Tibial Baseplate Migration Is Not Associated with Change in Patient-Reported Outcome Measures and Clinical Scores After TKA: A Secondary Analysis of 5 Radiostereometric Analysis Studies with 10-Year Follow-up.

BACKGROUND: Radiostereometric analysis (RSA) provides highly accurate data about the migration of a total knee arthroplasty (TKA) component. However, patient-reported outcome measures (PROMs) reflect the patients' perspective of their functional status, pain, and overall health after TKA. The aim of this study was to evaluate the association between tibial implant migration and change in postoperative PROMs and clinical scores, using data pooled from long-term follow-up RSA studies. METHODS: Individual implant migration data were collected from 5 randomized RSA studies, including a total of 300 patients with 6 distinct TKA implant designs (all Stryker). Tibial implant migration (maximum total point motion [MTPM]) was evaluated with RSA at 3 months, 1 year, and 2, 5, 7, and 10 years postoperatively. The Knee Society Score (KSS)-Knee and KSS-Function and Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales were collected in all studies at the same follow-up times. Linear mixed-effects models, with adjustment for TKA implant design and patient characteristics, were used to analyze the data. The 3-month follow-up visit was used as the baseline to assess the association between implant migration and PROMs across the 10-year follow-up. RESULTS: No association between tibial implant migration and change in KSS-Knee (p = 0.384), KSS-Function (p = 0.737), KOOS-Symptoms (p = 0.398), KOOS-Pain (p = 0.699), KOOS-Activities of Daily Living (p = 0.205), KOOS-Sport and Recreation (p = 0.702), or KOOS-Quality of Life (p = 0.368) was found across the entire follow-up. Similar results were found when using the 2-year follow-up as the baseline, after which both cemented and uncemented implants are expected to have stabilized. CONCLUSIONS: Tibial baseplate migration was not associated with postoperative worsening in PROMs or clinical scores in patients who underwent TKA. These findings suggest that implant migration, as measured with RSA, measures a different parameter (i.e., implant-bone fixation) than PROMs (i.e., patient perception) and clinical scores. Therefore, to assess the performance and safety of TKA implant designs, RSA and PROMs cannot be used interchangeably during the postoperative follow-up of patients and evaluation of the fixation of knee implants. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Multiple Joint Arthroplasty in Hip and Knee Osteoarthritis Patients: A National Longitudinal Cohort Study.

BACKGROUND: Many patients suffer from osteoarthritis (OA) in multiple joints, possibly resulting in multiple joint arthroplasties (MJAs). Primarily, we determined the cumulative incidence (Cin) of MJA in hip and knee joints up to 10 years. Secondly, we calculated the mean time between the first and subsequent joint arthroplasty, and evaluated the different MJA trajectories. Lastly, we compared patient characteristics and outcomes (functionality and pain) after surgery between MJA patients and single hip arthroplasty or knee arthroplasty (HA and KA) patients. METHODS: Primary index (first) HA or KA for OA were extracted from the Dutch Arthroplasty Register. The 1, 2, 5, and 10-year Cin (including competing risk death) of MJA, mean time intervals, and MJA-trajectories were calculated and stratified for primary index HA or KA. Sex, preoperative age, and body mass index were compared using ordinal logistic regression. Outcomes, measured preoperatively, 3, 6, and 12 months postoperatively (function: Hip Disability or Knee Injury and OA Outcome Score; Pain: Numerical Rating Scale), were compared using linear regression. RESULTS: A total of 140,406 HA-patients and 140,268 KA-patients were included. One, 2, 5, and 10-year Cin for a second arthroplasty were respectively 8.9% [95% confidence interval (CI): 8.7 to 9.0], 14.3% [95% CI: 14.1 to 14.5], 24.0% [95% CI: 23.7 to 24.2], and 32.7% [95% CI: 32.2 to 33.1] after index HA, and 9.5% [95% CI: 9.4 to 9.7], 16.0% [95% CI: 15.9 to 16.2], 26.4% [95% CI: 26.1 to 26.6], and 35.8% [95% CI: 35.4 to 36.3] after index KA. The 10-year Cin for > 2 arthroplasties were small in both the index HA and KA groups. Time-intervals from first to second, third, and fourth arthroplasty were 26 [95% CI: 26.1 to 26.7], 47 [95% CI: 46.4 to 48.4], and 58 [95% CI: 55.4 to 61.1] months after index HA, and 26 [95% CI: 25.9 to 26.3], 52 [95% CI: 50.8 to 52.7], and 61 [95% CI: 58.3 to 63.4] months after index KA. There were 83% of the second arthroplasties placed in the contralateral cognate joint (ie, knee or hip). Differences in postoperative functionality and pain between MJAs and single HAs and KAs were small. CONCLUSIONS: The 10-year Cin showed that about one-third of patients received a second arthroplasty after approximately 2 years, with the majority in the contralateral cognate joint. Few patients received > 2 arthroplasties within 10 years. Being a women, having a higher body mass index, and being younger increased the odds of MJA. Postoperative outcomes were slightly negatively affected by MJA.

