATION: Kinematic differences were found between the deficient and intact knees after mobile unicompartmental knee replacement; but these kinematic changes do not seem to affect the medium-term clinical outcome. Whether these altered knee kinematics will have a clinical impact is as yet undetermined, but more long-term outcome data is required before mobile unicompartmental knee replacement can be recommended for an anterior cruciate ligament deficient patient.