Contributing factors to the initial femoral stem migration in cementless total hip arthroplasty of postmenopausal women

Nazari-Farsani, Sanaz; Vuopio, Mia; Löyttyniemi, Eliisa; Aro, Hannu T.

doi:10.1016/j.jbiomech.2021.110262

Cited by 13 publications

(12 citation statements)

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“…The detailed trial protocol and the results were reported previously. ( 8 ) Further analyses ( 11 , 12 , 13 ) examined the diagnostic accuracy of dual‐energy X‐ray absorptiometry (DXA), quantitative computed tomography (QCT), and pulse‐echo ultrasonometry in predicting stem migration and evaluating the clinical significance of RSA‐measured stem subsidence (≥2 mm). The trial was approved by the Ethics Committee of the Hospital District of South‐West Finland (decisions 105/2012 and 484/2017) and the Finnish Medicines Agency (decision 183/06.00.00/2012, EudraCT 2011–000628‐14).…”

Section: Methodsmentioning

confidence: 99%

“…However, influential outliers were identified in further analyses of contributing factors for stem migration. ( 11 , 12 , 13 ) A concern arose over the possibility that the outliers might hide a more subtle treatment effect of denosumab. The selected statistical method, linear mixed modeling (LMM), is also susceptible to outlier‐introduced bias.…”

Section: Introductionmentioning

confidence: 99%

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Denosumab in Cementless Total Hip Arthroplasty: Multivariate Reanalysis of 3D Femoral Stem Migration and the Influence on Outliers

2021

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In cementless total hip arthroplasty, adequate implant stability is necessary for the success of osseointegration and rapid clinical recovery. Postoperative femoral stem migration, measured by radiostereometric analysis (RSA), defines the initial stability achieved during surgical implantation. In a recent trial of 65 postmenopausal women randomized 1:1 denosumab:placebo, denosumab failed to reduce the initial migration of a cementless femoral stem despite the successful prevention of periprosthetic bone loss. The trial applied the current RSA standard, which examined stem migration on an axis‐by‐axis basis and did not consider more complex three‐dimensional (3D) migration. Therefore, we performed a reanalysis of the trial data using a multivariate hierarchical linear mixed model (LMM). As an additional limitation, the data included influential outliers. Women with normal bone mineral density exhibited significantly (p = 0.036) less stem subsidence compared with osteopenic and osteoporotic women. Denosumab significantly decreased the variance of stem migration in osteopenic and osteoporotic women. The mean magnitude of 3D stem migration did not differ between denosumab‐treated and placebo‐treated women (p = 0.820). After application of a common statistical definition for RSA outlier identification, there were eight (12%) outliers, six in the placebo group and two in the denosumab group (p = 0.149). After exclusion of the outliers, the repeated LMM analysis demonstrated a trending difference in 3D stem migration (p = 0.086), with a significant difference of z‐axis rotation (valgus‐varus tilt) of the femoral stem (p = 0.029). The observed effect size was small and without clinically important differences in postoperative recovery. Based on a Monte Carlo simulation with random‐generated 3D migration data, multivariate LMM showed greater statistical power than univariate analyses. The application of hierarchical LMM facilitated the analysis of implant migration as a factual 3D event. The observed trend in the lower number of RSA outliers in denosumab‐treated subjects warrants powered large‐scale trials. © 2021 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Denosumab in Cementless Total Hip Arthroplasty: Multivariate Reanalysis of 3D Femoral Stem Migration and the Influence on Outliers

2021

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“…Even in women, physical activity seems to dictate the direction of stem rotation. Femoral stems are affected by high torsional moments during daily activities (Bergmann et al 2001) and postoperative walking activity, aside from total hip BMD, is associated with stem rotation in postmenopausal women (Nazari-Farsani et al 2021). Early walking activity creates the typical pattern of slight internal stem rotation, while stems do not rotate in women with low walking activity.…”

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confidence: 99%

“…A parallel-sided femoral stem showed subsidence (mean 1.8 mm) even in postmenopausal women with normal hip BMD and Dorr A/B femur anatomy (Nazari-Farsani et al. 2021 ). Analyses with quantitative computed tomography (QCT) revealed that the stem subsidence occurred in women with high bone turnover and decreased volumetric BMD of the intertrochanteric region (Aro et al.…”

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confidence: 99%