Kevin K Kang,Lucas Voyvodic,Daniel Komlos,Samuel Swiggett,Mitchell K Ng
{"title":"Liposomal Bupivacaine Does Not Decrease Postoperative Pain in Patients with Intracapsular Femoral Neck Fracture Treated with Hemiarthroplasty: HEAT-A Randomized, Controlled Trial.","authors":"Kevin K Kang,Lucas Voyvodic,Daniel Komlos,Samuel Swiggett,Mitchell K Ng","doi":"10.2106/jbjs.23.01344","DOIUrl":"https://doi.org/10.2106/jbjs.23.01344","url":null,"abstract":"BACKGROUNDLiposomal bupivacaine (LB) is a long-lasting local anesthetic agent that was developed for use in the surgical setting to help manage postoperative pain. The objective of this study was to evaluate the effect of LB on postoperative pain, function, and overall hospital course in patients with intracapsular hip fractures who were treated with hip hemiarthroplasty.METHODSThis was a single-center, randomized prospective double-blinded study of 50 patients with an isolated intracapsular femoral neck fracture who were treated with hip hemiarthroplasty from 2018 to 2022. The study group consisted of 25 patients who were treated with intraoperative LB and bupivacaine hydrochloride injections, while the control group consisted of 25 patients who were treated with intraoperative bupivacaine hydrochloride injections only. Primary outcomes were a visual analog scale (VAS) score for pain, total morphine milligram equivalents (MME), delirium, and time to ambulation with physical therapy.RESULTSNo significant differences between the study and control groups were found in any of the outcomes measured. Most notably, there were no differences in the average postoperative pain score (VAS, 2.26 versus 2.7; p = 0.34), total MME used postoperatively (11.73 versus 9.98 MME; p = 0.71), and postoperative day of discharge (4.00 versus 3.88 days; p = 0.82).CONCLUSIONSThe results of our study suggest that use of LB is not associated with substantially improved postoperative pain or function or with a shorter hospital course following hip hemiarthroplasty for a femoral neck fracture. Given the higher cost of LB compared with standard postoperative pain modalities, it is worth questioning its use in the setting of geriatric hip fractures.LEVEL OF EVIDENCETherapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.","PeriodicalId":22625,"journal":{"name":"The Journal of Bone & Joint Surgery","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142246904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Don't Just Stand There; Do Something: Commentary on an article by Braeden Benedict, MS, et al.: \"Using Multimodal Assessments to Reevaluate Depression Designations for Spine Surgery Candidates\".","authors":"James B Talmage,Les P Kertay","doi":"10.2106/jbjs.24.00578","DOIUrl":"https://doi.org/10.2106/jbjs.24.00578","url":null,"abstract":"","PeriodicalId":22625,"journal":{"name":"The Journal of Bone & Joint Surgery","volume":"8 1","pages":"e40"},"PeriodicalIF":0.0,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142273526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kan-Lin Hung,Yong Lu,Yinglun Tian,Shilin Xue,Guodong Gao,Qiyue Gao,Nanfang Xu,Shenglin Wang
{"title":"Minimally Invasive Surgery for Posterior Atlantoaxial Lateral Mass Joint Fusion (MIS-PALF): A Muscle-Sparing Procedure for Atlantoaxial Instability or Dislocation.","authors":"Kan-Lin Hung,Yong Lu,Yinglun Tian,Shilin Xue,Guodong Gao,Qiyue Gao,Nanfang Xu,Shenglin Wang","doi":"10.2106/jbjs.23.01464","DOIUrl":"https://doi.org/10.2106/jbjs.23.01464","url":null,"abstract":"BACKGROUNDConventional surgical procedures for atlantoaxial instability or dislocation (AAI/D) have been associated with a high prevalence of postoperative occipitocervical pain and dysfunction, as well as substantial perioperative blood loss. We hypothesized that minimally invasive surgery for posterior atlantoaxial lateral mass joint fusion (MIS-PALF), a procedure that can largely avoid disruption of suboccipital musculature, would be superior to the standard Goel-Harms technique in terms of postoperative pain and perioperative blood loss.METHODSThis was a prospective cohort study of patients undergoing MIS-PALF for AAI/D at Peking University Third Hospital's Department of Orthopaedics from January 2021 to December 2021 and a historical control group of patients with the same diagnoses who were treated with the Goel-Harms