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1.
J Orthop ; 55: 134-148, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38706587

ABSTRACT

Introduction: When indicated, Birmingham Hip Resurfacing (BHR) presents a viable alternative to total hip arthroplasty (THA), but there remain questions about the long-term outcomes of BHR. Therefore, we asked: 1) what are the long-term patient-reported outcomes and 2) survivorship rates following BHR; 3) what are the causes for revision surgery after BHR? and 4) how have these outcomes compared to THA at long-term follow-up. Methods: A query of PubMed, MEDLINE, Scopus, and Cochrane in September 2023 was performed. Articles were included if they reported BHR survivorship rates at ≥10 years. Survivorship was defined as an all-cause revision of any BHR component. This review encompasses 26 articles, totaling 13,103 hips. Mean follow-up ranged from 6.0 to 20.9 years, but each study had at least a subgroup analysis for ≥10-year follow-up. Results: Five studies compared preoperative and postoperative PROs for BHR, with four reporting improvement in at least one PRO after 10-year follow-up. Overall, survivorship rates ranged from 83% to 100% across diverse long-term timeframes, with 25 of 26 studies reporting 10-year survivorship rates greater than 87%. The primary reasons for revisions were implant loosening (22%), adverse reactions to metal debris (21.2%), and fractures of any kind (17.2%). In the six studies that compared BHR to THA, long-term survivorship was similar while BHR exhibited slightly superior activity levels. Conclusion: The findings from this study suggested favorable long-term survivorship and postoperative outcomes of BHR. In studies comparing long-term BHR and THA, survivorship was comparable, with BHR potentially providing enhanced postoperative activity levels.

2.
J Robot Surg ; 18(1): 160, 2024 Apr 05.
Article in English | MEDLINE | ID: mdl-38578350

ABSTRACT

Robotic assisted (RA) total hip arthroplasty (THA) offers improved acetabular component placement and radiographic outcomes, but inconsistent assessment methods of its learning curves render the evaluation of adopting novel platforms challenging. Therefore, we conducted a systematic review to assess the learning curve associated with RA-THA, both tracking a surgeon's performance across initial cases and comparing their performance to manual THA (M-THA). PubMed, MEDLINE, EBSCOhost, and Google Scholar were searched on June 16, 2023, to identify studies published between January 1, 2000 and June 16, 2023 (PROSPERO registration: CRD42023437339). The query yielded 655 unique articles, which were screened for eligibility. The final analysis included 11 articles, evaluating 1351 THA procedures. Risk of bias was assessed via the Methodological Index for Nonrandomized Studies (MINORS) tool. The mean MINORS score was 21.3 ± 0.9. RA-THA provided immediate improvements in acetabular component placement accuracy and radiographic outcomes compared to M-THA, with little to no experience required to achieve peak proficiency. A modest learning curve (12-17 cases) was associated with operative time, which was elevated compared to M-THA (+ 9-13 min). RA-THA offers immediate advantages to M-THA for component placement accuracy and radiographic outcomes. Surgeons should expect to experience increased operative times, which become less pronounced or equivalent to M-THA after a modest caseload.


Subject(s)
Arthroplasty, Replacement, Hip , Robotic Surgical Procedures , Surgery, Computer-Assisted , Humans , Arthroplasty, Replacement, Hip/methods , Learning Curve , Robotic Surgical Procedures/methods , Acetabulum/diagnostic imaging , Acetabulum/surgery , Surgery, Computer-Assisted/methods
3.
J Orthop ; 53: 140-146, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38601894

ABSTRACT

Introduction: Although gluteal tears have been observed in a substantial percentage of total hip arthroplasty (THA) patients and hip osteoarthritis (OA) has been shown to alter the function of the gluteal muscles, the association between gluteal tears and hip OA has not been characterized. Therefore, we evaluated (1) the overlap between hip OA and gluteal tears, (2) the relative risks of gluteal tears in patients who have hip OA, and (3) gluteal tear-free survival after diagnosis or treatment for hip osteoarthritis. Methods: This retrospective study sourced data from TriNetX, a research network that aggregates data from over 92 million patients. Relative risks for gluteal tears were calculated for known risk factors for gluteal tears, age ≥45 years, female sex, and obesity, as well as for hip OA, hip injections, and THA. A subgroup analysis was performed utilizing a Cox proportional hazard model for patients who were diagnosed with hip OA, received a hip injection, or underwent THA in 2015 to assess gluteal tear-free survival over a 9-year timeframe. Results: There was a large degree of overlap between patients with hip OA and gluteal tears, as 17.9% of patients with hip OA and 27.5% of patients with a gluteal tear also had the other pathology. Hip OA was associated with a markedly increased risk of a gluteal tear compared to healthy controls (Relative risk: 26.75, 95% CI: 26.64-26.86). Upon controlling for the established risk factors of gluteal tears, patients with hip OA had a markedly more likely to subsequently be diagnosed with an abductor tear (Hazard ratio: 12.46, 95% CI: 11.75-13.22). Conclusion: Overall, these findings suggest a strong association between hip OA and the development of gluteal tears, in which further investigation is merited to determine the biomechanical pathophysiology underlying this potential relationship to inform prevention and treatment strategies.