Validating Orthopaedic Data Evaluation Panel (ODEP) Ratings Across 9 Orthopaedic Registries: Total Hip Implants with an ODEP Rating Perform Better Than Those without an ODEP Rating.

BACKGROUND: Orthopaedic Data Evaluation Panel (ODEP) ratings of total hip (TH) and total knee (TK) implants are informative for assessing implant performance. However, the validity of ODEP ratings across multiple registries is unknown. Therefore, we aimed to assess, across multiple registries, whether TH and TK implants with a higher ODEP rating (i.e., an A* rating) have lower cumulative revision risks (CRRs) than those with a lower ODEP rating (i.e., an A rating) and the extent to which A* and A-rated implants would be A*-rated on the basis of the pooled registries' CRR. METHODS: Implant-specific CRRs at 3, 5, and 10 years that were reported by registries were matched to ODEP ratings on the basis of the implant name. A meta-analysis with random-effects models was utilized for pooling the CRRs. ODEP benchmark criteria were utilized to classify these pooled CRRs. RESULTS: A total of 313 TH cups (54%), 356 TH stems (58%), 218 TH cup-stem combinations (34%), and 68 TK implants (13%) with unique brand names reported by registries were matched to an ODEP rating. Given the low percentage that matched, TK implants were not further analyzed. ODEP-matched TH implants had lower CRRs than TH implants without an ODEP rating at all follow-up time points, although the difference for TH stems was not significant at 5 years. No overall differences in CRRs were found between A* and A-rated TH implants, with the exception of TH cup-stem combinations, which demonstrated a significantly lower CRR for A*A*-rated cup-stem combinations at the 3-year time point. Thirty-nine percent of A*-rated cups and 42% of A*-rated stems would receive an A* rating on the basis of the pooled registries' CRR at 3 years; however, 24% of A-rated cups and 31% of A-rated stems would also receive an A* rating, with similar findings demonstrated at longer follow-up. CONCLUSIONS: At all follow-up time points, ODEP-matched TH implants had lower CRRs than TH implants without an ODEP rating. Given that the performance of TH implants varied across countries, registries should first validate ODEP ratings with use of country-specific revision data to better guide implant selection in their country. Data source transparency and the use of revision data from multiple registries would strengthen the ODEP benchmarks. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Influence of marker-selection method in radiostereometric analysis of total knee arthroplasty on tibial baseplate migration patterns: a secondary analysis of a randomized controlled trial with 5-year follow-up.

