Minimally invasive clamp-assisted reduction and long InterTAN nail fixation for Seinsheimer type V subtrochanteric fractures: a case series describing the technique and results.

BACKGROUND: Surgical treatment of Seinsheimer type V subtrochanteric fractures is extremely challenging due to the difficulty of obtaining and maintaining anatomic reduction and effective fixation. The purpose of this study was to describe a surgical technique for minimally invasive clamp-assisted reduction and long InterTAN nail fixation to manage Seinsheimer type V subtrochanteric fractures and report the clinical and radiological results. METHODS: A retrospective study was conducted on patients with Seinsheimer type V subtrochanteric fractures between March 2015 and June 2021. A total of 30 patients treated via minimally invasive clamp-assisted reduction, long InterTAN nail fixation and selective augmentation with a cerclage cable were included. The following data were collected and evaluated: patient demographics, operative time, blood loss, reduction quality, tip apex distance (TAD), time to bone union, Harris hip score (HHS), visual analog score (VAS), and complications. RESULTS: The mean age of the 30 patients was 64.8 years (range: 36-90 years). The mean operative time was 102.2 min (range: 70-150 min). The mean loss of blood was 318.3 ml (range: 150-600 ml). The reduction quality involved 27 cases of anatomic reduction and 3 cases of satisfactory reduction. The mean TAD was 16.3 mm (range: 8-24 mm). The mean follow-up time was 18.9 months (range: 12-48 months). The mean fracture healing time was 4.5 months (range: 3-8 months). The mean Harris score was 88.2 (range: 71-100), and the VAS score was 0.7 (range: 0-3). Delayed union of the subtrochanteric fracture site occurred in two patients. The limb length discrepancy, which was determined in 3 patients, was < 10 mm. There were no significant complications. CONCLUSION: Our results indicate that minimally invasive clamp-assisted reduction with long InterTAN nail fixation is encouraging for Seinsheimer Type V subtrochanteric fractures, resulting in excellent reduction and fixation. Additionally, this reduction technique is simple, reliable, and effective in reducing and maintaining subtrochanteric fractures, particularly when intertrochanteric fractures are irreducible.

Denosumab biosimilar (LY06006) in Chinese postmenopausal osteoporotic women: A randomized, double-blind, placebo-controlled, multicenter phase III study.

Objectives: This study assessed the efficacy, safety, pharmacokinetics (PK), and immunogenicity profiles of a denosumab biosimilar (LY06006) in Chinese postmenopausal osteoporotic women with a high risk of fracture. Methods: In this multicenter, randomized, double-blind, placebo-controlled, phase 3 trial, 448 postmenopausal women aged 50-85 years with osteoporosis were enrolled at 49 centers in China and were randomly assigned (3:1) to receive 60 â€‹mg of the denosumab biosimilar (LY06006) or placebo subcutaneously every 6 months for 1 year. Lumbar spine bone mineral density (BMD) change was the primary endpoint. Results: Of the 448 randomized patients, 409 (LY06006, n â€‹= â€‹311; placebo, n â€‹= â€‹98) completed the study. All 448 (100.0%) subjects were included in the intent-to-treat (ITT) trial, 427 (95.3%) were included in the full analysis set (FAS), 408 (91.1%) were included in the per protocol set (PPS), 446 (99.6%) were included in the safety set (SS), and 336 (75.0%) were included in the pharmacokinetics concentration set (PKCs). For the primary endpoint, a 4.71% (95% CI, 3.81%, 5.60%) treatment difference in percent change in lumbar spine BMD from baseline to month 12 was observed in the LY06006 group compared with the placebo group (P â€‹< â€‹0.0001). For the secondary endpoints, LY06006 was associated with increased lumbar spine BMD levels measured at month 6, BMD levels at the femoral neck, total hip, and trochanter measured at months 6 and 12 and reduced serum C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 â€‹N-peptide (P1NP) levels at months 1, 6, and 12. Safety analysis was based on the safety analysis set (SS), and 264 (78.6%) subjects in the LY06006 group and 83 (75.5%) in the placebo group experienced adverse events (AEs). Most events were mild or moderate and not related to the study drugs. Conclusion: In postmenopausal women with a high risk of fracture, LY06006 increased the BMD and decreased bone resorption; thus, LY06006 might be an effective treatment for osteoporosis. LY06006 was generally safe and well tolerated without unexpected adverse reactions, similar to the reference drug Prolia®. The characteristics of effectiveness and safety were similar to those reported in previous studies. The translational potential of this article: In this multi-center, randomized, double-blind, placebo-controlled phase 3 study, LY06006 showed substantially efficacy to increase BMD and well tolerance without unexpected adverse reactions, which is comparable to the reference drug Prolia ®. The presented results are encouraging and can offer some valuable evidence for the clinical practice.

Inverted distal clavicle anatomic locking plate for displaced medial clavicle fracture.

Fractures of the medial clavicle are rare injuries. Recently, open reduction and internal fixation has been recommended for displaced medial clavicle fractures in order to prevent non-union and dysfunction. Because of the rarity of this injury, the optimal fixation device has not yet been established. In this report, we describe a case of a 40-year-old male patient who sustained a significantly displaced medial clavicle fracture treated by open reduction and internal fixation using an inverted distal clavicle anatomic locking plate. At the 12 months follow-up, the patient recovered well, had returned to pre-injury job, and was quite satisfied with the outcome. Internal fixation of medial clavicle fracture using an inverted distal clavicle anatomic locking plate of the ipsilateral side appears to be a good treatment option.