4.
J Orthop ; 53: 125-132, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38515529

ABSTRACT

Introduction: Robotic-assisted (RA) and computer-navigated (CN) total hip arthroplasty (THA) have been demonstrated to improve component placement accuracy compared to manual THA (mTHA) for primary osteoarthritis. As hip dysplasia presents several additional challenges in component placement accuracy and leg length discrepancy (LLD) correction during THA, a systematic review was conducted to evaluate whether utilizing these platforms may be associated with superior outcomes over mTHA in patients who have hip dysplasia. Methods: PubMed, Medline, EBSCOhost, and Google Scholar were searched on September 13, 2023 to identify comparative studies published after January 1, 2000 that evaluated outcomes of RA-THA or CN-THA in patients who have hip dysplasia. The query yielded 197 unique articles, which were screened for alignment with the study aims. After screening, 10 studies fulfilled all inclusion criteria, comprising 946 patients. Risk of bias was evaluated via the Methodological Index for Nonrandomized Studies tool, and the mean score was 21.2 ± 1.5. Results: Both RA-THA and CN-THA were not associated with improved acetabular anteversion and inclination when evaluating Crowe I-IV types altogether compared to mTHA, but studies reported improved accuracy for each Crowe I and II cases when assessed individually. While studies reporting acetabular cup placement within the Lewinnek and Callanan safe zones consistently found higher odds of accurate positioning for RA-THA versus mTHA, accuracy in achieving targeted center of rotation was mixed. Also, studies reported no difference in LLD restoration for RA-THA and CN-THA compared to mTHA. While operative time may be increased when utilizing these platforms, they may also expedite specific sequences, offsetting most of the increase in operative time. Conclusion: This review highlights the advantages of RA-THA and CN-THA for patients who have DDH, particularly when treating Crowe I and II types as superior radiographic outcomes were achieved with these intraoperative technologies. However, there remains a need for studies to investigate whether this results in patient-reported outcome measures.

5.
Arch Orthop Trauma Surg ; 144(4): 1851-1858, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38430232

ABSTRACT

BACKGROUND: As the population ages, revision total hip arthroplasty (rTHA) is becoming more common. However, there is a paucity of literature regarding perioperative outcomes following inpatient versus outpatient rTHA. Our study aims to compare perioperative complications and readmission rates associated with rTHA in a large national cohort. METHODS: A retrospective, propensity-matched cohort study was conducted using the National Surgical Quality Improvement Program database from 2006 to 2020. Patients undergoing rTHA in the inpatient setting were propensity matched to patients receiving rTHA in the outpatient setting. Following 1:1 matching, multivariate analyses were performed to compare perioperative complications and readmission. RESULTS: A total of 207,102 patients were identified, including 181,164 outpatient primary THA, 25,466 inpatient rTHA, and 492 outpatient rTHA patients. Following propensity matching, outpatient primary THA versus outpatient rTHA had 210 patients and inpatient rTHA versus outpatient rTHA had 214 patients. Patients in the outpatient rTHA had a significantly higher operative time (132.4 ± 73.2 versus 90.9 ± 32.7, p < 0.001) and length of stay (1.6 ± 1.6 vs. 0.9 ± 1.0, p < 0.001) compared to outpatient primary THA. When comparing inpatient versus outpatient rTHA, the outpatient cohort had lower operative time (131.1 ± 70.9 vs. 145.4 ± 71.5, p = 0.038), total length of stay (1.7 ± 1.8 vs. 3.6 ± 4.1, p < 0.001), and bleeding complications (6% vs. 18%, p < 0.001). CONCLUSION: There were no difference in the odds of complications between outpatient primary and revision THA. Additionally, rTHA performed in an outpatient setting did not show any increase in immediate compared to inpatient settings. These findings suggest that rTHA can be safely performed on certain patients.


Subject(s)
Arthroplasty, Replacement, Hip , Humans , Arthroplasty, Replacement, Hip/adverse effects , Cohort Studies , Retrospective Studies , Inpatients , Outpatients , Reoperation/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/etiology
6.
J Surg Res ; 296: 711-719, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38367522

ABSTRACT

INTRODUCTION: To evaluate the readability of surgical clinical trial consent forms and compare readability across surgical specialties. METHODS: We conducted a cross-sectional analysis of surgical clinical trial consent forms available on ClinicalTrials.gov to quantitatively evaluate readability, word count, and length variations among different specialties. The analysis was performed between November 2022 and January 2023. A total of 386 surgical clinical trial consent forms across 14 surgical specialties were included. RESULTS: The main outcomes were language complexity (measured using Flesch-Kincaid Grade Level), number of words (measured as word count), time to read (measured at reading speeds of 240 per min), and readability (measured by Flesch Reading Ease Score, Gunning Frog Index, Simple Measures of Gobbledygook Index, FORCAST, and Automated Readability Index). The surgical consent forms were a mean (standard deviation) of 2626 (1668) words long, with a mean of 12:53 min to read at 240 words per min. None of the surgical specialties had an average readability level of sixth grade or lower across all six indices, and only 16 out of 386 (4%) clinical trials met the recommended reading level. Furthermore, there was no significant difference in reading grade level between surgical specialties based on the Flesch-Kincaid Grade Level and Flesch Reading Ease indices. CONCLUSIONS: Our findings suggest that current surgical clinical trial consent documents are too long and complex, exceeding the recommended sixth-grade reading level. Ensuring readable clinical trial consent forms is not only ethically responsible but also crucial for protecting patients' rights and well-being by facilitating informed decision-making.


