Dataset Information

Effect of Denosumab on Femoral Periprosthetic BMD and Early Femoral Stem Subsidence in Postmenopausal Women Undergoing Cementless Total Hip Arthroplasty.

ABSTRACT: Antiresorptive denosumab is known to improve the quality and strength of cortical bone in the proximal femurs of osteoporotic women, but its efficacy in preventing periprosthetic bone loss and reducing femoral stem migration has not been studied in women undergoing cementless total hip arthroplasty. We conducted a single-center, randomized, double-blinded, placebo-controlled trial of 65 postmenopausal women with primary hip osteoarthritis and Dorr type A or B proximal femur anatomy. The patients randomly received subcutaneous injections of denosumab 60?mg or placebo once every 6 months for 12 months, starting 1 month before surgery. The primary endpoint was the change in bone mineral density (BMD) of the proximal femur (Gruen zone 7) at week 48, and the secondary endpoint was stem subsidence measured by radiostereometric analysis (RSA) at week 48. Exploratory endpoints included changes in BMDs of the contralateral hip, lumbar spine and distal radius, serum levels of bone turnover markers, walking speed, walking activity, patient-reported outcome measures, and radiographic assessment of stem osseointegration. The participants underwent vertebral-fracture assessment in an extension safety study at 3 years. Denosumab significantly decreased bone loss in the medial femoral neck (zone 7) and increased periprosthetic BMD in the greater trochanteric region (zone 1) and lesser trochanteric region (zone 6). Denosumab did not reduce temporary femoral stem migration. The migration occurred mainly during the settling period (0 to 12 weeks) after implantation of the prosthesis. All of the stems osseointegrated, as evaluated by RSA and radiographs. There were no intergroup differences in functional recovery. Discontinuation of denosumab did not lead to any adverse events. In conclusion, denosumab increased periprosthetic BMD in the clinically relevant regions of the proximal femur, but the treatment response was not associated with any reduction of initial stem migration. © 2019 The Authors. JBMR Plus published by Wiley Periodicals, Inc. on behalf of the American Society for Bone and Mineral Research.

SUBMITTER: Aro HT

PROVIDER: S-EPMC6820573 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Effect of Denosumab on Femoral Periprosthetic BMD and Early Femoral Stem Subsidence in Postmenopausal Women Undergoing Cementless Total Hip Arthroplasty.

Aro Hannu T HT Nazari-Farsani Sanaz S Vuopio Mia M Löyttyniemi Eliisa E Mattila Kimmo K

JBMR plus 20190814 10

Antiresorptive denosumab is known to improve the quality and strength of cortical bone in the proximal femurs of osteoporotic women, but its efficacy in preventing periprosthetic bone loss and reducing femoral stem migration has not been studied in women undergoing cementless total hip arthroplasty. We conducted a single-center, randomized, double-blinded, placebo-controlled trial of 65 postmenopausal women with primary hip osteoarthritis and Dorr type A or B proximal femur anatomy. The patients ...[more]

PMID: 31687650

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Project description:Mortality related to femoral neck fractures remains a challenging health issue, with a high mortality rate at 1 year of follow-up. Three modifiable factors appear to be under control of the surgeon: the choice of the implant, the use of cement and the timing before surgery. The aim of this research project was to study the impact on mortality each of these risk factors play during the management of femoral neck fractures. A large retrospective epidemiological study was performed using a national database of the public healthcare system. The inclusion criteria were patients who underwent joint replacement surgery after femoral neck fracture during the years 2015 to 2017. All data points were available for at least 2 years after the fracture. The primary outcome was mortality within 2 years following the surgery. We evaluated the association between mortality and the type of the implant hemiarthroplasty (HA) versus total hip arthroplasty (THA), cemented versus non cemented femoral stem as well as the timing from fracture to surgical procedure. A multivariate analysis was performed including age, gender, comorbidities/autonomy scores, social category, and obesity. We identified 96,184 patients who matched the inclusion criteria between 2015 and 2017. 64,106 (66%) patients underwent HA and 32,078 (33.4%) underwent THA. After multivariate analysis including age and comorbidities, patients who underwent surgery after 72 h intra-hospital had a higher risk of mortality: Hazard Ratio (HR) = 1.119 (1.056-1.185) p = 0.0001 compared to the group who underwent surgery within 24 h. THA was found to be a protective factor HR = 0.762 (0.731-0.795) p < 0.0001. The use of cement was correlated with higher mortality rate: HR = 1.107 (1.067-1.149) p < 0.0001. Three key points are highlighted by our study in the reduction of mortality related to femoral neck fracture: the use of hemiarthroplasty a surgery performed after 48 h and the use of cement for femoral stem fixation adversely affect mortality risk.

Project description:The present study aimed to investigate the prevalence and clinical consequences of occult intra-operative periprosthetic femoral fractures in total hip arthroplasty (THA). Between 2012 and 2017, a total of 113 primary THAs were enrolled. The mean age of the patients was 66.4 ± 7.6 years. We assessed occult intra-operative periprosthetic femoral fractures with the use of computed tomography (CT) and risk factors, including age, sex, body mass index, diagnosis, stem size, and radiographic parameters of proximal femoral geometry were analyzed. We also assessed the differences in thigh pain and stem subsidence and alignment between the patients with and without occult periprosthetic femoral fracture. Occult intra-operative periprosthetic femoral fractures were found in 13 of 113 hips (11.5%). In 9/13 (69.2%) of occult fractures, fracture lines were started from the region below the tip of the lesser trochanter. Six periprosthetic femoral fractures (5.3%) were found during the operation. Out of the five hips that had detected femoral fractures around the lesser trochanter intra-operatively, four hips (80%) showed concurrent occult fractures on different levels. The female sex (P = .01) and canal filling ratio at 7 cm below the tip of the lesser trochanter (P = .01) were significantly different between the patients with and without occult periprosthetic femoral fracture. The sex was significantly associated with an increased risk in predicting an occult intra-operative periprosthetic femoral fracture (odds ratio of male, 0.25 compared with the female; 95% CI, 0.08-0.85; p = .02). There was a significant difference in the incidence of thigh pain between occult fracture group and non-occult fracture group (P < .05). There were no significant differences in stem subsidence and alignment between the patients with and without occult periprosthetic femoral fracture. All 13 cases of occult intra-operative periprosthetic femoral fractures were healed at the final follow-up. Occult periprosthetic femoral fractures are common during a long, trapezoidal, double-tapered cementless femoral stem fixation in primary THA, that CT scans are helpful to identify them, and that these fractures do not adversely affect the implant's survival if a rigid fixation of the implants has been achieved.

Dataset Information

Effect of Denosumab on Femoral Periprosthetic BMD and Early Femoral Stem Subsidence in Postmenopausal Women Undergoing Cementless Total Hip Arthroplasty.

Publications

Effect of Denosumab on Femoral Periprosthetic BMD and Early Femoral Stem Subsidence in Postmenopausal Women Undergoing Cementless Total Hip Arthroplasty.

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