Navigating the learning curve: assessing caseload and comparing outcomes before and after the learning curve of computer-navigated total hip arthroplasty.

PURPOSE: Computer-navigated (CN) 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 a novel platform challenging. Therefore, we conducted a systematic review to assess the learning curve associated with CN-THA, both tracking a surgeon's performance across initial cases and comparing their performance to manual THA (M-THA). METHODS: A search was conducted using PubMed, MEDLINE, EBSCOhost, and Google Scholar on June 16, 2023 to find research articles published after January 1, 2000 (PROSPERO registration: CRD4202339403) that investigated the learning curve associated with CN-THA. 655 distinct articles were retrieved and subsequently screened for eligibility. In the final analysis, nine publications totaling 847 THAs were evaluated. The Methodological Index for Nonrandomized Studies (MINORS) tool was utilized to evaluate the potential for bias, with the mean MINORS score of 21.3 ± 1.2. RESULTS: CN-THA showed early advantages to M-THA for component placement accuracy and radiographic outcomes but longer operative times (+ 3- 20 min). There was a learning curve required to achieve peak proficiency in these metrics, though mixed methodologies made the required caseload unclear. CONCLUSIONS: CN-THA offers immediate advantages to M-THA for component placement accuracy and radiographic outcomes, though CN-THA's advantages become more pronounced with experience. Surgeons should anticipate longer operative times during the learning curve for CN-THA, which lessen following a modest caseload. A more thorough evaluation of novel computer-navigated technologies would be enhanced by adopting a more uniform method of defining learning curves for outcomes of interest. Registration PROSPERO registration of the study protocol: CRD42023394031, 27 June 2023.

Are orthopedic clinical trials representative? An analysis of race and ethnicity reported in clinical trials between 2007 and 2022 : Running title: representation of clinical trials in orthopedic surgery.

INTRODUCTION: Prior studies investigating the racial and ethnic representation of orthopedic trial participants have found low rates of reporting, but these studies are dated due to the passing of the National Institutes of Health Final Rule in 2017 requiring the reporting of racial and ethnic data among clinical trials. Therefore, we evaluated the representativeness of orthopedic clinical trials before and after the Final Rule. METHODS: A cross-sectional survey of orthopaedic clinical trials registered at ClinicalTrials.gov between October 1, 2007 and May 20, 2023 was conducted. After identifying and screening 23,752 clinical trials, 1564 trials were included in the analysis. Trials started before the implementation of the Final Rule on January 18, 2017 were grouped and compared to trials that began after. Odds ratios (OR) were utilized to identify trial characteristics associated with reporting race/ethnicity data. One-proportion z tests compared the representation of each racial and ethnic category to the 2020 United States Census. RESULTS: In total, 34% (544 of 1564) of orthopedic clinical trials evaluated reported the race of participants, while 28% (438 of 1564) reported ethnicity. Trials registered after the Final Rule were more likely to report racial (OR: 5.15, 95%CI: 3.72-7.13, p < 0.001) and ethnic (OR: 3.23, 95%CI: 2.41-4.33, p < 0.001) representation of participants. Compared with the distribution of race and ethnicity reported by the United States 2020 Census, orthopedic trials had 16.6% more White participants (95% CI 16.4%, 16.8%; p < 0.001), 3.2% fewer Black participants (95%CI 3.1%, 3.3%; p < 0.001), and 5.7% fewer Hispanic/Latino participants (95%CI 5.2%, 6.2%; p < 0.001). Trials with enrollment sizes over 100 participants were also more likely to report race and ethnicity, with odds increasing with increased sample size. CONCLUSIONS: The Final Rule marginally improved the reporting of race and ethnicity in orthopedic clinical trials, and underrepresentation of Black or African American, Multiracial, and Hispanic populations persists. LEVEL OF EVIDENCE: III.

Photodynamic bone stabilization for traumatic and pathologic fractures: a systematic review of utilization, complications, and patient-reported outcomes.