Subject(s)
Consent Forms , Specialties, Surgical , Humans , Comprehension , Cross-Sectional Studies , Informed Consent , Internet
7.
Med Eng Phys ; 124: 104105, 2024 02.
Article in English | MEDLINE | ID: mdl-38418018

ABSTRACT

Accurate pre-operative templating of prosthesis components is an essential factor in successful total hip arthroplasty (THA), including robotically-assisted THA (RA-THA) techniques. We sought to validate the accuracy of a novel, robotic-optimized THA planning software compared to a predicate THA planner for component sizing. We analyzed a series of 199 patients who received manual THA (mTHA) and fluoroscopy-based RA-THA at a single institution. All cases were templated using a predicate pre-operative templating software. For RA-THA cases, the novel robotic-optimized pre-operative planner software was also used for templating. The differences between templated and implanted acetabular cup, femoral head, and stem component sizes were compared based on matching within 1, 2, and ≥3 sizes. Differences in templated and implanted femoral stem implant geometry were also compared. The robot-optimized pre-operative RA-THA plans demonstrated equivalent accuracy to that of predicate pre-operative plans for both RA-THA and mTHA cases. Templated acetabular cups (90.4 vs. 86.8 vs. 82.8; p = 0.421), femoral stems (76.0 vs. 65.1 vs. 67.7; p = 0.096), and femoral heads (91.3 vs. 96.2 vs. 88.2; p = 0.302) were within +/-1 size of implanted components. No significant differences were detected in the proportion of matching templated and implanted stem geometry across the study cohorts.


Subject(s)
Arthroplasty, Replacement, Hip , Hip Prosthesis , Robotic Surgical Procedures , Robotics , Humans , Arthroplasty, Replacement, Hip/methods , Hip Joint/surgery , Reproducibility of Results , Preoperative Care/methods , Acetabulum/diagnostic imaging , Acetabulum/surgery , Software , Retrospective Studies
8.
J Am Acad Orthop Surg ; 32(7): e313-e320, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38236910

ABSTRACT

INTRODUCTION: Posttraumatic osteoarthritis of the knee (PTOAK) is a known sequela of bony and soft-tissue articular knee injuries, although its historically reported prevalence is highly variable with no recent population-based studies. METHODS: The TriNetX/US Collaborative Network database was queried to identify adult patients diagnosed with a history of knee trauma using ICD-10-CM coding. Primary outcomes measured were yearly incidence proportion (IP), incidence rate (IR), and prevalence of knee osteoarthritis in the United States from 2000 to 2022. Chi square analyses were conducted to compare outcomes across categorical data. Regression modeling was performed to project PTOAK epidemiology to 2030. Statistical significance was held at P < 0.05 for all analyses. RESULTS: Nine hundred forty-eight thousand eight hundred fifty-three patients meeting criteria were identified. As of 2022, the IP of PTOAK was 5.93%, IR was 2.26 × 10 -4 cases/person-day, and prevalence was 21.1%. By strata in 2022, posttraumatic knee OA is most prevalent among the 54 to 59-year-old age group (50.9%), 60 to 64-year-old age group (50.3%), 50 to 54-year-old age group (49.7%), female patients (24.2%), and White patients (23.1%). Regression analyses revealed that the IP, IR, and prevalence of PTOAK have increased exponentially from 2000 to 2022. By 2030, the model predicts that the IP will further increase to 10.7% (95% PI = 9.79% to 11.7%), IR will be 3.79 × 10 -4 cases/person-day (95% PI = 3.28 × 10 -4 to 4.29 × 10 -4 ), and prevalence of PTOAK in the United States will be 40.6% (95% PI = 39.1% to 42.0%). DISCUSSION: These findings echo earlier, smaller scale studies but reveal an alarming rise in PTOAK prevalence, potentially doubling by 2030. The financial burden of knee OA treatment in the United States is already substantial, costing between $5.7 and $15 billion USD annually. This projected increase in prevalence could further increase healthcare expenditures by $1 to 3 billion by 2030. These results emphasize the need for additional research into factors contributing to PTOAK, evidence-based preventive public health interventions, and the development of multidisciplinary system-based care delivery optimization pathways.


Subject(s)
Knee Injuries , Osteoarthritis, Knee , Adult , Humans , Female , United States/epidemiology , Middle Aged , Osteoarthritis, Knee/epidemiology , Osteoarthritis, Knee/etiology , Regression Analysis , Forecasting , Delivery of Health Care , Knee Injuries/complications , Knee Injuries/epidemiology , Prevalence
9.
Arch Orthop Trauma Surg ; 144(1): 501-508, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37740783

