The influence of implant factors on patient outcomes in primary total knee arthroplasty.

Background: The influence of implant factors on patient-reported outcome measures (PROMS) after total knee arthroplasty (TKA) has previously been studied but findings are often inconsistent, restricted in scope and biased by confounding factors. This study aims to determine the association between implant-related factors and early post-operative PROMs after TKA. Methods: Using data from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) PROMs program, the study included 9487 primary TKA procedures performed in 43 hospitals from July 31, 2018 to December 31, 2020. Data included baseline demographic data, surgical details and PROMs collected pre- and 6 months post-operatively. Seven prosthesis characteristics were incorporated in the multivariable model, with proportional odds ordinal regression analysis used to assess their effects on post-operative Oxford knee score (OKS) and joint pain. Adjustments were made for pre-operative OKS and joint pain, as well as potential patient confounders. Results: At six months, fixed bearing implants showed higher odds of better OKS compared to mobile bearing implants (odds ratio [OR] = 1.20, 95 % confidence interval [CI] 1.06-1.37. p < 0.004). Similar findings were found with the use of image derived instrumentation (IDI) (OR = 1.27, 95 % CI 1.11-1.46, p < 0.001), robotic assisted vs. non-navigated knees (OR = 1.21, 95 % CI 1.06-1.38, p < 0.005) and no patella resurfacing (OR = 1.10, 95 % CI 1.01-1.20, p < 0.032). For lower pain scores at six months, the use of highly crosslinked polyethylene (OR = 1.12, 95 % CI 1.02-1.22, p < 0.015), cemented femoral components (OR = 1.11, 95 % CI 1.01-1.22, p < 0.024), IDI (OR = 1.20, 95 % CI 1.05-1.37, p < 0.009) or no patella resurfacing (OR = 1.10, 95 % CI 1.01-1.20, p < 0.034) were associated. Conclusion: Utilizing a fixed bearing or robotic assistance correlated with improved OKS scores, whereas highly crosslinked polyethylene or cemented femoral components were associated with improved pain scores. At six months, the use of IDI compared to non-navigated TKA, and patellar resurfacing showed both improved OKS and pain scores.

Trends in diagnosis, referral, red flag onset, patient profiles and natural outcome of de novo cardiac amyloidosis and their multidisciplinary implications.

BACKGROUND: Cardiac amyloidosis (CA) is often overlooked or misdiagnosed. Effects of growing disease awareness, diagnostic ameliorations and novel treatment options on CA diagnosis and management are scarcely reported. OBJECTIVE: To report trends in diagnosis, referral routes, clinical presentation, early onset diagnostic red flags and outcome in de novo CA subjects. METHODS: An unselected cohort of 139 de novo CA patients over an 8-year period in a tertiary referral hospital was recruited. RESULTS: Transthyretin (ATTR, 82%, n = 114) was the most common CA form; Light-chain (AL, 15%, n = 21) and secondary (AA, 3%, n = 4) are less prevalent. Increased awareness over time led to a marked ATTR diagnostic surge, steep non-invasive diagnostic approach increment and increased nuclear medicine and external cardiologist referrals (all p < 0.001). A total of 41% (n = 57/139) of patients were referred by non-cardiology specialist disciplines. Specific referral to rule out CA (24-36%) and diagnostic time lag from symptom onset (9 ± 12 to 8 ± 14 months), however, did not improve (all p > 0.050). Multiple early red flag events preceded CA diagnose several years in ATTR: Left ventricular hypertrophy (LVH, 60%, 4.9 ± 4.3 y), heart failure (54%, 2.5 ± 3.5 y), atrial fibrillation (47%, 5.9 ± 6.7 y), bilateral carpal tunnel syndrome (43%, 9.5 ± 5.7 y) and spinal stenosis (40%, 7.4 ± 6.5 y). LVH ≥ 12 mm was absent in 11% ATTR (n = 13/114) and 5% AL (n = 1/21) patients. Hypertension was common in both ATTR (n = 70/114, 62%) and AL (n = 10/21, 48%). 56% (n = 78/139) of CA presented with heart failure. Cumulative 1 and 5-year mortality of 10%/66%, 40%/52% and 75%/75% for ATTR, AL, and AA, respectively, remains high. CONCLUSIONS: Although CA diagnostic uptake and referral improve, specialist-specific disease and diagnostic red flag ignorance result in non-timely diagnosis and unfavourable outcome.