BACKGROUND AND PURPOSE:  Different marker-selection methods are applied to represent implant and tibial segments in radiostereometric analysis (RSA) studies of total knee arthroplasty (TKA). Either a consistent set of markers throughout subsequent RSA examinations ("consistent-marker method") is used or all available markers at each follow-up ("all-marker method"). The aim of this secondary analysis was to compare marker-selection methods on individual and group level TKA migration results. METHODS:  Data from a randomized RSA study with 72 patients was included. Tibial baseplate migration was evaluated at 3 months, 1, 2, and 5 years postoperatively with both marker-selection methods. Additionally, migration was calculated using 5 fictive points, either plotted based on the consistent set of markers or all available markers. RESULTS:  Migration could be calculated with both marker-selection methods for 248 examinations. The same prosthesis and bone markers (n = 136), different prosthesis markers (n = 71), different bone markers (n = 21), or different prosthesis and bone markers (n = 20) were used. The mean difference in maximum total point motion (MTPM) between all examinations was 0.02 mm, 95% confidence interval -0.26 to 0.31 mm. 5 implants were classified as continuously migrating with the consistent-marker method versus 6 implants (same 5 plus one additional implant) with the all-marker method. Using fictive points, fewer implants were classified as continuously migrating in both marker-selection methods. Differences between TKA groups in mean MTPM were comparable with both marker-selection methods, also when fictive points were used. CONCLUSION:  Estimated group differences in mean MTPM were similar between marker-selection methods, but individual migration results differed. The latter has implications when classifying implants for estimated risk of future loosening.

Changes in Health-Related Quality of Life following Surgery in Patients with High-Grade Extremity Soft-Tissue Sarcoma: A Prospective Longitudinal Study.

INTRODUCTION: Changes in health-related quality of life (HRQoL) during the diagnostic and treatment trajectory of high-grade extremity soft-tissue sarcoma (eSTS) has rarely been investigated for adults (18-65 y) and the elderly (aged ≥65 y), despite a potential variation in challenges from diverse levels of physical, social, or work-related activities. This study assesses HRQoL from time of diagnosis to one year thereafter among adults and the elderly with eSTS. METHODS: HRQoL of participants from the VALUE-PERSARC trial (n = 97) was assessed at diagnosis and 3, 6 and 12 months thereafter, utilizing the PROMIS Global Health (GH), PROMIS Physical Function (PF) and EQ-5D-5L. RESULTS: Over time, similar patterns were observed in all HRQoL measures, i.e., lower HRQoL scores than the Dutch population at baseline (PROMIS-PF:46.8, PROMIS GH-Mental:47.3, GH-Physical:46.2, EQ-5D-5L:0.76, EQ-VAS:72.6), a decrease at 3 months, followed by an upward trend to reach similar scores as the general population at 12 months (PROMIS-PF:49.9, PROMIS GH-Physical:50.1, EQ-5D-5L:0.84, EQ-VAS:81.5), except for the PROMIS GH-Mental (47.5), where scores remained lower than the general population mean (T = 50). Except for the PROMIS-PF, no age-related differences were observed. CONCLUSIONS: On average, eSTS patients recover well physically from surgery, yet the mental component demonstrates no progression, irrespective of age. These results underscore the importance of comprehensive care addressing both physical and mental health.

Reduction in use of MRI and arthroscopy among patients with degenerative knee disease in independent treatment centers versus general hospitals: a time series analysis.

The use of MRI and arthroscopy are considered low-value care in most patients with degenerative knee disease. To reduce these modalities, there have been multiple efforts to increase awareness. Reductions have been shown for general hospitals (GH), but it is unclear whether this may be partly explained by a shift of patients receiving these modalities in independent treatment centers (ITCs). The aims of this study were to assess (i) whether the trend in use of MRI and arthroscopy in patients with degenerative knee disease differs between ITCs and GH, and (ii) whether the Dutch efforts to raise awareness on these recommendations were associated with a change in the trend for both types of providers. All patients insured by a Dutch healthcare insurer aged ≥50 years with a degenerative knee disease who were treated in a GH or ITC between July 2014 and December 2019 were included. Linear regression was used with the quarterly percentage of patients receiving an MRI or knee arthroscopy weighted by center volume, as the primary outcome. Interrupted time-series analysis was used to evaluate the effect of the Dutch efforts to raise awareness. A total of 14 702 patients included were treated in 90 GHs (n = 13 303, 90.5%) and 29 ITCs (n = 1399, 9.5%). Across the study period, ITCs on an average had a 16% higher MRI use (P < .001) and 9% higher arthroscopy use (P = .003). MRI use did not change in both provider types, but arthroscopy use significantly decreased and became stronger in ITCs (P = .01). The Dutch efforts to increase awareness did not significantly influence either MRI or arthroscopy use in ITCs (P = .55 and P = .84) and GHs (P = .13 and P = .70). MRI and arthroscopy uses were higher in ITCs than GHs. MRI use did not change significantly among patients ≥ 50 years with degenerative knee disease in both provider types between 2014 and 2019. MRI- and arthroscopy use decreased with ITCs on average having higher rates for both modalities, but also showing a stronger decrease in arthroscopy use. The Dutch efforts to increase awareness did not accelerate the already declining trend in the Netherlands.