ABSTRACT

BACKGROUND: While robotic-assisted total hip arthroplasty (RA-THA) has been associated with improved accuracy of component placement, the perioperative and early postoperative outcomes of fluoroscopy-based RA-THA systems have yet to be elucidated. METHODS: This retrospective cohort analysis included a consecutive series of patients who received manual, fluoroscopy-assisted THA (mTHA) and fluoroscopy-based RA-THA at a single institution. We compared rates of complications within 90 days of surgery, length of hospital stay (LOS), and visual analog scale (VAS) pain scores. RESULTS: No differences existed between groups with respect to demographic data or perioperative recovery protocols. The RA-THA cohort had a significantly greater proportion of outpatient surgeries compared to the mTHA cohort (37.4% vs. 3.8%; p < 0.001) and significantly lower LOS (26.0 vs. 39.5 h; p < 0.001). The RA-THA cohort had a smaller 90-day postoperative complication rate compared to the mTHA cohort (0.9% vs. 6.7%; p = 0.029). The RA-THA cohort had significantly lower patient-reported VAS pain scores at 2-week follow-up visits (2.5 vs. 3.3; p = 0.048), but no difference was seen after 6-week follow visits (2.5 vs. 2.8; p = 0.468). CONCLUSION: Fluoroscopy-based RA-THA demonstrates low rates of postoperative complications, improved postoperative pain profiles, and shortened LOS when compared to manual, fluoroscopy-assisted THA.


Subject(s)
Arthroplasty, Replacement, Hip , Robotic Surgical Procedures , Humans , Arthroplasty, Replacement, Hip/methods , Retrospective Studies , Robotic Surgical Procedures/methods , Treatment Outcome , Fluoroscopy , Postoperative Complications , Pain, Postoperative
10.
J Arthroplasty ; 2023 Nov 30.
Article in English | MEDLINE | ID: mdl-38040064

ABSTRACT

BACKGROUND: Patients undergoing total joint arthroplasty (TJA) who report penicillin allergy (PA) are frequently administered second-line antibiotics, although recent evidence suggests that this may be unnecessary and could increase infection risk. Many institutions have aimed to improve antibiotic deployment via allergy testing and screening; however, there is little standardization to this process. This review aimed to evaluate (1) antibiotic selection in patients who report PA and assess the impact of screening and testing interventions, (2) rates of allergic reactions in patients who report PA, and (3) the association between reported PA and screening or testing programs and odds of surgical site infection or periprosthetic joint infection. METHODS: PubMed, EBSCOhost, and Google Scholar electronic databases were searched on February 4, 2023 to identify all studies published since January 1, 2000 that evaluated the impact of PA on patients undergoing TJA (PROSPERO study protocol registration: CRD42023394031). Articles were included if full-text manuscripts in English were available, and the study analyzed the impact of PA and related interventions on TJA patients. There were 11 studies evaluating 1,276,663 patients included. Interventions were compared via presentation of key findings regarding rates of clinically relevant or high-risk PA reported upon screenings or testings, cephalosporin utilizations, allergic reactions, and postoperative infections (surgical site infection and periprosthetic joint infection). RESULTS: All 6 studies found that PA screening and testing markedly increase the use of first-line antibiotics. Testing showed low rates of true allergy (0.7 to 3%) and allergic reaction frequency for patients who have reported PA receiving cephalosporins was between 0% and 2%. Although there were mixed findings across studies, there was a trend toward second-line antibiotic prophylaxis being associated with a slightly higher rate of infection in PA patients. CONCLUSIONS: Using PA screening and testing can promote antibiotic stewardship by safely increasing the use of first-line antibiotics in patients who have a reported PA. LEVEL OF EVIDENCE: Level III, Therapeutic Study.

11.
Arthroplasty ; 5(1): 54, 2023 Nov 03.
Article in English | MEDLINE | ID: mdl-37919812

ABSTRACT

INTRODUCTION: In recent years, there has been a significant increase in the development of artificial intelligence (AI) algorithms aimed at reviewing radiographs after total joint arthroplasty (TJA). This disruptive technology is particularly promising in the context of preoperative planning for revision TJA. Yet, the efficacy of AI algorithms regarding TJA implant analysis has not been examined comprehensively. METHODS: PubMed, EBSCO, and Google Scholar electronic databases were utilized to identify all studies evaluating AI algorithms related to TJA implant analysis between 1 January 2000, and 27 February 2023 (PROSPERO study protocol registration: CRD42023403497). The mean methodological index for non-randomized studies score was 20.4 ± 0.6. We reported the accuracy, sensitivity, specificity, positive predictive value, and area under the curve (AUC) for the performance of each outcome measure. RESULTS: Our initial search yielded 374 articles, and a total of 20 studies with three main use cases were included. Sixteen studies analyzed implant identification, two addressed implant failure, and two addressed implant measurements. Each use case had a median AUC and accuracy above 0.90 and 90%, respectively, indicative of a well-performing AI algorithm. Most studies failed to include explainability methods and conduct external validity testing. CONCLUSION: These findings highlight the promising role of AI in recognizing implants in TJA. Preliminary studies have shown strong performance in implant identification, implant failure, and accurately measuring implant dimensions. Future research should follow a standardized guideline to develop and train models and place a strong emphasis on transparency and clarity in reporting results. LEVEL OF EVIDENCE: Level III.