Predicting dissatisfaction following total hip arthroplasty using a Bayesian model averaging approach: Results from the Australian Arthroplasty Clinical Outcomes Registry National (ACORN).

BACKGROUND: Total hip arthroplasty (THA) provides excellent pain relief and improved function in patients with painful arthritis. The aim of this study was to identify rates and predictors of dissatisfaction following THA. METHODS: Data were collected prospectively from the Australian Arthroplasty Clinical Outcomes Registry National (ACORN) database between 2014 and 2016 from 2096 patients who underwent THA. Data included baseline demographics, patient-reported outcome measures (PROMs) and postoperative clinical outcomes. Patients were dichotomized into two groups based on their 6-month response to the satisfaction question answered on a Likert scale. Eighteen predefined variables were analyzed. PROMs included full Oxford Hip Score, EQ-5D, and patient satisfaction. A Bayesian model averaging approach was used to build the best predictive model for dissatisfaction. Multiple logistic regression techniques were applied to quantify the effect size of the best model. RESULTS: At 6 months following THA, 95.4% of patients (n = 2000) were satisfied with surgical outcome and 4.6% (n = 96) were dissatisfied. The only variable that was significantly associated with dissatisfaction after THA was "complications after discharge." This result was consistent for both the complete and imputed dataset (odds ratio 4.78, 95% confidence interval 2.60-8.80, P < 0.001 and odds ratio 3.8, 95% confidence interval 2.60-5.60, P < 0.001, respectively). CONCLUSION: Our study confirms the high rates of patient satisfaction following THA, with postoperative complications being the only determinant of dissatisfaction. Optimization of patients prior to surgery, reducing postoperative complications, may further improve satisfaction rates after THA.

Fracture risk during extraction of well-fixed extended cementless stems : porous versus hydroxyapatite coated.

The concern of extensive fracturing and bone damage during implant removal has been reported for ingrowing stems, in particular in extended porous coated stems, potentially impeding successful re- implantation of a femoral revision implant and consequently debilitating patients for life. The aim of the present study is to describe this particular complication and comparing the occurrence in porous coated and hydroxyapatite (HA) coated femoral implants. 62 consecutive revision hip replacements were per- formed between January 2010 and December 2016 at a single academic institution. Only revisions of a primary total hip replacement were included. All surgeries were performed by the same senior surgeon. Clinical follow-up involved examination with the Harris hip score (HHS) at 2 years post surgical intervention. Fracture occurrence and severity were compared between groups by means of the Vancouver classification for intraoperative fractures. Overall, significant higher rates of fracturing were observed in the porous coated group (81.8%, p<0.05) compared to the HA coated group (43.5%, p<0.05). Of these fractures, the majority (72,7%) were B3 fractures. There was a significant difference between the mean HHS in the porous-coated group versus the group with HA coating (mean Harris Hip Scores of 68,45 vs 86,17, p = .004). Surgeons have to be wary with implanting porous coated stems in primary hip arthroplasty, especially in younger patients who have a high likelihood of future revision surgery, due to the catastrophic peri-operative fractures associated with the removal of these stems.

Improvement in Sleep Patterns After Hip and Knee Arthroplasty: A Prospective Study in 780 Patients.