technique. The duration of surgery, perioperative blood loss, postoperative length of hospital stay, postoperative body temperature, pain, supplementary use of narcotics, spinal cord function/improvement (assessed using the Japanese Orthopaedic Association [JOA] scores), reduction of AAI/D (determined based on radiographic parameters), rate of successful fusion, and complication rate were all compared between the 2 groups.RESULTSNo significant differences were noted between the groups (43 MIS-PALF cases, 86 control cases) regarding baseline data, operative time, spinal cord function or improvement, reduction of AAI/D, rate of successful fusion, and complication rate. MIS-PALF was associated with significantly less perioperative blood loss, a shorter postoperative hospital stay (decreased by 30.8%), lower intensity and frequency of postoperative pain (decreased by 10.6% and 61.9%, respectively), less need for supplementary narcotics, and less frequent postoperative fever (decreased by 48.7%).CONCLUSIONSThis was the first prospective cohort study of which we are aware on minimally invasive procedures for atlantoaxial fusion. Clinical efficacy (AAI/D reduction, rate of successful atlantoaxial fusion, JOA score improvement), efficiency (operative time), and safety (complications) of MIS-PALF appeared to be noninferior to those of the Goel-Harms technique. MIS-PALF was superior in terms of postoperative occipitocervical pain and length of hospital stay, both of which directly affect overall patient satisfaction and postoperative recovery of quality of life.LEVEL OF EVIDENCETherapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.","PeriodicalId":22625,"journal":{"name":"The Journal of Bone & Joint Surgery","volume":"196 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142246905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jeffrey Hills,Gregory M Mundis,Eric O Klineberg,Justin S Smith,Breton Line,Jeffrey L Gum,Themistocles S Protopsaltis,D Kojo Hamilton,Alex Soroceanu,Robert Eastlack,Pierce Nunley,Khaled M Kebaish,Lawrence G Lenke,Richard A Hostin,Munish C Gupta,Han Jo Kim,Christopher P Ames,Douglas C Burton,Christopher I Shaffrey,Frank J Schwab,Virginie Lafage,Renaud Lafage,Shay Bess,Michael P Kelly,
{"title":"The T4-L1-Hip Axis: Sagittal Spinal Realignment Targets in Long-Construct Adult Spinal Deformity Surgery: Early Impact.","authors":"Jeffrey Hills,Gregory M Mundis,Eric O Klineberg,Justin S Smith,Breton Line,Jeffrey L Gum,Themistocles S Protopsaltis,D Kojo Hamilton,Alex Soroceanu,Robert Eastlack,Pierce Nunley,Khaled M Kebaish,Lawrence G Lenke,Richard A Hostin,Munish C Gupta,Han Jo Kim,Christopher P Ames,Douglas C Burton,Christopher I Shaffrey,Frank J Schwab,Virginie Lafage,Renaud Lafage,Shay Bess,Michael P Kelly,","doi":"10.2106/jbjs.23.00372","DOIUrl":"https://doi.org/10.2106/jbjs.23.00372","url":null,"abstract":"BACKGROUNDOur understanding of the relationship between sagittal alignment and mechanical complications is evolving. In normal spines, the L1-pelvic angle (L1PA) accounts for the magnitude and distribution of lordosis and is strongly associated with pelvic incidence (PI), and the T4-pelvic angle (T4PA) is within 4° of the L1PA. We aimed to examine the clinical implications of realignment to a normal L1PA and T4-L1PA mismatch.METHODSA prospective multicenter adult spinal deformity registry was queried for patients who underwent fixation from the T1-T5 region to the sacrum and had 2-year radiographic follow-up. Normal sagittal alignment was defined as previously described for normal spines: L1PA = PI × 0.5 - 21°, and T4-L1PA mismatch = 0°. Mechanical failure was defined as severe proximal junctional kyphosis (PJK), displaced rod fracture, or reoperation for junctional failure, pseudarthrosis, or rod fracture within 2 years. Multivariable nonlinear logistic regression was used to define target ranges for L1PA and T4-L1PA mismatch that minimized the risk of mechanical failure. The relationship between changes in T4PA and changes in global sagittal alignment according to the C2-pelvic angle (C2PA) was determined using linear regression. Lastly, multivariable regression was used to assess associations between initial postoperative C2PA and patient-reported outcomes at 1 year, adjusting for preoperative scores and age.RESULTSThe median age of the 247 included patients was 64 