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

Abstract: In recent years, the medical field has recognized the pivotal role of diversity, equity, and inclusion (DEI) in enhancing patient care and addressing health-care disparities. Orthopaedic surgery has embraced these principles to create a more inclusive and representative workforce. A DEI symposium that was sponsored by the American Orthopaedic Association convened orthopaedic surgeons, researchers, educators, and stakeholders to discuss challenges and strategies for implementing DEI initiatives. The symposium emphasized the importance of equity, and fostered conversations on creating equal opportunities and resources. Speakers covered key topics, including establishing DEI divisions, metrics for success, DEI leadership, and available resources, and promoted excellence and innovation in orthopaedic surgery through a more diverse and inclusive approach.

Background: A prospective cohort study was conducted to assess the predictors of failure of nonoperative treatment, defined as the patient undergoing surgery for symptomatic, atraumatic full-thickness rotator cuff tears. We present the 10-year follow-up data of this population to determine if predictors for surgery change over time, and secondarily we report the outcomes of the cohort.

Methods: At the time of enrollment, demographic, symptom, rotator cuff anatomy, and patient-reported outcome data were collected in patients with symptomatic, atraumatic full-thickness rotator cuff tears. Patients underwent a standard physical therapy protocol for 6 to 12 weeks. Patient data were then collected at 1, 2, 5, 7, and 10 years. Failure of nonoperative treatment was defined as the patient electing to undergo surgery.

Results: Of the 452 patients in the original cohort, 20 patients (5%) withdrew from the study, 37 (9%) died before 10 years, and 40 (9%) were otherwise lost to follow-up. A total of 115 patients (27.0%) underwent a surgical procedure at some point during the 10-year follow-up period. Of these patients, 56.5% underwent surgery within 6 months of enrollment and 43.5%, between 6 months and 10 years. Low patient expectations regarding the efficacy of physical therapy were found to be a predictor of early surgery. Workers' Compensation status and activity level were more important predictors of later surgery. Patient-reported outcome measures all improved following physical therapy. For patients who did not undergo a surgical procedure, patient-reported outcome measures did not decline over the 10-year follow-up period.

Conclusions: Low patient expectations regarding the efficacy of physical therapy were found to be a predictor of early surgery, whereas Workers' Compensation status and activity level were predictors of later surgery. Physical therapy was successful in >70% of patients with symptomatic, atraumatic full-thickness rotator cuff tears at 10 years. Outcome measures improved with physical therapy and did not decline over the 10-year follow-up period.

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

➤ Posterior tibial slope (PTS) of ≥12° represents an important risk factor for both anterior cruciate ligament (ACL) injury and ACL reconstruction failure.➤ PTS measurements can significantly differ on the basis of the imaging modality and the measurement technique used. PTS should be measured on strictly lateral radiographs, with a recommended proximal tibial length of 15 cm in the image. The PTS measurement can be made by placing 2 circles to define the proximal tibial axis, 1 just below the tibial tubercle and another 10 cm below it. PTS measurements are underestimated when made on magnetic resonance imaging and computed tomography.➤ Slope-reducing osteotomies can be performed using a (1) supratuberosity, (2) tubercle-reflecting transtuberosity, or (3) infratuberosity method. The correction target remains a topic of debate. Although it is controversial, some authors recommend overcorrecting the tibial slope slightly to a range of 4° to 6°. For instance, if the initial slope is 12°, a correction of 6° to 8° should be performed, given the target tibial slope of 4° to 6°.➤ Clinical outcomes following slope-reducing osteotomies have been favorable. However, potential complications, limited data with regard to the impact of slope-reducing osteotomies on osteoarthritis, and uncertainty with regard to the effects on the patellofemoral joint are notable concerns.➤ Patients with complex deformities may need biplanar osteotomies to comprehensively address the condition.

Background: Despite a tremendous increase in the number of orthopaedic devices authorized by the U.S. Food and Drug Administration (FDA), novel devices designed specifically for the pediatric population remain sparse. Surgeons frequently repurpose adult implants for "off-label" use in pediatric patients, with both legal and technical ramifications. This study seeks to objectively quantify and characterize the nature of pediatric device innovation over time.

Methods: The FDA employs 4 pathways for assessing safety and effectiveness of novel devices prior to authorization. Perceived device risk and novelty determine the pathway. Orthopaedic devices were identified from the FDA's online database. All devices approved since inception via the Humanitarian Device Exemption, Pre-Market Approval, and De Novo regulatory pathways were included and grouped as "highly innovative." Because of their number and the rapidity of their development, the evaluation of 510(k) devices was limited to those cleared from January 1, 2018, to December 31, 2022. Such 510(k) devices make up ∼97% of devices and by definition are less risky and less novel. Approval statements were assessed for pediatric indications within the approved labeling. As a secondary analysis, the impact of company size on developing a product with a pediatric indication was analyzed.

