Journal of Bone and Joint Surgery, American Volume最新文献

Background: Unacceptable pain relief after hemiarthroplasty (HA) has limited its utilization for shoulder replacement. The material properties of pyrolytic carbon-graphite composites may result in less abrasion compared with metal bearing surfaces, theoretically decreasing glenoid-sided pain and erosion. This prospective, single-arm, multicenter study was performed to evaluate the short-term clinical outcomes and implant survivorship of pyrocarbon HA.

Methods: The enrollment of 157 patients occurred at 18 sites between December 2015 and April 2017 as part of an Investigational Device Exemption protocol. The Constant score, American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE) score, patient satisfaction, EuroQol-5 Dimensions (EQ-5D) score, and active range of motion were evaluated. A historical control cohort treated with cobalt-chromium HA was identified through a propensity score subclassification analysis. The pyrocarbon HA and cobalt-chromium HA cohorts were compared on the basis of a Composite Clinical Success (CCS) rate, defined as a ≥17-point change in the Constant score without revision or a device-related adverse event.

Results: Of the 157 patients enrolled, 144 had short-term follow-up (mean, 24.4 ± 1.2 months), 10 were lost to follow-up, and 3 underwent revision prior to 24 months due to pain or low-grade infection. The mean patient age was 52.4 ± 10.9 years (range, 19 to 73 years). There were significant improvements in all active range-of-motion and patient-reported outcomes. The outcomes of the pyrocarbon HA cohort (n = 157) were compared with those of the cobalt-chromium HA group (n = 169) eligible for a minimum 24-month follow-up, in which multiple imputation was employed to address missing data. The CCS was 82.7% for the pyrocarbon HA group and 66.8% for the cobalt-chromium HA group (p < 0.001).

Conclusions: Pyrocarbon HA demonstrated favorable results at a short-term follow-up and improved outcomes compared with the propensity score subclassification-derived cobalt-chromium HA cohort.

Level of evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Background: The Lenke classification for adolescent idiopathic scoliosis (AIS) has interobserver variability due to subjective clinical assessment. We developed and validated a fully automated deep learning system for precise Lenke classification using spinal radiographs.

Methods: This retrospective study included 650 individuals (mean age, 13.75 ± 2.23 years; 433 female, 217 male; 618 Han Chinese, 32 Tibetan), comprising 183 healthy controls and 467 patients with AIS (aged 10 to 18 years; 25° ≤ Cobb angle < 90°) with full-spine radiographs. A multistage deep learning system consisting of (1) Swin-Unet segmentation of vertebrae (C7-S1) for automated Cobb angle measurement, (2) DeepLabv3+ localization of lumbar pedicles (L1-L5) to determine modifiers via the centroid-to-CSVL (central sacral vertebral line) distance, and (3) a fusion module integrating features to curve types and lumbar (A/B/C) and sagittal thoracic (-/N/+) modifiers was designed to perform end-to-end Lenke classification automatically. Validation used an independent test set.

Results: The system achieved 95.6% overall accuracy in Lenke classification and had a macro-averaged F1 score of 0.862. Vertebral segmentation attained Dice coefficients of 0.917 (anteroposterior) and 0.942 (lateral). Cobb angle measurements showed excellent agreement with those of experts (intraclass correlation coefficient, 0.969 to 0.976 for thoracic or thoracolumbar/lumbar curves). Modifier assignment achieved F1 scores of 0.912 (lumbar A/B/C) and 0.928 (sagittal -/N/+), exceeding clinical acceptability thresholds.

Conclusions: The fully automated system was able to perform rapid, objective, interpretable, and clinically reliable classification of the Lenke type directly from radiographs, with performance comparable with that of expert assessment. It demonstrates potential for standardizing AIS surgical planning, reducing diagnostic variability, and improving surgical workflow efficiency.