years (interquartile range, 57 to 69 years), and 202 (82%) were female. Deviation from a normal L1PA or T4-L1PA mismatch in either direction was associated with a significantly higher risk of mechanical failure, independent of age. Risk was minimized with an L1PA of PI × 0.5 - (19° ± 2°) and T4-L1PA mismatch between -3° and +1°. Changes in T4PA and in C2PA at the time of final follow-up were strongly associated (r2 = 0.96). Higher postoperative C2PA was independently associated with more disability, more pain, and worse self-image at 1 year.CONCLUSIONSWe defined sagittal alignment targets using L1PA (relative to PI) and the T4-L1PA mismatch, which are both directly modifiable during surgery. In patients undergoing long fusion to the sacrum, realignment based on these targets may lead to fewer mechanical failures.LEVEL OF EVIDENCETherapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.","PeriodicalId":22625,"journal":{"name":"The Journal of Bone & Joint Surgery","volume":"64 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142246907","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mina Tohidi,George Grammatopoulos,Stephen M Mann,Alexandra Pysklywec,Patti A Groome
{"title":"Patient Factors Associated with 10-Year Survival After Arthroplasty for Hip Fracture: A Population-Based Study in Ontario, Canada.","authors":"Mina Tohidi,George Grammatopoulos,Stephen M Mann,Alexandra Pysklywec,Patti A Groome","doi":"10.2106/jbjs.24.00379","DOIUrl":"https://doi.org/10.2106/jbjs.24.00379","url":null,"abstract":"BACKGROUNDThe aim of this study was to describe long-term (10-year) patient survival after arthroplasty for hip fracture and to determine what patient factors are associated with that outcome.METHODSWe performed a retrospective cohort analysis of patients ≥60 years old who underwent either hemiarthroplasty or total hip arthroplasty for femoral neck fracture between 2002 and 2009. We used routinely collected, validated health-care databases linked through ICES (formerly known as the Institute for Clinical Evaluative Sciences). We estimated the association between baseline variables and survival 10 years post-fracture using Poisson regression. Restricted cubic spline functions modeled the probability of 10-year survival by age and tested whether there was an inflection point after which the probability of 10-year survival decreased more rapidly. We estimated 10-year survival probabilities for different patient groups.RESULTSThere were 19,659 patients in the final cohort. Eighteen percent (3,564) of the patients were alive at 10 years postoperatively. Factors associated with a higher likelihood of 10-year survival included younger age, female sex (risk ratio [RR] = 1.56, 95% confidence interval [CI] = 1.46 to 1.68), lower American Society of Anesthesiologists (ASA) class (ASA I or II versus IV or V: RR = 1.96, 95% CI = 1.76 to 2.19), independent living status (RR = 2.68, 95% CI = 2.23 to 3.22), and fewer specific comorbidities. A threshold age of 73 years was the inflection point after which the probability of 10-year survival decreased more rapidly in females. Estimated 10-year survival probabilities ranged from 79.0% (95% CI = 75.5% to 82.5%) to 0.8% (95% CI = 0.6% to 1.0%).CONCLUSIONSApproximately 1 in 6 patients live at least 10 years following a hip fracture. This study identifies baseline characteristics that predict survival greater than 10 years, including an age of <75 years, an ASA class of I or II, and independent living status prior to the hip fracture. Results can inform discussions around treatment choices, anticipated outcomes, and the natural history of hip fractures.LEVEL OF EVIDENCEPrognostic Level III. See Instructions for Authors for a complete description of levels of evidence.","PeriodicalId":22625,"journal":{"name":"The Journal of Bone & Joint Surgery","volume":"75 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142246983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Janus Siu Him Wong,Evelyn Eugenie Kuong,Michael Kai Tsun To,Alfred Lok Hang Lee,Noah Lok Wah So,Wang Chow