BACKGROUND: This study assessed change in sleep patterns before and after total hip arthroplasty (THA) and total knee arthroplasty (TKA) and its relationship to patient-reported outcome measures (PROMs). METHODS: Between July 2016 and June 2018, surgical data and PROMs were collected on 780 subjects before and 12 months after THA or TKA. PROMs included Knee Injury and Osteoarthritis Outcome Score, Hip Disability and Osteoarthritis Outcome Score, patient satisfaction, and 2 questions from the Pittsburgh Sleep Quality Index. RESULTS: Before surgery, 35% (270 of 780) reported poor quality sleep. Sleep quality and duration were worse in females over males, and in THA patients (39%) over TKA patients (30%; P = .011). Of those reporting bad sleep, 74% (201 of 270) were improved after arthroplasty. Satisfaction was higher in subjects reporting good sleep quality (626 of 676; 93%) compared with those reporting bad sleep quality (67 of 86; 78%) (P = .001). Sleep was positively correlated with better Hip Disability and Osteoarthritis Outcome Score/Knee Injury and Osteoarthritis Outcome Score (r = 0.2-0.3). CONCLUSION: Improvement in sleep quality and duration can be expected after THA and TKA and is associated with better outcome scores and satisfaction.

10-year results of the Nesovic procedure combined with adductor release for groin pain in 33 competitive athletes.

The authors present a 10-year review of the postoperative bilateral release of the adductor brevis and gracilis muscles combined with a bilateral abdominal myo-fascio-plasty according to Nesovic for groin pain in competitive athletes. We present the 10 years results of 33 patients operated on between April 2002 and May 2006 diagnosed with a "sports hernia". The injury was treated with a bilateral abdominal procedure according to Nesovic combined with a bilateral adductor release after unsuccessful conservative treatment of at least 2 months. There were 32 male patients between 18 and 43 years and one female patient aged 25 years with a mean age of 28.8 at time of surgery. All procedures were bilateral. Patients were seen in the postoperative clinic and a questionnaire was collected after 2 years and 10 years. Within 16 weeks, 30 patients (90,9 %) returned to the same or a higher level of sports activities. 10 years after surgery 31 patients (93,9%) remained free of pain. 1 patient has minor pain after training (VAS 0-1) and only 1 patient still experiences pain (VAS ≥ 5) after heavy work. 13 patients (39,3%) are still performing sports today, and 19 of 20 patients (95%, 57% of total cohort) were pain free to the end of their sporting careers. The bilateral Nesovic procedure with bilateral adductor release has a high success rate for the competitive athlete with chronic groin pain. It also is a procedure that gave most athletes suffering from a certain type of groin pain a solution till the end of their sporting careers.

A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters.

STUDY DESIGN: Multicenter randomized controlled trial. OBJECTIVE: To compare the efficacy and safety of balloon kyphoplasty (BKP) with nonsurgical management (NSM) during 24 months in patients with painful vertebral compression fractures (VCFs). SUMMARY OF BACKGROUND DATA: Recently, several large randomized controlled trials have been conducted and reported how vertebral augmentation compares with NSM for patients with acute VCFs. Few of these trials report on the surgical aspects and radiographical vertebral deformity results. METHODS: Adults with 1 to 3 VCFs were randomized within 3 months of pain to undergo bilateral BKP (n = 149) or NSM (n = 151). Surgical parameters, subjective quality of life assessments and objective functional (timed up and go) and radiographical assessments were collected. RESULTS: Compared with NSM, the BKP group had greater improvements in SF-36 physical component summary (PCS) scores at 1 month (5.35 points; 95% CI, 3.41-7.30; P < 0.0001) and when averaged across the 24 months (overall treatment effect 2.71 points; 95% CI, 1.34-4.09; P = 0.0001). The kyphoplasty group also had greater functionality by assessing timed up and go (overall treatment effect -2.49 s; 95% CI, -0.82 to -4.15; P = 0.0036). At 24 months, the change in index fracture kyphotic angulation was statistically significantly improved in the kyphoplasty group (average 3.13° of correction for kyphoplasty compared with 0.82° in the control, P = 0.003). Number of baseline prevalent fractures (P = 0.0003) and treatment assignment (P = 0.004) are the most predictive variables for PCS improvement; however, in patients who underwent BKP, there may also be a link with kyphotic angulation. In BKP, the highest quart for kyphotic angulation correction had higher PCS improvement (13.4 points) than the quart having lowest correction of angulation (7.40 points, P = 0.0146 for difference). The most common adverse events temporally related to surgery (i.e., within 30 d) were back pain (20 BKP, 11 NSM) new VCF (11 BKP, 7 NSM), nausea/vomiting (12 BKP, 4 NSM), and urinary tract infection (10 BKP, 3 NSM). Several other adverse events were possibly related to patient positioning in the operating room. CONCLUSION: Compared with NSM, BKP improves patient quality of life and pain averaged during 24 months and results in better improvement of index vertebral body kyphotic angulation. Perioperative complications may be reduced with more care in patient positioning. LEVEL OF EVIDENCE: 2.