Level of evidence: Diagnostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Background: There have been no long-term studies comparing the revision rates of a highly cross-linked polyethylene (HXLPE) bearing with those of a conventional polyethylene (CP) bearing among cruciate-retaining (CR) total knee arthroplasties (TKAs). The aim of the current long-term study was to compare CR TKAs with HXLPE and CP bearings in terms of clinical, radiographic, and computed tomographic (CT) scan results; prevalence of osteolysis; revision rate; and implant survivorship.

Methods: This study enrolled a consecutive series of 410 Korean patients (mean age, 62.6 ± 8 years) who underwent simultaneous bilateral TKAs during the same anesthetic session. This study included 164 men and 246 women. Each patient underwent a posterior CR high-flexion TKA (NexGen CR-Flex TKA; Zimmer Biomet) with an HXLPE bearing on 1 side and a NexGen CR-Flex TKA with a CP bearing on the opposite side. The mean follow-up period was 17.5 years (range, 15 to 19 years).

Results: At the latest follow-up, there were no significant differences between the HXLPE and CP groups with regard to the Knee Society score (94 compared with 93 points), Western Ontario and McMaster Universities Osteoarthritis Index (19.2 points for both groups), range of motion (125° compared with 126°), radiographic and CT results, or revision rate (2.0% compared with 2.2%). No knee showed osteolysis in either group. The estimated survival rate at 17.5 years, using revision or aseptic loosening as the end point, was 98.0% (95% confidence interval, 92% to 100%) for the group with the CR-Flex TKA with an HXLPE bearing and 97.8% (95% confidence interval, 92% to 100%) for the group with the CR-Flex TKA with a CP bearing.

Conclusions: The findings of this long-term study (minimum follow-up of 15 years) indicate that CR-Flex TKAs with HXLPE and CP bearings both yielded excellent clinical outcomes and implant survivorship. However, no significant clinical advantage was observed for HXLPE over CP bearings in this patient population.

Level of evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Background: This study evaluated the progression of humeral head medialization in patients who underwent pyrocarbon hemiarthroplasty (PyC-HA). The authors hypothesized that glenoid erosion would not dramatically progress between the short-term and final imaging evaluations, and that there would be excellent clinical outcomes at ≥5-year follow-up.

Methods: Patients who underwent PyC-HA with ≥60 months of follow-up were included in this prospective study. Relevant data included preoperative demographic characteristics, Walch glenoid classification, changes in clinical outcomes, and revision-free and failure-free survival rates. An investigator, who was blinded to patient outcomes, assessed the glenoid morphology, changes in medialization, joint space, acromiohumeral distance (AHD), critical shoulder and β angles, and posterior subluxation in decentered glenoids at the 2-year and final follow-up visits.

Results: Forty-five patients with a mean age of 52 years and a mean follow-up of 73 months met the inclusion criteria. Significant improvements were observed across all outcome measures. The 7-year revision-free survival rate was 95.7%. Posterior subluxation in decentered shoulders decreased from 27.1% preoperatively to 19.8% postoperatively (p = 0.008). The mean medialization of the humeral head was 2.9 ± 2.8 mm at the 2-year follow-up and increased to 4.0 ± 3.3 mm at the time of the final follow-up (p = 0.096). A >2-mm decrease in AHD from early postoperative to final imaging was observed in 82.2% of patients (p < 0.001). All other radiographic changes were not significant.

Conclusions: PyC-HA is a reliable procedure for treating glenohumeral joint disease, demonstrating excellent clinical outcomes and stabilized glenoid morphology in the majority of patients between the 2-year and intermediate-term follow-up.

Level of evidence: Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.

Background: Novel osteoconductive and osteoinductive therapies for posterior-based lumbar interbody fusion surgery are needed. Bezeotermin alfa (recombinant human bone morphogenetic protein [rhBMP]-6, previously referred to as AGA111) is a potential potent stimulator of bone regeneration. This prospective, multicenter, randomized, double-blinded, placebo-controlled Phase-2 trial evaluated the safety and preliminary efficacy of bezeotermin carried by autologous blood coagulum (ABC) in patients undergoing lumbar interbody fusion surgery between L3 and S1 for degenerative disc disease.