Biomarkers to discriminate between aseptic loosened and stable total hip or knee arthroplasties: a systematic review.

Background: Loosening is a major cause for failure of total hip and total knee arthroplasties (THAs/TKAs). Preemptive diagnostics of asymptomatic loosening could open strategies to prevent gross loosening. A multitude of biomarkers may discriminate between loosened and stable implants, but it is unknown which have the best performance. The present systematic review aimed to assess which biomarkers have shown the most promising results in discriminating between stable and aseptic loosened THAs and TKAs. Methods: PubMed, Embase, Web of Science, Cochrane Library, and Academic Search Premier were systematically searched up to January 2020 for studies including THA/TKA and biomarkers to assess loosening. Two reviewers independently screened records, extracted data, and assessed the risk of bias using the ICROMS tool to classify the quality of the studies. Results: Twenty-eight (three high-quality) studies were included, reporting on a median of 48 patients (interquartile range 28-69). Serum and urine markers were evaluated in 22 and 10 studies, respectively. Tumor necrosis factor α and osteocalcin were significantly higher in loosened compared with stable implants. Urinary N-terminal telopeptide had significantly elevated levels in loosened prostheses. Conclusion: Several serum and urine markers were promising in discriminating between loosened and stable implants. We recommend future studies to evaluate these biomarkers in a longitudinal fashion to assess whether progression of loosening is associated with a change in these biomarkers. In particular, high-quality studies assessing the usability of these biomarkers are needed.

Migration and clinical outcomes of a novel cementless hydroxyapatite-coated titanium acetabular shell: two-year follow-up of a randomized controlled trial using radiostereometric analysis.

Aims: The objective of this study was to compare the two-year migration and clinical outcomes of a new cementless hydroxyapatite (HA)-coated titanium acetabular shell with its previous version, which shared the same geometrical design but a different manufacturing process for applying the titanium surface. Methods: Overall, 87 patients undergoing total hip arthroplasty (THA) were randomized to either a Trident II HA or Trident HA shell, each cementless with clusterholes and HA-coating. All components were used in combination with a cemented Exeter V40 femoral stem. Implant migration was measured using radiostereometric analysis (RSA), with radiographs taken within two days of surgery (baseline), and at three, 12, and 24 months postoperatively. Proximal acetabular component migration was the primary outcome measure. Clinical scores and patient-reported outcome measures (PROMs) were collected at each follow-up. Results: Mean proximal migrations at three, 12, and 24 months were 0.08 mm (95% confidence interval (CI) 0.03 to 0.14), 0.11 mm (95% CI 0.06 to 0.16), and 0.14 mm (95% CI 0.09 to 0.20), respectively, in the Trident II HA group, versus 0.11 mm (95% CI 0.06 to 0.16), 0.12 mm (95% CI 0.07 to 0.17), and 0.14 mm (95% CI 0.09 to 0.19) in the Trident HA group (p = 0.875). No significant differences in translations or rotations between the two designs were found in any other direction. Clinical scores and PROMs were comparable between groups, except for an initially greater postoperative improvement in Hip disability and Osteoarthritis Outcome Symptoms score in the Trident HA group (p = 0.033). Conclusion: The Trident II clusterhole HA shell has comparable migration with its predecessor, the Trident hemispherical HA cluster shell, suggesting a similar risk of long-term aseptic loosening.

(Cost-)effectiveness of an individualised risk prediction tool (PERSARC) on patient's knowledge and decisional conflict among soft-tissue sarcomas patients: protocol for a parallel cluster randomised trial (the VALUE-PERSARC study).