12.
Arthroplasty ; 5(1): 56, 2023 Nov 04.
Article in English | MEDLINE | ID: mdl-37924164

ABSTRACT

BACKGROUND: Robot-assisted total hip arthroplasty (RA-THA) improves accuracy in achieving the planned acetabular cup positioning compared to conventional manual THA (mTHA), but optimal dosage for peri-RA-THA and mTHA pain relief remains unclear. This study aimed to compare pain control with opioids between patients undergoing direct anterior approach THA with the use of a novel, fluoroscopic-assisted RA-THA system compared to opioid consumption associated with fluoroscopic-assisted, manual technique. METHODS: Retrospective cohort analysis was performed on a consecutive series of patients who received mTHA and fluoroscopy-based RA-THA. The average amount of postoperative narcotics in morphine milligram equivalents (MME) given to each cohort was compared, including during the in-hospital and post-discharge periods. Analyses were performed on the overall cohort, as well as stratified by opioid-naïve and opioid-tolerant patients. RESULTS: The RA-THA cohort had significantly lower total postoperative narcotic use compared to the mTHA cohort (103.7 vs. 127.8 MME; P < 0.05). This difference was similarly seen amongst opioid-tolerant patients (123.6 vs. 181.3 MME; P < 0.05). The RA-THA cohort had lower total in-hospital narcotics use compared to the mTHA cohort (42.3 vs. 66.4 MME; P < 0.05), consistent across opioid-naïve and opioid-tolerant patients. No differences were seen in post-discharge opioid use between groups. CONCLUSIONS: Fluoroscopy-based RA-THA is associated with lower postoperative opioid use, including during the immediate perioperative period, when compared to manual techniques. This may have importance in rapid recovery protocols and mitigating episode burden of care.

13.
Int J Med Robot ; : e2582, 2023 Sep 30.
Article in English | MEDLINE | ID: mdl-37776329

ABSTRACT

BACKGROUND: The purpose of this study was to assess the cost-effectiveness of a novel, fluoroscopy-based robotic-assisted total hip arthroplasty (RA-THA) system compared to a manual unassisted technique (mTHA) up to 5 years post-operatively. METHODS: A Markov model was constructed to compare the cost-effectiveness of RA-THA and mTHA. Cost-effectiveness was defined as an Incremental Cost-Effectiveness Ratio (ICER) <$50 000 or $100 000 per Quality Adjusted Life Year (QALY). RESULTS: RA-THA patients experienced lower costs compared to mTHA patients at 1 year ($20 865.12 ± 9897.52 vs. $21 660.86 ± 9909.15; p < 0.001) and 5 years ($23 124.57 ± 10 045.48 vs. $25 756.42 ± 10 091.84; p < 0.001) post-operatively. RA-THA patients also accrued more QALYs (1-year: 0.901 ± 0.117 vs. 0.888 ± 0.114; p < 0.001; 5-years: 4.455 ± 0.563 vs. 4.384 ± 0.537 p < 0.001). Overall, RA-THA was cost-effective (1-year ICER: $-61 210.77; 5-year ICER: $-37 068.31). CONCLUSIONS: The novel, fluoroscopy-based RA-THA system demonstrated cost-effectiveness when compared to manual unassisted THA.

14.
Article in English | MEDLINE | ID: mdl-37493365

ABSTRACT

BACKGROUND: Serving as a principal investigator for a clinical trial can bring national visibility and recognition to physicians, and it can have a substantial impact on their promotion and tenure. In the field of orthopaedics, there is a well-known gender gap in terms of representation and leadership. Examining the representation of women in clinical trial leadership may help to inform and enable the design of targeted interventions and policies to foster a more inclusive and diverse environment in clinical trial leadership. QUESTIONS/PURPOSES: (1) What is the proportion of women principal investigators in orthopaedic clinical trials, and has this changed over time? (2) Are there trial characteristics (trial phase, status, funding source, and intervention) associated with women principal investigators? (3) What is the geographic distribution globally and regionally within the United States of clinical trials led by women principal investigators? METHODS: A cross-sectional survey of clinical trials using the ClinialTrials.gov registry and results database provided by the NIH was performed on August 22, 2022. Trial characteristics included principal investigator names and gender, trial phase, type, funding source, intervention, and location (defined by continent and US Census region). Our primary outcome was the overall proportion of women orthopaedic principal investigators over time. We assessed this by comparing the proportion of women principal investigators from 2007 to 2022. Our secondary outcomes were trial characteristics (trial phase, status, funding source, and intervention) and geographic distribution (globally and within the United States) associated with women principal investigators. Baseline characteristics of the clinical trials were calculated using frequencies and percentages for categorical variables. Fisher exact tests were conducted to evaluate differences in gender proportions based on the included clinical trial characteristics. Univariate linear regression was applied to analyze trends in the annual proportion of women principal investigators over time. RESULTS: The overall proportion of women principal investigators was 18% (592 of 3246), and this proportion increased over the study period. Specifically, the proportion of women leading clinical trials was 13% (16 of 121) in 2007 and 22% (53 of 242) in 2022 (r2 = 0.68; p < 0.001). This trend was also observed when evaluating only US women principal investigators (r2 = 0.47; p = 0.003) and non-US women principal investigators over the study period (r2 = 0.298; p = 0.03). There was no difference in the distribution of trial phases between men and women principal investigators. Most men and women were involved in "not applicable" or Phase IV trials. Similarly, there was no difference in trial status or funding source. However, women principal investigators had a higher proportion of studies involving behavioral interventions (11% [67 of 592]) compared with men principal investigators (3% [74 of 2654]; p = 0.03). The proportion of women principal investigators over the study period by world region revealed a higher proportion of women principal investigators in Asia (23% [88 of 391]), followed by South America (24% [12 of 49]), North America (18% [306 of 1746]), and Europe (16% [136 of 833]). Among all US trials over the study period, the proportion of women principal investigators across the US Census region was Northeast (19% [62 of 329]), South (18% [90 of 488]), West (20% [97 of 492]), and Midwest (13% [22 of 168]). CONCLUSION: Although there has been a notable increase in the proportion of women principal investigators over time, the overall representation remains relatively low. The disparities observed in trial characteristics and geographic distribution of women principal investigators further emphasize the need for targeted interventions and policies to foster a more inclusive and diverse environment in clinical trial leadership. CLINICAL RELEVANCE: These results underscore the importance of adopting practices and strategies that foster gender equity in the leadership of orthopaedic clinical trials. By establishing mentorship and sponsorship programs, early-career women surgeons can be connected with experienced leaders, cultivating a supportive network and offering valuable career guidance. Additionally, addressing geographic disparities in the representation of women principal investigators can involve the implementation of mentorship and sponsorship programs in regions with lower representation.