INTRODUCTION: The photodynamic bone stabilization system (PBSS) was was developed in 2010, and in 2018 gained FDA approval in the United States. Given its relative novelty, our analysis sought to analyze the available literature exploring the indications, outcomes, and complications of the PBSS. METHODS: We performed a systematic review (PROSPERO registration of study protocol: CRD42022363065, October 8th, 2022). PubMed, EBSCOHost, and Google Scholar electronic databases were queried to identify articles evaluating PBSS in the treatment of pathologic or traumatic fractures between January 1 2010 and 15 October 2022. The quality of the included studies was assessed using the Methodological Index for Nonrandomized Studies tool. RESULTS: Our initial search yielded 326 publications, which were then screened for appropriate studies that aligned with the purpose of our review. A total of thirteen studies, comprising seven case series, four case reports, and two cohort studies. The total sample size of the included studies consisted of 345 patients, with 242 females (70%) and 103 males (30%). The implants were most commonly utilized in the humerus (41%), radius (12%), and metacarpal (12%). The most common complications were related to broken implants (5%) and dislocation (1%). Most studies reported complete fracture healing and return of full strength and range of motion. CONCLUSION: Despite being a relatively novel technology, PBSS appears to be a viable option for fracture stabilization. Most studies included in our analysis reported complete fracture healing and return of function with minimal complications.

Use of a fluoroscopy-based robotic-assisted total hip arthroplasty system produced greater improvements in patient-reported outcomes at one year compared to manual, fluoroscopic-assisted technique.

INTRODUCTION: The adoption of new technology should be supported by improvements in patient-reported outcomes (PROMs). The purpose of this study was to assess the one-year PROMs of patients who underwent total hip arthroplasty (THA) using a novel, fluoroscopy-based, robotic-assisted (RA-THA) system when compared to a manual, fluoroscopic-assisted technique (mTHA). MATERIALS AND METHODS: A review of 91 consecutive mTHA and 85 consecutive RA-THA via a direct anterior approach was conducted. All cases were performed by the same surgeon at the same institution, for a pre-operative diagnosis of osteoarthritis, avascular necrosis, or rheumatoid arthritis. Outcomes included one-year Veterans RAND-12 (VR-12) Physical/Mental, Hip Disability and Osteoarthritis Outcome (HOOS) Pain/Physical Function/Joint Replacement, and University of California Los Angeles (UCLA) Activity scores, as well as the difference between pre-operative and one-year post-operative PROMs. RESULTS: Patients in the RA-THA cohort had lower pre-operative HOOS-JR scores compared to patients in the mTHA cohort (37.0 vs. 43.1; p = 0.031). Cohorts experienced similar one-year post-operative VR-12, HOOS, and UCLA Activity scores. Patients in the RA-THA cohort experienced greater improvements across all pre- and post-operative HOOS scores compared to patients in the mTHA cohort: Pain (+ 54.7 vs. +42.1; p = 0.009), Physical Function (-41.6 vs. -28.7; p = 0.007), and Joint Replacement (+ 46.6 vs. +33.0; p = 0.002). These differences exceeded minimum clinically important difference (MCID). CONCLUSIONS: Both manual and robotic cohorts experienced benefit from THA at one-year post-operative. Importantly, the use of a novel, fluoroscopy-based robotic assistance system for primary THA resulted in greater improvements in PROMs at one-year relative to manual technique.

Fluoroscopy-based robotics in total hip arthroplasty mitigates laterality-based differences in acetabular cup placement when compared to the manual, fluoroscopic- assisted technique.