INTRODUCTION: Current treatment decision-making in high-grade soft-tissue sarcoma (STS) care is not informed by individualised risks for different treatment options and patients' preferences. Risk prediction tools may provide patients and professionals insight in personalised risks and benefits for different treatment options and thereby potentially increase patients' knowledge and reduce decisional conflict. The VALUE-PERSARC study aims to assess the (cost-)effectiveness of a personalised risk assessment tool (PERSARC) to increase patients' knowledge about risks and benefits of treatment options and to reduce decisional conflict in comparison with usual care in high-grade extremity STS patients. METHODS: The VALUE-PERSARC study is a parallel cluster randomised control trial that aims to include at least 120 primarily diagnosed high-grade extremity STS patients in 6 Dutch hospitals. Eligible patients (≥18 years) are those without a treatment plan and treated with curative intent. Patients with sarcoma subtypes or treatment options not mentioned in PERSARC are unable to participate. Hospitals will be randomised between usual care (control) or care with the use of PERSARC (intervention). In the intervention condition, PERSARC will be used by STS professionals in multidisciplinary tumour boards to guide treatment advice and in patient consultations, where the oncological/orthopaedic surgeon informs the patient about his/her diagnosis and discusses benefits and harms of all relevant treatment options. The primary outcomes are patients' knowledge about risks and benefits of treatment options and decisional conflict (Decisional Conflict Scale) 1 week after the treatment decision has been made. Secondary outcomes will be evaluated using questionnaires, 1 week and 3, 6 and 12 months after the treatment decision. Data will be analysed following an intention-to-treat approach using a linear mixed model and taking into account clustering of patients within hospitals. ETHICS AND DISSEMINATION: The Medical Ethical Committee Leiden-Den Haag-Delft (METC-LDD) approved this protocol (NL76563.058.21). The results of this study will be reported in a peer-review journal. TRIAL REGISTRATION NUMBER: NL9160, NCT05741944.

Substantial Variation in Decision Making to Perform Subacromial Decompression Surgery for Subacromial Pain Syndrome Between Orthopaedic Shoulder Surgeons for Identical Clinical Scenarios: A Case-Vignette Study.

Purpose: To provide further insight into the variation in decision making to perform subacromial decompression (SAD) surgery in patients with subacromial pain syndrome (SAPS) and its influencing factors. Methods: Between November 2021 and February 2022, we invited 202 Dutch Shoulder and Elbow Society members to participate in a cross-sectional Web-based survey including 4 clinical scenarios of SAPS patients. Scenarios varied in patient characteristics, clinical presentation, and other contextual factors. For each scenario, respondents were asked (1) to indicate whether they would perform SAD surgery, (2) to indicate the probability of benefit of SAD surgery (i.e., pain reduction), (3) to indicate the probability of harm (i.e., complications), and (4) to rank the 5 most important factors influencing their treatment decision. Results: A total of 78 respondents (39%) participated. The percentage of respondents who would perform SAD surgery ranged from 4% to 25% among scenarios. The median probability of perceived benefit ranged between 70% and 79% across scenarios for respondents indicating to perform surgery compared with 15% to 29% for those indicating not to perform surgery. The difference in the median probability of perceived harm ranged from 3% to 9% for those indicating to perform surgery compared with 8% to 13% for those indicating not to perform surgery. Surgeons who would perform surgery mainly reported patient-related factors (e.g., complaint duration and response to physical therapy) as the most important factors to perform SAD surgery, whereas surgeons who would not perform surgery mainly reported guideline-related factors. Conclusions: Overall, Dutch orthopaedic shoulder surgeons are reluctant to perform SAD surgery in SAPS patients. There is substantial variation among orthopaedic surgeons regarding decisions to perform SAD surgery for SAPS even when evaluating identical scenarios, where particularly the perceived benefit of surgery differed between those who would perform surgery and those who would not. Surgeons who would not perform SAD surgery mainly referred to guideline-related factors as influential factors for their decision, whereas those who would perform SAD surgery considered patient-related factors more important. Clinical Relevance: There is substantial variation in decision making to perform SAD surgery for SAPS between individual orthopaedic surgeons for identical case scenarios.

Clinical outcomes of non-COVID-19 orthopaedic patients admitted during the COVID-19 pandemic: a multi-centre interrupted time series analysis across hospitals in six different countries.