15.
J Arthroplasty ; 38(12): 2644-2649, 2023 12.
Article in English | MEDLINE | ID: mdl-37301238

ABSTRACT

BACKGROUND: The purpose of this study was to assess the odds of developing medical and surgical adverse events following total hip arthroplasty (THA) in patients who have a history of radiation therapy (RT) for cancer. METHODS: A retrospective cohort study was conducted using a national database to identify patients who underwent primary THA (Current Procedural Terminology code 27130) from 2002 to 2022. Patients who had a prior RT were identified by International Classification of Diseases, Tenth Revision, Clinical Modification codes Z51.0 (encounter for antineoplastic RT), Z92.3 (personal history of irradiation), or Current Procedural Terminology code 101843 (radiation oncology treatment). One-to-one propensity score matching was conducted to generate 3 pairs of cohorts: 1) THA with/without a history of RT; 2) THA with/without a history of cancer; and 3) THA patients who have a history of cancer treated with/without RT. Surgical and medical complications were assessed at the 30-day, 90-day, and 1-year postoperative periods. RESULTS: Patients who have a history of RT had higher odds of developing anemia, deep vein thrombosis, pneumonia, pulmonary embolism, and prosthetic joint infection at all intervals. When controlling for a history of cancer, RT was associated with an increased risk of pulmonary embolism, heterotrophic ossification, prosthetic joint infection, and periprosthetic fracture at all postoperative time points. There was additionally an increased risk of aseptic loosening at 1 year (odds ratio: 2.0, 95% confidence interval: 1.2 to 3.1). CONCLUSION: These findings suggest that patients who have a history of antineoplastic RT are at an increased risk of developing various surgical and medical complications following THA.


Subject(s)
Antineoplastic Agents , Arthroplasty, Replacement, Hip , Neoplasms , Pulmonary Embolism , Humans , Arthroplasty, Replacement, Hip/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Retrospective Studies , Risk Factors , Pulmonary Embolism/etiology , Neoplasms/complications , Reoperation/adverse effects
16.
J Arthroplasty ; 38(12): 2724-2730, 2023 12.
Article in English | MEDLINE | ID: mdl-37276950

ABSTRACT

BACKGROUND: With continued declines in reimbursement for total joint arthroplasty, health systems have explored implant cost containment measures to generate sustainable margins. This review evaluated how implementation of (1) implant price control programs, (2) vendor purchasing agreements, and (3) bundled payment models affected implant costs and physician autonomy in implant selection. METHODS: PubMed, EBSCOhost, and Google Scholar were searched to identify studies that evaluated the efficacy of total hip or total knee arthroplasty implant selection strategies. The review included publications between January 1, 2002, and October 17, 2022. The mean Methodological Index for Nonrandomized Studies score was 18.3 ± 1.8. RESULTS: A total of 13 studies (32,197 patients) were included. All studies implementing implant price capitation programs found decreased implant costs, ranging 2.2 to 26.1% and increased utilization of premium implants. Most studies found bundled payments models reduced total joint arthroplasty implant costs with greatest reduction being 28.9%. Additionally, while absolute single vendor agreements had higher implant costs, preferred single vendor agreements had reduced implant costs. When given price constraints, surgeons tended to select more premium implants. CONCLUSION: Alternative payment models that incorporated implant selection strategies saw reduced costs and surgeon utilization of premium implants. The study findings encourage further research on implant selection strategies, which must balance the goals of cost containment with physician autonomy and optimized patient care. LEVEL OF EVIDENCE: Level III.