BACKGROUND: Robotic assistance in total hip arthroplasty (RA-THA) has been shown to minimize laterality-based differences in acetabular cup positioning. OBJECTIVE: To determine if the use of a novel, fluoroscopy-based RA-THA system mitigates differences in acetabular cup placement between left (L) and right (R) side hip procedures, when compared to manual, fluoroscopic-assisted technique. METHODS: We conducted a retrospective review of 106 consecutive mTHA (40 L/66 R) and 102 RA-THA (48 L/54 R) primary direct anterior approach procedures. All cases were performed by a single right-hand-dominant surgeon, for a pre-operative diagnosis of osteoarthritis, avascular necrosis, or rheumatoid arthritis. Outcomes included acetabular cup inclination and anteversion, and the proportion of cups within the Lewinnek safe-zone. RESULTS: The average inclination of mTHA L cases was smaller than that of mTHA R cases (41.10∘± 7.38 vs. 43.97∘± 6.27; p= 0.04). For RA-THA, L and R cup angles were similar. There were fewer overall mTHA hips within the Lewinnek safe-zone compared to RA-THA (0.59 vs. 0.78; p= 0.003), as well as fewer mTHA R cases than RA-THA R cases (0.59 vs. 0.80; p= 0.03) within safe zone. CONCLUSION: Use of a novel, fluoroscopy-based robotic system mitigates laterality-based differences in acetabular cup placement that were observed in a manual, fluoroscopic-assisted cohort.

Fluoroscopy-based robotic assistance for total hip arthroplasty improves acetabular cup placement accuracy for obese patients compared to the manual, fluoroscopic- assisted technique.

BACKGROUND: Patient obesity is a risk factor for poor acetabular cup positioning in total hip arthroplasty (THA). OBJECTIVE: To assess the impact of using a novel, fluoroscopy-based robotic THA system on acetabular cup placement in obese versus non-obese patients. METHODS: A review of 105 consecutive manual unassisted (mTHA) (47 Obese/58 Non-obese) and 102 robotic-assisted (RA-THA) (50 Obese/52 Non-obese) primary, direct anterior approach THA procedures was conducted. All cases were performed by a single surgeon, for a pre-operative diagnosis of osteoarthritis, avascular necrosis, or rheumatoid arthritis. Obesity was defined as a Body Mass Index (BMI) ⩾ 30 kg/m2. Outcomes included acetabular cup inclination and anteversion, and the proportion of cups within the Lewinnek safe-zone. RESULTS: Obese patients in the mTHA cohort had larger cup inclination angles on average compared to non-obese patients (44.82∘± 6.51 vs. 41.39∘± 6.75; p= 0.009). Obese mTHA patients were less likely to have cup placement within the Lewinnek zone compared to non-obese mTHA patients (0.48 vs. 0.67; p= 0.027). Obesity had no effect on the accuracy of RA-THA. CONCLUSION: Obesity affects the placement of the acetabular component in manual THA. The novel, fluoroscopy-based robotic THA system in this study demonstrated accurate cup placement regardless of obesity status.

Robotic-assisted total hip arthroplasty utilizing a fluoroscopy-guided system resulted in improved intra-operative efficiency relative to a computerized tomography-based platform.

Robotic-assisted total hip arthroplasty (THA) using a computerized-tomography (CT) based workflow increases surgical time relative to traditional manual technique. The purpose of this investigation was to compare the intra-operative efficiencies of two robotic THA systems: a fluoroscopy-based platform (FL-RTHA) and a contemporary, CT-based (CT-RTHA) platform. A review of 107 consecutive FL-RTHA and 159 CT-RTHA primary, direct anterior approach (DAA) THA procedures was conducted. All cases were performed by one of two surgeons operating at the same institution, for a pre-operative diagnosis of osteoarthritis, avascular necrosis, or rheumatoid arthritis. Primary outcome variables included averages and consistencies (variances) for surgical times and operating room (OR) times. A secondary outcome was to quantify the duration of robot-active phases in the FL-RTHA workflow. The FL-RTHA cohort experienced shorter surgical times (38.71 min ± 7.00 vs. 75.33 min ± 11.38; p < 0.001) and OR times (101.35 min ± 12.22 vs. 156.74 min ± 17.79; p < 0.001) compared to the CT-RTHA cohort. Surgical times and OR times were both more consistent in the FL-RTHA cohort compared to the CT-RTHA cohort (p < 0.001). Patients who underwent DAA THA with the assistance of a fluoroscopy-based robotic system experienced shorter and more consistent surgical times and OR times compared to patients who underwent similar DAA THA procedures with a contemporary, CT-based robotic platform.