OBJECTIVES: To assess across seven hospitals from six different countries the extent to which the COVID-19 pandemic affected the volumes of orthopaedic hospital admissions and patient outcomes for non-COVID-19 patients admitted for orthopaedic care. DESIGN: A multi-centre interrupted time series (ITS) analysis. SETTING: Seven hospitals from six countries who collaborated within the Global Health Data@Work collaborative. PARTICIPANTS: Non-COVID-19 patients admitted for orthopaedic care during the pre-pandemic (January/2018-February/2020) and COVID-19 pandemic (March/2020-June/2021) period. Admissions were categorised as: (1) acute admissions (lower limb fractures/neck of femur fractures/pathological fractures/joint dislocations/upper limb fractures); (2) subacute admissions (bone cancer); (3) elective admissions (osteoarthritis). OUTCOME MEASURES: Monthly observed versus expected ratios (O/E) were calculated for in-hospital mortality, long (upper-decile) length-of-stay and hospital readmissions, with expected rates calculated based on case-mix. An ITS design was used to estimate the change in level and/or trend of the monthly O/E ratio by comparing the COVID-19 pandemic with the pre-pandemic period. RESULTS: 69 221 (pre-pandemic) and 22 940 (COVID-19 pandemic) non-COVID-19 orthopaedic patient admissions were included. Admission volumes were reduced during the COVID-19 pandemic for all admission categories (range: 33%-45%), with more complex patients treated as shown by higher percentages of patients admitted with ≥1 comorbidity (53.8% versus 49.8%, p<0.001). The COVID-19 pandemic was not associated with significant changes in patient outcomes for most diagnostic groups. Only for patients diagnosed with pathological fractures (pre-pandemic n=1671 and pandemic n=749), the COVID-19 pandemic was significantly associated with an immediate mortality reduction (level change of -77.7%, 95% CI -127.9% to -25.7%) and for lower limb fracture patients (pre-pandemic n=9898 and pandemic n=3307) with a significantly reduced trend in readmissions (trend change of -6.3% per month, 95% CI -11.0% to -1.6%). CONCLUSIONS: Acute, subacute, as well as elective orthopaedic hospital admissions volumes were reduced in all global participating hospitals during the COVID-19 pandemic, while overall patient outcomes for most admitted non-COVID-19 patients remained the same despite the strain caused by the surge of COVID-19 patients.

Follow-Up after Curative Surgical Treatment of Soft-Tissue Sarcoma for Early Detection of Recurrence: Which Patients Have More or Fewer Visits than Advised in Guidelines?

INTRODUCTION: Follow-up (FU) in soft-tissue sarcoma (STS) patients is designed for early detection of disease recurrence. Current guidelines are not evidenced-based and not tailored to patient or tumor characteristics, so they remain debated, particularly given concerns about cost, radiation frequency, and over-testing. This study assesses the extent to which STS patients received guideline-concordant FU and to characterize which type of patients received more or fewer visits than advised. METHODS: All STS patients surgically treated at the Leiden University Medical Center between 2000-2020 were included. For each patient, along with individual characteristics, all radiological examinations from FU start up to 5 years were included and compared to guidelines. Recurrence was defined as local/regional recurrence or metastasis. RESULTS: A total of 394 patients was included, of whom 250 patients had a high-grade tumor (63.5%). Only 24% of patients received the advised three FU visits in the first year. More FU visits were observed in younger patients and those diagnosed with a high-grade tumor. Among patients with a recurrence, 10% received fewer visits than advised, while 28% of patients without a recurrence received more visits than advised. CONCLUSIONS: A minority of STS patients received guideline-concordant FU visits, suggesting that clinicians seem to incorporate recurrence risk in decisions on FU frequency.

Predictors for postoperative cranial nerve complications in carotid body tumor resection: a retrospective cohort study.