{"title":"Prognosticating Residual Dysplasia at Skeletal Maturity Following Closed Reduction for Developmental Dysplasia of the Hip: A Long-Term Study with an Average 20-Year Follow-up.","authors":"Janus Siu Him Wong,Evelyn Eugenie Kuong,Michael Kai Tsun To,Alfred Lok Hang Lee,Noah Lok Wah So,Wang Chow","doi":"10.2106/jbjs.23.01484","DOIUrl":"https://doi.org/10.2106/jbjs.23.01484","url":null,"abstract":"BACKGROUNDPatients with developmental dysplasia of the hip (DDH) are at risk for residual acetabular dysplasia even after successful closed reduction. The aim of this study was to identify predictors of long-term outcomes in order to guide prognostication and management.METHODSPatients who were treated for DDH at 2 institutions between 1970 and 2010 and had follow-up until skeletal maturity were screened for inclusion. Hips that underwent open reduction were excluded to reduce iatrogenic confounding. Syndromal (including neuromuscular and arthrogrypotic) hip instability with collagenopathies were excluded. Demographic characteristics, Tönnis grade, age at the time of the reduction, surgical treatment, acetabular index, lateral center-edge angle, residual dysplasia graded using the Severin classification, and the presence and type of proximal femoral growth disturbance categorized using the Bucholz and Ogden classification were assessed. In addition, the the acetabular angle was recorded at the latest follow-up before secondary procedures, and the Oxford Hip Score and 5-level EuroQoL (EQ)-5 Dimension score were recorded at the latest follow-up. To account for repeated measures, generalized estimating equations (GEE) logistic regression was utilized for the multivariable analysis. A support vector machine model and a receiver operating characteristic curve analysis were utilized to identify prognostication thresholds.RESULTSOne hundred and seven hips (96 female, 11 male) that were followed to skeletal maturity, with a mean follow-up of 20 years (range, 10 to 54 years), were included in the analysis. Eighty-nine hips (83%) demonstrated a good outcome at skeletal maturity, with a Severin grade of I or II. Major growth disturbances of Bucholz and Ogden types II, III, or IV were present in 13 hips (12%). At the latest follow-up after skeletal maturity (before any secondary procedures), the mean acetabular angle was 45° ± 4° and the mean lateral center-edge angle was 26° ± 8°. The mean Oxford Hip Score and EQ visual analog scale values were 47 and 86, respectively. A GEE logistic regression analysis of 1,135 observations revealed that the acetabular index (odds ratio [OR], 1.16 per degree; p < 0.001) and age (OR, 1.20 per year; p = 0.003) were significant predictors of a poor outcome (i.e., Severin grade III, IV, or V). Significant differences in acetabular indices across all age groups were found between hips with a good outcome and those with a poor outcome. Age-specific acetabular index prognostication cutoff values are presented.CONCLUSIONSThis long-term follow-up study demonstrated that the age-specific acetabular index remains an important predictor of residual dysplasia at skeletal maturity. The proposed prognostication chart and thresholds herein can help to guide orthopaedic surgeons and parents when contemplating the use of an intervention versus surveillance to optimize long-term outcomes.LEVEL OF EVIDENCEPrognostic Level III. See Instruction","PeriodicalId":22625,"journal":{"name":"The Journal of Bone & Joint Surgery","volume":"7 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142246908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michael R Moore,Brittany DeClouette,Isabel Wolfe,Matthew T Kingery,Carlos Sandoval-Hernandez,Ryan Isber,Thorsten Kirsch,Eric J Strauss
{"title":"Levels of Synovial Fluid Inflammatory Biomarkers on Day of Arthroscopic Partial Meniscectomy Predict Long-Term Outcomes and Conversion to TKA: A 10-Year Mean Follow-up Study.","authors":"Michael R Moore,Brittany DeClouette,Isabel Wolfe,Matthew T Kingery,Carlos Sandoval-Hernandez,Ryan Isber,Thorsten Kirsch,Eric J Strauss","doi":"10.2106/jbjs.23.01392","DOIUrl":"https://doi.org/10.2106/jbjs.23.01392","url":null,"abstract":"BACKGROUNDThe purpose of the present study was to evaluate the relationships of the concentrations of pro- and anti-inflammatory biomarkers in the knee synovial fluid at the time of arthroscopic partial meniscectomy (APM) to long-term patient-reported outcomes (PROs) and conversion to total knee arthroplasty (TKA).METHODSA database of patients who underwent APM for isolated meniscal injury was analyzed. Synovial fluid had been aspirated from the operatively treated