Methods: Adult patients scheduled for single-level elective lumbar interbody fusion surgery across 6 clinical trial sites in the People's Republic of China were randomized 1:1:1 to placebo, 0.25 mg bezeotermin, or 0.5 mg bezeotermin and followed for 12 months. The primary end point was the incidence of adverse events (AEs). Secondary end points included anti-rhBMP-6 antibodies, the success rate of radiographic fusion, changes in the Oswestry Disability Index (ODI) score, changes in the pain score on a visual analogue scale (VAS), and serum drug concentrations.

Results: Sixty-three patients with a mean age of 59.2 years (52% female, 98.4% Han) were enrolled in the study. Twenty-one, 20, and 22 of the patients were randomized to placebo, 0.25 mg bezeotermin, and 0.5 mg bezeotermin, respectively. All patients reported at least 1 AE during the study, but most AEs were mild to moderate in severity. No drug-related serious AEs were reported in the bezeotermin groups. There was a trend toward a higher rate of successful radiographic fusion and greater improvement of the ODI and VAS scores in the bezeotermin groups than in the placebo group from month 3 to month 12.

Conclusions: This prospective, randomized, double-blinded, placebo-controlled trial demonstrated that bezeotermin/ABC was safe and well tolerated during posterior-based single-level lumbar interbody fusion. The preliminary efficacy of bezeotermin in accelerating spinal fusion and improving clinical outcomes supports its further clinical development.

Level of evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

➢ Medical malpractice litigation in orthopaedic surgery remains a major challenge, as the field consistently ranks among the most frequently litigated specialties. Malpractice claims in orthopaedics often involve surgical errors, misdiagnoses, delayed treatment, and inadequate postoperative care, with substantial financial and emotional consequences for health-care providers.➢ Malpractice risk varies by orthopaedic subspecialty, with adult reconstruction and spine surgeons facing the highest litigation rates, often due to nerve injuries, delayed or missed diagnoses, or postoperative complications. Although defense verdicts are the most common outcome, substantial settlements and plaintiff verdicts occur in cases involving irreversible damages, inadequate informed consent, or technical errors.➢ Proactive risk management and legal preparedness can help to mitigate liability and protect physicians. Preventative strategies include clear, supportive communication to build patient trust, comprehensive documentation ensuring adherence to evidence-based guidelines, and diagnostic accuracy through use of objective tools.

Background: Alcohol negatively affects bone health and fracture repair, yet its effects on implant osseointegration remain poorly understood. This in vivo study utilized a previously developed murine model to evaluate implant osseointegration before and after continuous ethanol consumption.

Methods: Adult mice were given regular drinking water (control group) or 10% to 15% ethanol in their drinking water for 3 months before undergoing surgical implantation of a load-bearing, porous titanium implant in the proximal tibia. Ethanol consumption was continued until euthanasia at 4 weeks post-implantation (ethanol group) or stopped immediately post-implantation (abstinence group) to mimic postoperative ethanol cessation. Osseointegration was assessed using micro-computed tomography (micro-CT), biomechanical pullout testing, and histological analysis.

Results: Mice with continuous ethanol consumption exhibited significantly reduced peri-implant bone formation, as measured with histology and micro-CT, compared with controls. Biomechanical testing demonstrated a weaker bone-implant interface in the ethanol group compared with controls. In contrast, postoperative abstinence restored the peri-implant bone formation and bone-implant interface strength to levels similar to those in the control group.

Conclusions: Ethanol consumption compromised implant osseointegration in mice, while postoperative abstinence promoted the recovery of peri-implant bone formation and interface strength.

Clinical relevance: Future clinical studies are needed to assess the impact of preoperative and postoperative abstinence of ethanol on osseointegration of orthopaedic implants.