An Observational Prospective Clinical Study for the Evaluation of a Collagen-Hydroxyapatite Composite Scaffold in Hip Revision Surgery.

One of the greatest challenges of hip revision surgery is the need to restore extensive bone loss by creating a stable reconstruction with long-term durability. The present observational, investigator-initiated prospective study was carried out to evaluate the clinical and radiological results of the use of a commercial biomimetic collagen-hydroxyapatite composite biomaterial (RegenOss) applied in hip revision surgery. Thirty-three patients who underwent hip revision were included in this study, and 29 received up to 2 years of follow-up. The acetabulum was reconstructed using an uncemented hemispherical shell both with or without an iliac fixation stem. Functional recovery was assessed according to the Harris Hip Score (HHS) at the pre-hospitalisation check-up, and at 6-, 12-, and 24-month follow-ups. Radiological evaluation consisting of X-ray analyses (6, 12, and 24 month follow-ups) and CT scan exams (within 10 weeks post-surgery and at 12-month follow-up) were performed to evaluate the reduction in bone defect and new bone regeneration. All the patients reported a complete recovery and a considerable improvement in functional outcome assessed by the HHS, which was significantly higher at all the follow-ups than at pre-hospitalisation. Moreover, radiological assessments revealed good scaffold integration. Overall, collected data suggest that RegenOss is a valid and safe alternative to restoring acetabular bone loss in revision hip arthroplasty.

Early mortality in hip fracture patients admitted during first wave of the COVID-19 pandemic in Northern Italy: a multicentre study.

BACKGROUND: Treatment of hip fractures during the coronavirus disease 2019 (COVID-19) pandemic has posed unique challenges for the management of COVID-19-infected patients and the maintenance of standards of care. The primary endpoint of this study is to compare the mortality rate at 1 month after surgery in symptomatic COVID-positive patients with that of asymptomatic patients. A secondary endpoint of the study is to evaluate, in the two groups of patients, mortality at 1 month on the basis of type of fracture and type of surgical treatment. MATERIALS AND METHODS: For this retrospective multicentre study, we reviewed the medical records of patients hospitalised for proximal femur fracture at 14 hospitals in Northern Italy. Two groups were formed: COVID-19-positive patients (C+ group) presented symptoms, had a positive swab for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and received treatment for COVID-19; COVID-19-negative patients (C- group) were asymptomatic and tested negative for SARS-CoV-2. The two groups were compared for differences in time to surgery, survival rate and complications rate. The follow-up period was 1 month. RESULTS: Of the 1390 patients admitted for acute care for any reason, 477 had a proximal femur fracture; 53 were C+ but only 12/53 were diagnosed as such at admission. The mean age was > 80 years, and the mean American Society of Anesthesiologists (ASA) score was 3 in both groups. There was no substantial difference in time to surgery (on average, 2.3 days for the C+ group and 2.8 for the C- group). As expected, a higher mortality rate was recorded for the C+ group but not associated with the type of hip fracture or treatment. No correlation was found between early treatment (< 48 h to surgery) and better outcome in the C+ group. CONCLUSIONS: Hip fracture in COVID-19-positive patients accounted for 11% of the total. On average, the time to surgery was > 48 h, which reflects the difficulty of maintaining normal workflow during a medical emergency such as the present pandemic and notwithstanding the suspension of non-urgent procedures. Hip fracture was associated with a higher 30-day mortality rate in COVID-19-positive patients than in COVID-19-negative patients. This fact should be considered when communicating with patients and/or their family. Our data suggest no substantial difference in hip fracture management between patients with or without COVID-19 infection. In this sample, the COVID-19-positive patients were generally asymptomatic at admission; therefore, routine screening is recommended. LEVEL OF EVIDENCE: Therapeutic study, level 4.

A new computerized tomography classification to evaluate response to Denosumab in giant cell tumors in the extremities.

OBJECTIVES: The aim of this study was to describe the cohort of patients who have been treated with Denosumab as neoadjuvant therapy prior to surgery for aggressive giant cell tumor of bone in the extremities, to evaluate the radiological responses to Denosumab comparing Choi criteria and a newly described computerized tomography (CT) classification, and to evaluate the risk of local recurrence after intralesional curettage or radical excision. METHODS: We retrospectively evaluated 36 patients (20 females and 16 males; mean age at diagnosis 36 years (range, 18-64)) treated with neoadjuvant Denosumab therapy prior to surgery for aggressive giant cell tumor of bone in the extremities. The radiological responses to Denosumab treatment were analyzed on the preoperative images after the neoadjuvant course with the Choi criteria and with a newly proposed classification based on CT. All these images were independently reviewed by two of the researchers. Surgical intervention methods were noted and local recurrence rates were evaluated. The correlation between radiological response amount and local recurrence were analyzed for both Choi criteria and the new CT classification. RESULTS: Denosumab was administered for a mean of 21 weeks (range 7-133). Five patients also had a short postoperative course. According to Choi criteria there was a radiological response in 32 patients (89%), while the new CT classification identified responses in all the 36 patients (100%). The identification of changes after 7 weeks of treatment was higher using the CT classification compared to Choi criteria (p = 0.043 vs p = 0.462). The surgical interventions after Denosumab comprised curettage in 29 patients (74%) and resection in 7 (26%). Local recurrence was higher in patients managed with intralesional curettage than in those treated with en bloc resection (55.1% vs 0%, p < 0.001). At last follow up 19 patients (53%) required en bloc resections. Good responders to Denosumab (type 2C) had lower risk of local recurrence (p = 0.047) after either resection or curettage. CONCLUSION: The new CT classification evaluated more accurately the response to Denosumab. Our experience suggests that the requirement for radical bone resection remains high despite the use of Denosumab. LEVEL OF EVIDENCE: Level IV, Therapeutic Study.