Is Model-based Radiostereometric Analysis Suitable for Clinical Trials of a Cementless Tapered Wedge Femoral Stem?

Nazari-Farsani, Sanaz; Finnilä, Sami; Moritz, Niko; Mattila, Kimmo; Alm, Jessica J.; Aro, Hannu T.

doi:10.1007/s11999-016-4930-0

Cited by 16 publications

(18 citation statements)

References 29 publications

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“…When comparing these trials to the current study, the clinical precisions for translations are immediately comparable, while we found better precision for rotations. Clinical precision of model‐based RSA on the glenoid component of RTSA in our study was comparable to similar studies in hips and knees…”

Section: Discussionsupporting

confidence: 89%

Model‐based RSA is suitable for clinical trials on the glenoid component of reverse total shoulder arthroplasty

Fraser¹,

Tsukanaka

Fjalestad

et al. 2018

Journal Orthopaedic Research

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This study aims to validate model-based radiostereometric analysis (RSA) on the glenoid component of reversed total shoulder arthroplasty. We compared two different modalities of model-based RSA, elementary geometrical shapes and reversed engineering. We also explored two different ways to position the patient to obtain different projections of the implant, the hip-position (transversal) and shoulder-position (sagittal). Phantom accuracy was determined by performing nine translations (x, y, z) and five rotations (x, y, z), and expressed as the mean difference between RSA measurements and micrometer values. Precision was measured using 12 double examinations of the phantom and 19 in patients, and expressed as1.96 × standard deviations of the paired differences between double examinations. The accuracy was high for both modalities, but rotation around the symmetrical axis of the implant could not be measured using reversed engineering. Clinical precision ranged from 0.13 to 0.25 mm for translations, and 0.4° to 0.7° for rotations, using reversed engineering. For elementary geometrical shapes, the precision ranged from 0.18 to 0.34 mm for translations, and 0.8° to 1.8° for rotations. The hip-position was abandoned due to poor implant visualization. Model-based RSA on the glenoid component of reversed total shoulder arthroplasty has a high precision and accuracy, comparable to RSA results on hips and knees. Patient positioning is vital for obtaining adequate results. We found that reversed engineering was the more reliable method, and recommend reversed engineering as the method of choice for further clinical RSA investigation of the glenoid component of reversed total shoulder arthroplasty. © 2018 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res.

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Section: Discussionsupporting

confidence: 89%

Model‐based RSA is suitable for clinical trials on the glenoid component of reverse total shoulder arthroplasty

Fraser¹,

Tsukanaka

Fjalestad

et al. 2018

Journal Orthopaedic Research

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“…The secondary endpoint was the three‐dimensional migration of the femoral stem measured by model‐based radiostereometric analysis (RSA) at week 48. RSA is considered safe .…”

Section: Methodsmentioning

confidence: 99%

“…Stability and adequate distribution of bone markers were assessed by calculating mean error of rigid body fitting (upper limit ≤0.35) and condition number (upper limit ≤150) . The accuracy and precision of model‐based RSA was verified in a pretrial experiment using a phantom model . Clinical precision for each axis was determined based on double examinations of 58 trial subjects.…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2019

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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.

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“…The accuracy and precision of the applied model-based RSA technique was verified in a phantom model before the trial [15]. RSA was performed according to the RSA guidelines [16,17].…”

Section: Radiostereometric Analysismentioning

confidence: 99%

Bone Mineral Density and Cortical-Bone Thickness of the Distal Radius Predict Femoral Stem Subsidence in Postmenopausal Women

Nazari-Farsani

Vuopio

Aro

2020

The Journal of Arthroplasty

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Background: The distal radius is an optional site for evaluation of bone quality in postmenopausal women before cementless total hip arthroplasty. We hypothesized that dual-energy X-ray absorptiometry (DXA) and pulse-echo ultrasonometry of the distal radius may help discriminate subjects at high risk of femoral stem subsidence. Methods: A prospective cohort of postmenopausal women with primary hip osteoarthritis underwent total hip arthroplasty with implantation of a parallel-sided femoral stem. Postoperative stem migration was measured using radiostereometric analysis. Preoperatively, subjects had multisite DXA measurement of bone mineral density (BMD) and pulse-echo ultrasonometry of the cortical-bone thickness. The diagnostic abilities of these methods to discriminate <2 mm and !2 mm femoral stem subsidence were tested. Results: The accuracy of the distal radius BMD and cortical-bone thickness of the distal radius were moderate (area under the curve, 0.737 and 0.726, respectively) in discriminating between <2 mm and !2 mm stem subsidence. Women with low cortical-bone thickness of the radius were more likely (odds ratio ¼ 6.7; P ¼ .002) to develop stem subsidence !2 mm. These subjects had lower total hip BMD (P ¼ .007) and reduced thickness of the medial cortex of the proximal femur (P ¼ .048) with lower middle (P < .001) and distal (P ¼ .004) stem-to-canal fill ratios. Conclusion: Femoral stem stability and resistance to subsidence are sensitive to adequate bone stock and unaltered anatomy. DXA and pulse-echo ultrasonometry of the distal radius may help discriminate postmenopausal women at high risk of stem subsidence.

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Is Model-based Radiostereometric Analysis Suitable for Clinical Trials of a Cementless Tapered Wedge Femoral Stem?

Cited by 16 publications

References 29 publications

Model‐based RSA is suitable for clinical trials on the glenoid component of reverse total shoulder arthroplasty

Model‐based RSA is suitable for clinical trials on the glenoid component of reverse total shoulder arthroplasty

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

Bone Mineral Density and Cortical-Bone Thickness of the Distal Radius Predict Femoral Stem Subsidence in Postmenopausal Women

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