Subject(s)
Arthroplasty, Replacement, Hip , Arthroplasty, Replacement, Knee , Joint Prosthesis , Surgeons , Humans , United States , Cost Control
17.
J Bone Joint Surg Am ; 105(19): 1551-1559, 2023 10 04.
Article in English | MEDLINE | ID: mdl-37224236

ABSTRACT

BACKGROUND: Clinical trials play a crucial role in advancing medical knowledge and have the potential to change standards of care. The present study evaluated the prevalence of discontinued clinical trials in orthopaedic surgery. Additionally, we sought to identify the study characteristics associated with and the rationale behind trial discontinuation. METHODS: A cross-sectional survey of orthopaedic clinical trials using the ClinicalTrials.gov registry and results database was performed for trials between October 1, 2007, and October 7, 2022. Interventional trials listed as "completed," "terminated," "withdrawn," or "suspended" were included. Study characteristics were collected and clinical trial abstracts were reviewed in order to assign the appropriate subspecialty category. A univariate linear regression analysis was performed to determine whether the percentage of discontinued trials changed between 2008 and 2021. Univariate and multivariable hazard ratios (HRs) were calculated to identify factors associated with trial discontinuation. RESULTS: A total of 8,603 clinical trials were included in the final analysis, of which 1,369 (16%) were discontinued, with the highest rates of discontinuation found in oncology (25%) and trauma (23%). The most common rationales for discontinuation were insufficient patient accrual (29%), technical or logistical issues (9%), business decision (9%), and lack of funding or resources (9%). Industry-funded studies were more likely than government-funded studies to be discontinued (HR: 1.81; p < 0.001). There was no change in the percentage of discontinued trials for each orthopaedic subspecialty between 2008 and 2021 (p = 0.21). As shown on multivariable regression analysis, trials for devices (HR: 1.63 [95% confidence interval, 1.20 to 2.21]; p = 0.002) and drugs (HR: 1.48 [1.10 to 2.02]; p = 0.013) as well as Phase-2 trials (HR: 1.35 [1.09 to 1.69]; p = 0.010), Phase-3 trials (HR: 1.39 [1.09 to 1.78]; p = 0.010), and Phase-4 trials (HR: 1.44 [1.14 to 1.81]; p = 0.010) had a higher likelihood of early discontinuation. However, pediatric trials were less likely to be discontinued (HR: 0.58 [0.40 to 0.86]; p = 0.007). CONCLUSIONS: The results of the present study suggest the need for continued efforts to ensure the completion of orthopaedic clinical trials in order to limit publication bias and to employ resources and patient contributions more efficiently for research. CLINICAL RELEVANCE: Discontinued trials contribute to publication bias, which limits the comprehensiveness of the literature available to support evidence-based patient care interventions. Therefore, identifying the factors associated with and the prevalence of orthopaedic trial discontinuation encourages orthopaedic surgeons to design future trials to be more resistant to early discontinuation.


Subject(s)
Orthopedic Procedures , Orthopedics , Child , Humans , Cross-Sectional Studies , Publication Bias , Research Design , Clinical Trials as Topic
18.
J Robot Surg ; 17(5): 2073-2079, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37209355

ABSTRACT

Accurate acetabular cup position remains a persistent challenge in total hip arthroplasty (THA). Studies investigating the early outcomes of robotic-assisted THA (RA-THA) systems have shown improved cup placement compared to manual THA (mTHA) approaches, however, contemporary robotic platforms are reliant on pre-operative CT imaging. The goal of this study was to analyze the accuracy of a novel, fluoroscopy-based RA-THA system compared to an unassisted mTHA approach and determine the effect of the robotic system on operative time. We performed a retrospective cohort analysis on a consecutive series of 198 patients who received mTHA and RA-THA between March 2021 and July 2022. The primary outcome of interest was the accuracy of acetabular component placement, defined by average cup inclination and anteversion. Secondary outcomes included the proportion of acetabular cups positioned within the Lewinnek safe zone, operative time, and overall room time. The RA-THA group demonstrated significantly higher accuracy of acetabular anteversion to target compared to the manual group (18.5 vs. 21.7˚; p < 0.001), and had a significantly greater proportion of acetabular cups placed within the Lewinnek safe zone (81.6 vs. 59.0%; p < 0.001). The RA-THA cohort had longer operative times compared to mTHA group (39.0 vs. 35.3 min; p = 0.003), but no difference was seen in total operating room time (101.2 vs. 101.2 min; p = 0.982). This study demonstrates that the use of a novel, fluoroscopy-based, pin-less THA robotic platform increased the accuracy of acetabular cup placement, including a 22.6% improvement in safe zone placement, compared to mTHA approach, with no increase in overall case time.


Subject(s)
Arthroplasty, Replacement, Hip , Robotic Surgical Procedures , Humans , Arthroplasty, Replacement, Hip/methods , Robotic Surgical Procedures/methods , Retrospective Studies , Treatment Outcome , Fluoroscopy
19.
Clin Orthop Relat Res ; 481(10): 1907-1916, 2023 10 01.
Article in English | MEDLINE | ID: mdl-37043552