knee prior to the surgical incision, and concentrations of pro- and anti-inflammatory biomarkers (RANTES, IL-6, MCP-1, MIP-1β, VEGF, TIMP-1, TIMP-2, IL-1RA, MMP-3, and bFGF) were quantified. Prior to surgery and again at the time of final follow-up, patients were asked to complete a survey that included a visual analog scale (VAS) for pain and Lysholm, Tegner, and Knee injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS) questionnaires. Clustering analysis of the 10 biomarkers of interest was carried out with the k-means algorithm.RESULTSOf the 82 patients who met the inclusion criteria for the study, 59 had not undergone subsequent ipsilateral TKA or APM, and 43 (73%) of the 59 completed PRO questionnaires at long-term follow-up. The mean follow-up time was 10.6 ± 1.3 years (range, 8.7 to 12.4 years). Higher concentrations of individual pro-inflammatory biomarkers including MCP-1 (β = 13.672, p = 0.017) and MIP-1β (β = -0.385, p = 0.012) were associated with worse VAS pain and Tegner scores, respectively. K-means clustering analysis separated the cohort of 82 patients into 2 groups, one with exclusively higher levels of pro-inflammatory biomarkers than the second group. The \"pro-inflammatory phenotype\" cohort had a significantly higher VAS pain score (p = 0.024) and significantly lower Lysholm (p = 0.022), KOOS-PS (p = 0.047), and Tegner (p = 0.009) scores at the time of final follow-up compared with the \"anti-inflammatory phenotype\" cohort. The rate of conversion to TKA was higher in the pro-inflammatory cohort (29.4% versus 12.2%, p = 0.064). Logistic regression analysis demonstrated that the pro-inflammatory phenotype was significantly correlated with conversion to TKA (odds ratio = 7.220, 95% confidence interval = 1.028 to 50.720, p = 0.047).CONCLUSIONSThe concentrations of synovial fluid biomarkers on the day of APM can be used to cluster patients into pro- and anti-inflammatory cohorts that are predictive of PROs and conversion to TKA at long-term follow-up.LEVEL OF EVIDENCEPrognostic Level III. See Instructions for Authors for a complete description of levels of evidence.","PeriodicalId":22625,"journal":{"name":"The Journal of Bone & Joint Surgery","volume":"30 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142231326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Thirty-five Years of Reporting of Sex and Race in Clinical Studies of U.S. FDA-Authorized Orthopaedic Devices.","authors":"Hongying Jiang,Katherine Kavlock,Qin Li,Shruti Mistry,Valerie Hermes,Alonza Gibbs,Elizabeth Adegboyega-Panox,Raquel Peat","doi":"10.2106/jbjs.24.00201","DOIUrl":"https://doi.org/10.2106/jbjs.24.00201","url":null,"abstract":"BACKGROUNDAt the U.S. Food and Drug Administration (FDA), the mission of the Center for Devices and Radiological Health (CDRH) is to ensure that all patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Although the CDRH has observed enrollment differences in some clinical trials, no systematic analysis has been conducted regarding enrollment differences in baseline demographics, to our knowledge.METHODSThe CDRH has summarized information on study participants and their baseline demographics in public-facing documentation for all authorized medical devices that involved orthopaedic clinical studies from 1985 to 2020. Descriptive analyses and exploratory statistical testing have been conducted to investigate the reported percentages by sex and race compared with those reported in the U.S. National Census and the American Joint Replacement Registry (AJRR), respectively.RESULTSWe identified 94 submissions and corresponding combined clinical trials from 261 original clinical study arms with 34,193 participants. Most of the submissions reported age and sex, while only 36 submissions (38.3%) reported racial demographics. Among the 88 trials providing enrollment by sex, the female enrollment percentage ranged from 22.2% to 88.7%, with a mean of 55.0%. In the submissions that reported racial data (38.3%), White and Black patients had a mean enrollment of 89.2% (range, 64.8% to 98.7%) and 6.2% (range, 0.4% to 20.7%), respectively. The enrollment for other minority groups ranged from 0% to 3.0%. These clinical trials have shown numerically lower female representation (55.0%) but higher White representation (89.2%) than what has been reported in the AJRR. The other