Balloon kyphoplasty in patients with osteoporotic vertebral compression fractures.

Balloon kyphoplasty (BKP) is a minimally invasive surgical procedure indicated for treatment of painful vertebral compression fractures. During BKP, cannulae are placed percutaneously into the vertebral body, allowing insertion of inflatable balloons. Inflating the balloons partially restores vertebral body height, compacts the bone and creates a cavity for placement of bone cement after balloon removal. Placement of the cement reduces and stabilizes the fracture. BKP differs from vertebroplasty in that it aims to restore vertebral height and reduce kyphotic deformity. Case reports and observational studies have consistently shown that BKP significantly reduces pain, increases mobility and functional capacity and improves quality of life for up to 3 years. Clinically significant adverse events have been rarely reported. These findings were confirmed in randomized and nonrandomized prospective controlled studies. The objective of this review is to describe the surgical procedures involved in BKP and to review the evidence supporting its use.

Clinical evaluation of the preliminary safety and effectiveness of a minimally invasive interspinous process device APERIUS(®) in degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication.

PURPOSE: New interspinous process decompression devices (IPDs) provide an alternative to conservative treatment and decompressive surgery for patients with neurogenic intermittent claudication (NIC) due to degenerative lumbar spinal stenosis (DLSS). APERIUS(®) is a minimally invasive IPD that can be implanted percutaneously. This multicentre prospective study was designed to make a preliminary evaluation of safety and effectiveness of this IPD up to 12 months post-implantation. METHODS: After percutaneous implantation in 156 patients with NIC due to DLSS, data on symptoms, quality of life, pain, and use of pain medication were obtained for up to 12 months. RESULTS: Early symptom and physical function improvements were maintained for up to 12 months, when 60 and 58 % of patients maintained an improvement higher than the Minimum Clinically Important Difference for Zurich Claudication Questionnaire (ZCQ) symptom severity and physical function, respectively. Leg, buttock/groin, and back pain were eased throughout, and the use and strength of related pain medication were reduced. Devices were removed from 9 % of patients due to complications or lack of effectiveness. CONCLUSIONS: Overall, in a period of up to 12 months follow-up, the safety and effectiveness of the APERIUS(®) offered a minimally invasive option for the relief of NIC complaints in a high proportion of patients. Further studies are underway to provide insight on outcomes and effectiveness compared to other decompression methods, and to develop guidance on optimal patient selection.

Comparing effects of kyphoplasty, vertebroplasty, and non-surgical management in a systematic review of randomized and non-randomized controlled studies.

PURPOSE: To determine if differences in safety or efficacy exist between balloon kyphoplasty (BKP), vertebroplasty (VP) and non-surgical management (NSM) for the treatment of osteoporotic vertebral compression fractures (VCFs). METHODS: As of February 1, 2011, a PubMed search (key words: kyphoplasty, vertebroplasty) resulted in 1,587 articles out of which 27 met basic selection criteria (prospective multiple-arm studies with cohorts of ≥ 20 patients). This systematic review adheres to preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. RESULTS: Pain reduction in both BKP (-5.07/10 points, P < 0.01) and VP (-4.55/10, P < 0.01) was superior to that for NSM (-2.17/10), while no difference was found between BKP/VP (P = 0.35). Subsequent fractures occurred more frequently in the NSM group (22 %) compared with VP (11 %, P = 0.04) and BKP (11 %, P = 0.01). BKP resulted in greater kyphosis reduction than VP (4.8º vs. 1.7°, P < 0.01). Quality of life (QOL) improvement showed superiority of BKP over VP (P = 0.04), along with a trend for disability improvement (P = 0.08). Cement extravasation was less frequent in the BKP (P = 0.01). Surgical intervention within the first 7 weeks yielded greater pain reduction than VCFs treated later. CONCLUSIONS: BKP/VP provided greater pain relief and fewer subsequent fractures than NSM in osteoporotic VCFs. BKP is marginally favored over VP in disability improvement, and significantly favored in QOL improvement. BKP had a lower risk of cement extravasation and resulted in greater kyphosis correction. Despite this analysis being restricted to Level I and II studies, significant heterogeneity suggests that the current literature is delivering inconsistent messages and further trials are needed to delineate confounding variables.