Results: Of the 1,925 devices cleared via the 510(k) pathway, 9 (0.5%) were designed exclusively for pediatrics and 160 (8.3%) included pediatric indications. Five of the 9 pediatrics-only devices were for spine and 4 were for trauma indications. Of the 97 highly innovative devices, only 2 (2%) were exclusively pediatric and another 2 (2%) included pediatric indications. The 2 pediatrics-only devices were for the spine. Large and medium-sized companies were 1.9 times and 1.6 times more likely to bring to market a device with pediatric indications than a small company, respectively.

Conclusions: Innovation for pediatric orthopaedic devices lags substantially behind that for adult orthopaedic devices. These findings are consistent with clinical experience and the common practice of modifying adult implants for "off-label" use in pediatric patients. Despite long-standing efforts to stimulate innovation for this vulnerable population, our results suggest little progress.

Background: Unicompartmental knee replacement (UKR) is an effective treatment for end-stage medial compartment osteoarthritis, but there can be problems with fixation. The cementless UKR was introduced to address this issue. It is unknown how its functional outcomes compare with those of the cemented version on a national scale. We performed a matched comparison of the clinical and functional outcomes of cementless and cemented UKRs.

Methods: Using the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR), 14,764 Oxford UKRs with linked data regarding patient-reported outcomes were identified. A total of 6,906 UKRs (3,453 cemented and 3,453 cementless) were propensity score matched on the basis of patient, surgical, and implant factors.

Results: The 10-year cumulative implant survival rate was 93.0% (95% confidence interval [CI], 90.0% to 95.1%) for cementless UKRs and 91.3% (95% CI, 89.0% to 93.0%) for cemented UKRs. The cementless UKR group had a significantly lower revision risk (hazard ratio [HR], 0.74; p = 0.02). Subgroup analyses showed a stronger effect size (HR, 0.66) among UKRs performed by high-caseload surgeons (i.e., surgeons performing ≥30 UKRs/year). In the overall cohort, the postoperative Oxford Knee Score (OKS) in the cementless group (mean and standard deviation, 39.1 ± 8.7) was significantly higher (p = 0.001) than that in the cemented group (38.5 ± 8.6). The cementless group gained a mean of 17.6 ± 9.3 points in the OKS postoperatively and the cemented group gained 16.5 ± 9.6 points, with a difference of 1.1 points between the groups (p < 0.001). The difference in OKS points gained postoperatively was highest among UKRs performed by high-caseload surgeons, with the cementless group gaining 1.8 points more (p < 0.001) than the cemented group.

Conclusions: The cementless UKR demonstrated better 10-year implant survival and postoperative functional outcomes than the cemented UKR. The difference was largest among UKRs performed by high-caseload surgeons, with the cementless fixation group having an HR for revision of 0.66 and an approximately 2-point greater improvement in the OKS compared with the cemented fixation group.

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

Update: This article was updated on September 4, 2024 because of a previous error, which was discovered after the preliminary version of the article was posted online. In the Note listing the members of the Wrist and Elbow Research Group of Canada, the text that had read "Thomas T. Goetz, MD, FRCSC" now reads "Thomas J. Goetz, MD, FRCSC".

Background: The primary goal after open reduction and internal fixation of an established scaphoid nonunion is to achieve union. Low-intensity pulsed ultrasound (LIPUS) has been reported to increase the rate of union and to decrease the time to union for multiple fractures and nonunions in clinical and animal models. The evidence for LIPUS in the treatment of scaphoid nonunion, however, is sparse. The aim of this study was to assess whether active LIPUS (relative to sham LIPUS) accelerates the time to union following surgery for scaphoid nonunion.

Methods: Adults with a scaphoid nonunion indicated for surgery were recruited for a multicenter, prospective, double-blinded randomized controlled trial. After surgery, patients self-administered activated or sham LIPUS units beginning at their first postoperative visit. The primary outcome was the time to union on serial computed tomography (CT) scans starting 6 to 8 weeks postoperatively. Secondary outcomes included patient-reported outcome measures, range of motion, and grip strength.

Results: A total of 142 subjects completed the study (69 in the active LIPUS group and 73 in the sham group). The average age was 27 years, and the cohort was 88% male. There was no difference in time to union (p = 0.854; hazard ratio, 0.965; 95% confidence interval, 0.663 to 1.405). Likewise, there were no differences between the active LIPUS and sham groups with respect to any of the secondary outcomes, except for wrist flexion at baseline (p = 0.008) and at final follow-up (p = 0.043).

Conclusions: Treatment with LIPUS had no effect on reducing time to union in patients who underwent surgical fixation of established scaphoid nonunions.

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