racial groups have participated much less than their corresponding percentages in the U.S. population, but they are similarly represented in the AJRR.CONCLUSIONSThe clinical trials supporting the FDA's authorization of orthopaedic devices had a wide range of sex and racial enrollments. It appears that female enrollment mirrors the percentage of women in the U.S. population. However, despite prior efforts, some racial groups are still underrepresented. The FDA has made a commitment to advancing health equity as part of the 2022-2025 Strategic Priorities of the CDRH. We hope that the results of this study will help health-care professionals make informed clinical decisions when using medical devices.","PeriodicalId":22625,"journal":{"name":"The Journal of Bone & Joint Surgery","volume":"62 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142231331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dae-Woong Ham,Sang-Min Park,Youngbae B Kim,Dong-Gune Chang,Jae Jun Yang,Byung-Taek Kwon,Kwang-Sup Song
{"title":"Feasibility of the Non-Window-Type 3D-Printed Porous Titanium Cage in Posterior Lumbar Interbody Fusion: A Randomized Controlled Multicenter Trial.","authors":"Dae-Woong Ham,Sang-Min Park,Youngbae B Kim,Dong-Gune Chang,Jae Jun Yang,Byung-Taek Kwon,Kwang-Sup Song","doi":"10.2106/jbjs.23.01245","DOIUrl":"https://doi.org/10.2106/jbjs.23.01245","url":null,"abstract":"BACKGROUNDThree-dimensionally printed titanium (3D-Ti) cages can be divided into 2 types: window-type cages, which have a void for bone graft, and non-window-type cages without a void. Few studies have investigated the necessity of a void for bone graft in fusion surgery. Therefore, the present study assessed the clinical and radiographic outcomes of window and non-window-type 3D-Ti cages in single-level posterior lumbar interbody fusion.METHODSA total of 70 patients were randomly assigned to receive either a window or non-window cage; 61 patients (87%) completed final follow-up (32 from the window cage group, 29 from the non-window cage group). Radiographic outcomes, including fusion rates, subsidence, and intra-cage osseointegration patterns, were assessed. Intra-cage osseointegration was measured using the intra-cage bridging bone score for the window cage group and the surface osseointegration ratio score for the non-window cage group. Additionally, we looked for the presence of the trabecular bone remodeling (TBR) sign on computed tomography (CT) images.RESULTSOf the 61 patients, 58 achieved interbody fusion, resulting in a 95.1% fusion rate. The fusion rate in the non-window cage group was comparable to, and not significantly different from, that in the window cage group (96.6% and 93.8%, p > 0.99). The subsidence rate showed no significant difference between the window and non-window cage groups (15.6% and 3.4%, respectively; p = 0.262). The intra-cage osseointegration scores showed a significant difference between the groups (p = 0.007), with the non-window cage group having a higher proportion of cases with a score of 4 compared with the window cage group. The TBR sign was observed in 87.9% of patients who achieved interbody fusion, with a higher rate in the non-window cage group across the entire cohort although the difference was not significant (89.7% versus 78.1%, p = 0.385).CONCLUSIONSNon-window-type 3D-Ti cages showed equivalent clinical outcomes compared with window-type cages and comparable interbody fusion rates. These results suggest that the potential advantages of 3D-Ti cages could be optimized in the absence of a void for bone graft by providing a larger contact surface for osseointegration.LEVEL OF EVIDENCETherapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.","PeriodicalId":22625,"journal":{"name":"The Journal of Bone & Joint Surgery","volume":"34 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142174815","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"What's Important: Engaging Meaningfully with Sustainability Efforts as an Orthopaedic Surgeon.","authors":"Laura L Bellaire","doi":"10.2106/jbjs.24.00641","DOIUrl":"https://doi.org/10.2106/jbjs.24.00641","url":null,"abstract":"","PeriodicalId":22625,"journal":{"name":"The Journal of Bone & Joint Surgery","volume":"28 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142174814","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}