Alternative analyses for handling incomplete follow-up in the intention-to-treat analysis: the randomized controlled trial of balloon kyphoplasty versus non-surgical care for vertebral compression fracture (FREE).

BACKGROUND: Clinical trial participants may be temporarily absent or withdraw from trials, leading to missing data. In intention-to-treat (ITT) analyses, several approaches are used for handling the missing information - complete case (CC) analysis, mixed-effects model (MM) analysis, last observation carried forward (LOCF) and multiple imputation (MI). This report discusses the consequences of applying the CC, LOCF and MI for the ITT analysis of published data (analysed using the MM method) from the Fracture Reduction Evaluation (FREE) trial. METHODS: The FREE trial was a randomised, non-blinded study comparing balloon kyphoplasty with non-surgical care for the treatment of patients with acute painful vertebral fractures. Patients were randomised to treatment (1:1 ratio), and stratified for gender, fracture aetiology, use of bisphosphonates and use of systemic steroids at the time of enrolment. Six outcome measures - Short-form 36 physical component summary (SF-36 PCS) scale, EuroQol 5-Dimension Questionnaire (EQ-5D), Roland-Morris Disability (RMD) score, back pain, number of days with restricted activity in last 2 weeks, and number of days in bed in last 2 weeks - were analysed using four methods for dealing with missing data: CC, LOCF, MM and MI analyses. RESULTS: There were no missing data in baseline covariates values, and only a few missing baseline values in outcome variables. The overall missing-response level increased during follow-up (1 month: 14.5%; 24 months: 28%), corresponding to a mean of 19% missing data during the entire period. Overall patterns of missing response across time were similar for each treatment group. Almost half of all randomised patients were not available for a CC analysis, a maximum of 4% were not included in the LOCF analysis, and all randomised patients were included in the MM and MI analyses. Improved estimates of treatment effect were observed with LOCF, MM and MI compared with CC; only MM provided improved estimates across all six outcomes considered. CONCLUSIONS: The FREE trial results are robust as the alternative methods used for substituting missing data produced similar results. The MM method showed the highest statistical precision suggesting it is the most appropriate method to use for analysing the FREE trial data. TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov (number NCT00211211).

Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial.

Vertebral fractures are often painful and lead to reduced quality of life and disability. We compared the efficacy and safety of balloon kyphoplasty to nonsurgical therapy over 24 months in patients with acute painful fractures. Adults with one to three vertebral fractures were randomized within 3 months from onset of pain to undergo kyphoplasty (n = 149) or nonsurgical therapy (n = 151). Quality of life, function, disability, and pain were assessed over 24 months. Kyphoplasty was associated with greater improvements in Short-Form 36 (SF-36) Physical Component Summary (PCS) scores when averaged across the 24-month follow-up period compared with nonsurgical therapy [overall treatment effect 3.24 points, 95% confidence interval (CI) 1.47-5.01, p = .0004]; the treatment difference remained statistically significant at 6 months (3.39 points, 95% CI 1.13-5.64, p = .003) but not at 12 months (1.70 points, 95% CI -0.59 to 3.98, p = .15) or 24 months (1.68 points, 95% CI -0.63 to 3.99, p = .15). Greater improvement in back pain was observed over 24 months for kyphoplasty (overall treatment effect -1.49 points, 95% CI -1.88 to -1.10, p < .0001); the difference between groups remained statistically significant at 24 months (-0.80 points, 95% CI -1.39 to -0.20, p = .009). There were two device-related serious adverse events in the second year that occurred at index vertebrae (a spondylitis and an anterior cement migration). There was no statistically significant difference between groups in the number of patients (47.5% for kyphoplasty, 44.1% for control) with new radiographic vertebral fractures; fewer fractures occurred (~18%) within the second year. Compared with nonsurgical management, kyphoplasty rapidly reduces pain and improves function, disability, and quality of life without increasing the risk of additional vertebral fractures. The differences from nonsurgical management are statistically significant when averaged across 24 months. Most outcomes are not statistically different at 24 months, but the reduction in back pain remains statistically significant at all time points.