INTRODUCTION: Carotid body tumors (CBTs) are slow-growing benign tumors. Therefore, surgical resection is considered in case of tumor growth. The timing of surgery is of the utmost importance as the risk of iatrogenic surgical complications increases when resecting larger tumors, whereas on the other hand, resections for asymptomatic small CBT should be prevented. The primary aim of this study was to identify which tumor size or dimension is most accurate to predict nerve injury in patients undergoing resection of a CBT. MATERIAL AND METHODS: This retrospective cohort study included patients who underwent surgical resection of CBT at the university hospital in South-Holland. Baseline patient characteristics and tumor measurements were retrieved from the medical records. The authors assessed how the different methods of measuring the size of the tumor were interrelated using Pearson correlation. Logistic regression was used to assess which variables were independently associated with nerve injury, including age at surgery, Shamblin classification, and those dimensions that captured different aspects of tumor size (rather than measuring the same as shown by high correlations) as possible independent variables. RESULTS: In 125 patients, 143 CBTs were resected whereof in 35 cases cranial nerve injury occurred, (transient in 16 cases and permanent in 19 cases). The risks for nerve injury increased with larger tumor size and the Shamblin classification. Logistic regression analysis showed that the anterior-posterior (AP) diameter significantly increased the odds of a nerve injury, a doubling for every 1 cm increase in AP diameter [odds ratio (95% CI) 2.12 (1.29-3.48), P =0.003]. CONCLUSION: This study shows that measured tumor size in the AP plane is a strong predictor for postoperative nerve injury of a CBT resection. This predictor can be used in the daily clinic to give insight in operative risks. More research is needed in order to select the most appropriate time window for CBT resection.

Continued Stabilization of a Cementless 3D-Printed Total Knee Arthroplasty: Five-Year Results of a Randomized Controlled Trial Using Radiostereometric Analysis.

BACKGROUND: Three-dimensional (3D) printing of highly porous orthopaedic implants aims to promote better osseointegration, thus preventing aseptic loosening. However, short-term radiostereometric analysis (RSA) after total knee arthroplasty (TKA) has shown higher initial migration of cementless 3D-printed tibial components compared with their cemented counterparts. Therefore, critical evaluation of longer-term tibial component migration is needed. We investigated migration of a cementless 3D-printed and a cemented tibial component with otherwise similar TKA design during 5 years of follow-up, particularly the progression in migration beyond 2 years postoperatively. METHODS: Seventy-two patients were randomized to a cementless 3D-printed Triathlon Tritanium (Stryker) cruciate-retaining (CR) TKA or a cemented Triathlon CR (Stryker) TKA implant. Implant migration was evaluated with RSA at baseline and postoperatively at 3 months and at 1, 2, and 5 years. The maximum total point motion (MTPM) of the tibial component was compared between the groups at 5 years, and progression in migration was assessed between 2 and 5 years. Individual implants were classified as continuously migrating if the MTPM was ≥0.1 mm/year beyond 2 years postoperatively. Clinical scores were evaluated, and a linear mixed-effects model was used to analyze repeated measurements. RESULTS: At 5 years, the mean MTPM was 0.66 mm (95% confidence interval [CI], 0.56 to 0.78 mm) for the cementless group and 0.53 mm (95% CI, 0.43 to 0.64 mm) for the cemented group (p = 0.09). Between 2 and 5 years, there was no progression in mean MTPM for the cementless group (0.02 mm; 95% CI, -0.06 to 0.10 mm) versus 0.07 mm (95% CI, 0.00 to 0.14) for the cemented group. One implant was continuously migrating in the cementless group, and 4 were continuously migrating in the cemented group. The clinical scores were comparable between the groups across the entire time of follow-up. CONCLUSIONS: No significant difference in mean migration was found at 5 years between the cementless and cemented TKA implants. Progression of tibial component migration was present beyond 2 years for the cemented implant, whereas the cementless implant remained stable after initial early migration. LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.

BACKGROUND: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes. METHODS: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes. RESULTS: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations. CONCLUSION: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.

Health-Related Quality of Life of Bone and Soft-Tissue Tumor Patients around the Time of Diagnosis.