ABSTRACT

BACKGROUND: Advanced practice professionals, including physician assistants (PAs) and nurse practitioners (NPs), play an important role in providing high-quality orthopaedic care. This role has been highlighted by projections of nationwide shortages in orthopaedic surgeons, with rural areas expected to be most affected. Given that approximately half of rural counties have no practicing orthopaedic surgeons and that advanced practice professionals have been shown to be more likely to practice in rural areas compared to physicians in other medical disciplines, orthopaedic advanced practice professionals may be poised to address orthopaedic care shortages in rural areas, but the degree to which this is true has not been well characterized. QUESTIONS/PURPOSES: (1) What percentage of rural counties have no orthopaedic caregivers, including surgeons and advanced practice professionals? (2) Is the density of advanced practice professionals greater than that of orthopaedic surgeons in rural counties? (3) Do orthopaedic advanced practice professionals only practice in counties that also have practicing orthopaedic surgeons? (4) Are NPs in states with full practice authority more likely to practice in rural counties compared with NPs in restricted practice authority states? METHODS: We identified orthopaedic surgeons and advanced practice professionals using the 2019 Medicare Provider Utilization and Payment Data, as this large dataset has been shown to be the most complete source of claims data nationwide. Each professional's ZIP Code was matched to counties per the US Postal Service ZIP Code Crosswalk Files. The total number and density of physician and advanced practice professionals per 100,000 residents were calculated per county nationwide. Counties were categorized as urban (large central metropolitan, large fringe metropolitan, medium metropolitan, and small metropolitan) or rural (micropolitan and noncore) using the National Center for Health Statistics Urban-Rural Classification Scheme. Comparisons between rural and urban county caregivers were conducted with the chi-square test and odds ratios. Population densities were compared with the Wilcoxon rank sum test. A bivariate density map was made to visualize the nationwide distribution of orthopaedic caregivers and determine the percentage of rural counties with no orthopaedic caregivers as well as whether orthopaedic advanced practice professionals practiced in counties not containing any surgeons. Additionally, to compare states with NP's full versus restricted practice authority, each NP was grouped based on their state to determine whether NPs in states with full practice authority were more likely to practice in rural counties. We identified a group of 31,091 orthopaedic caregivers, which was comprised of 23,728 physicians, 964 NPs, and 6399 PAs (7363 advanced practice professionals). A total of 88% (20,879 of 23,728) of physicians and 87% (6427 of 7363) of advanced practice professionals were in urban counties, which is comparable to nationwide population distributions. RESULTS: A total of 39% (1237 of 3139) of counties had no orthopaedic professionals (defined as orthopaedic surgeons or advanced practice professionals) in 2019. Among these counties, 82% (1015 of 1237) were rural and 18% (222 of 1237) were urban. The density of advanced practice professionals providing orthopaedic services compared with the density of orthopaedic surgeons was higher in rural counties (18 ± 70 versus 8 ± 40 per 100,000 residents; p = 0.001). Additionally, 3% (57 of 1974) of rural and 1% (13 of 1165) of urban counties had at least one orthopaedic advanced practice professional, but no orthopaedic surgeons concurrently practicing in the county. There was no difference between the percentage of rural counties with an NP in states with full versus restricted practice authority for NPs (19% [157 of 823] versus 26% [36 of 141], OR 1.45 [95% CI 0.99 to 2.2]; p = 0.08). CONCLUSION: As advanced practice professionals tended to only practice in counties which contain orthopaedic surgeons, our analysis suggests that plans to increase the number of advanced practice professionals alone in rural counties may not be sufficient to fully address the demand for orthopaedic care in rural areas that currently do not have orthopaedic surgeons in practice. Rather, interventions are needed to encourage more orthopaedic surgeons to practice in rural counties in collaborative partnerships with advanced practice professionals. In turn, rural orthopaedic advanced practice professionals may serve to further extend the accessibility of these surgeons, but it remains to be determined what the total number and ratio of advanced practice professionals and surgeons is needed to serve rural counties adequately. CLINICAL RELEVANCE: To increase rural orthopaedic outreach, state legislatures may consider providing financial incentives to hospitals who adopt traveling clinic models, incorporating advanced practice professionals in these models as physician-extenders to further increase the coverage of orthopaedic care. Furthermore, the creation of more widespread financial incentives and programs aimed at expanding the experience of trainees in serving rural populations are longer-term investments to foster interest and retention of orthopaedic caregivers in rural settings.


Subject(s)
Orthopedic Surgeons , Surgeons , Aged , Humans , United States , Medicare , Rural Population , Quality of Health Care
20.
Int J Med Robot ; 19(4): e2518, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37058696

ABSTRACT

BACKGROUND: Adoption of robotic-assisted total hip arthroplasty (RA-THA) systems can improve the accuracy of acetabular cup placement, but no group has reported the learning curve of novel, fluoroscopy-based RA-THA systems. METHODS: A learning-curve cumulative summation (LC-CUSUM) analysis was performed on a consecutive series of the first 100 patients who received fluoroscopy-based RA-THA by the study surgeon. Operative times and specific robotic timepoints were compared between learning and proficiency phases. RESULTS: Implementation of fluoroscopy-based RA-THA was associated with a learning curve of 12 cases. A 6-min increase in operative time was seen during the learning phase compared to the proficiency phase (44.3 ± 4.4 vs. 38.0 ± 7.1 min; p < 0.001), with a 3-min longer robotic cup impaction sequence during the learning phase (7.8 ± 1.9 vs. 4.8 ± 1.3 min; p < 0.001). CONCLUSION: Adoption of fluoroscopy-based RA-THA is associated with a brief learning curve of 12 cases, with the most significant improvements in surgical efficiency realised during acetabular cup placement.


Subject(s)
Arthroplasty, Replacement, Hip , Hip Prosthesis , Robotic Surgical Procedures , Humans , Learning Curve , Acetabulum/diagnostic imaging , Acetabulum/surgery , Fluoroscopy , Retrospective Studies
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