Traumatic posterior lumbosacral spondyloptosis in a six-year-old: a case report and review of the literature.

STUDY DESIGN: Report of a traumatic posterior lumbosacral spondyloptosis in a 6-year-old. OBJECTIVES: To describe this type of fracture-dislocation in children. To evaluate a possible trauma mechanism. To evaluate specific characteristics of this type of lesion in children. SUMMARY OF BACKGROUND DATA: Fractures of the lumbar spine in children are rare. They are without exception caused by high-energy trauma. Fracture-dislocations mostly occur in the anterior direction. There are several reports of traumatic retrolisthesis in adults. To our knowledge, this is the first report of a retrolisthesis at the lumbosacral junction in a child. METHODS: While sitting, a 6-year-old boy was hit by a truck. He presented with a flaccid paraparesis below L3. Radiologic investigations showed a posterior spondyloptosis at L5-S1. He was treated by open reduction with a pediatric posterior spinal instrumentation and posterolateral grafting. RESULTS: After 1 year, the patient showed good radiologic fracture reduction and graft incorporation. There was no pain in the lumbar area. There was still a complete neurologic deficit beneath the L3 level, with loss of bladder and anal sphincter function. The patient was entered into a children's rehabilitation program 5 weeks after surgery and is continuously improving his overall functional level. CONCLUSION: Traumatic retrolisthesis of the lumbosacral spine is extremely rare, especially in children. We believe shear force while sitting is the key traumatic factor. We believe a simple posterior fusion with posterolateral grafting is sufficient to stabilize the spine in children. Extensive soft tissue damage causes an elevated risk of infection. Because of root avulsion, the level of paralysis can be several levels higher than the level of dislocation.

Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial.

BACKGROUND: Balloon kyphoplasty is a minimally invasive procedure for the treatment of painful vertebral fractures, which is intended to reduce pain and improve quality of life. We assessed the efficacy and safety of the procedure. METHODS: Adults with one to three acute vertebral fractures were eligible for enrolment in this randomised controlled trial at 21 sites in eight countries. We randomly assigned 300 patients by a computer-generated sequence to receive kyphoplasty treatment (n=149) or non-surgical care (n=151). The primary outcome was the difference in change from baseline to 1 month in the short-form (SF)-36 physical component summary (PCS) score (scale 0-100) between the kyphoplasty and control groups. Quality of life and other efficacy measurements and safety were assessed up to 12 months. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00211211. FINDINGS: 138 participants in the kyphoplasty group and 128 controls completed follow-up at 1 month. By use of repeated measures mixed effects modelling, all 300 randomised participants were included in the analysis. Mean SF-36 PCS score improved by 7.2 points (95% CI 5.7-8.8), from 26.0 at baseline to 33.4 at 1 month, in the kyphoplasty group, and by 2.0 points (0.4-3.6), from 25.5 to 27.4, in the non-surgical group (difference between groups 5.2 points, 2.9-7.4; p<0.0001). The frequency of adverse events did not differ between groups. There were two serious adverse events related to kyphoplasty (haematoma and urinary tract infection); other serious adverse events (such as myocardial infarction and pulmonary embolism) did not occur perioperatively and were not related to procedure. INTERPRETATION: Our findings suggest that balloon kyphoplasty is an effective and safe procedure for patients with acute vertebral fractures and will help to inform decisions regarding its use as an early treatment option.