BACKGROUND: Bone and soft-tissue tumor patients experience long-lasting physical and psychological challenges. It is unknown to what extent Health-Related Quality of Life (HRQoL) is already affected during the diagnostic process. This study assesses the HRQoL of bone and soft-tissue tumor patients around time of diagnosis and explores which patient or tumor characteristics are associated with a reduced HRQoL. METHODS: All patients with a suspected benign/malignant bone tumor (BT), benign soft-tissue tumor (STT), or malignant soft-tissue sarcoma (STS) visiting the Leiden University Medical Center between 2016 and 2020 were invited to complete the Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item profile questionnaire. Mean scores of all included patients and per diagnosis group were compared to mean scores of the general population using one-sample t-tests. RESULTS: Overall, patients (n = 637) reported statistically significantly worse HRQoL-scores on anxiety (51.3 ± 9.6), pain (55.3 ± 10.1), physical functioning (46.0 ± 9.7), and social functioning (48.1 ± 10.8) with the difference in pain and physical functioning being clinically relevant (based on a 3-point difference on t-metric). HRQoL-scores differed between diagnosis subgroups, i.e., patients with malignant tumors had higher anxiety levels and experienced more pain, where patients with bone tumors had worse physical functioning. CONCLUSION: The HRQoL of patients with suspected bone and soft-tissue tumors is already affected during the diagnostic process.

Ageing and joint position sense of the asymptomatic shoulder: An observational study.

PURPOSE: This study aimed to quantify the extent to which age was associated with joint position sense (JPS) of the asymptomatic shoulder as measured by joint position reproduction (JPR) tasks and assess the reproducibility of these tasks. METHODS: 120 Asymptomatic participants aged 18-70 years each performed 10 JPR-tasks. Both contralateral and ipsilateral JPR-tasks were evaluated on accuracy of JPR under active- and passive conditions at two levels within the shoulder forward flexion trajectory. Each task was performed three times. In a subgroup of 40 participants, the reproducibility of JPR-tasks was assessed one week after initial measurement. Reproducibility of JPR-tasks was evaluated by both reliability (intra-class correlation coefficients (ICC's)) and agreement (standard error of measurement (SEM)) measures. RESULTS: Age was not associated with increased JPR-errors for any of the contralateral or ipsilateral JPR-tasks. ICC's ranged between 0.63 and 0.80 for contralateral JPR-tasks, and from 0.32 to 0.48 for ipsilateral tasks, except for one ipsilateral task where the reliability was similar to contralateral tasks (0.79). The SEM was comparable and small for all JPR-tasks, ranging between 1.1 and 2.1. CONCLUSION: No age-related decline in JPS of the asymptomatic shoulder was found, and good agreement between test and re-test measurements for all JPR-tasks as indicated by the small SEM.

The relationship between publication of high-quality evidence and changes in the volume and trend of subacromial decompression surgery for patients with subacromial pain syndrome in hospitals across Australia, Europe and the United States: a controlled interrupted time series analysis.

AIMS: To evaluate the extent to which publication of high-quality randomised controlled trials(RCTs) in 2018 was associated with a change in volume or trend of subacromial decompression(SAD) surgery in patients with subacromial pain syndrome(SAPS) treated in hospitals across various countries. METHODS: Routinely collected administrative data of the Global Health Data@work collaborative were used to identify SAPS patients who underwent SAD surgery in six hospitals from five countries (Australia, Belgium, Netherlands, United Kingdom, United States) between 01/2016 and 02/2020. Following a controlled interrupted time series design, segmented Poisson regression was used to compare trends in monthly SAD surgeries before(01/2016-01/2018) and after(02/2018-02/2020) publication of the RCTs. The control group consisted of musculoskeletal patients undergoing other procedures. RESULTS: A total of 3.046 SAD surgeries were performed among SAPS patients treated in five hospitals; one hospital did not perform any SAD surgeries. Overall, publication of trial results was associated with a significant reduction in the trend to use SAD surgery of 2% per month (Incidence rate ratio (IRR) 0.984[0.971-0.998]; P = 0.021), but with large variation between hospitals. No changes in the control group were observed. However, publication of trial results was also associated with a 2% monthly increased trend (IRR 1.019[1.004-1.034]; P = 0.014) towards other procedures performed in SAPS patients. CONCLUSION: Publication of RCT results was associated with a significantly decreased trend in SAD surgery for SAPS patients, although large variation between participating hospitals existed and a possible shift in coding practices cannot be ruled out. This highlights the complexities of implementing recommendations to change routine clinical practice even if based on high-quality evidence.