Radiographic Fit and Fill Analysis of a New Second-Generation Proximally Coated Cementless Stem Compared To Its Predicate Design

Issa, Kimona; Pivec, Robert; Wuestemann, Thies; Tatevossian, Tiffany; Nevelos, Jim; Mont, Michael A.

doi:10.1016/j.arth.2013.04.029

Cited by 57 publications

(64 citation statements)

References 42 publications

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“…Many studies deal with the influences of FFR on longevity of femoral stems [3,5,6,11,14,15,24], but this is the very first study which investigates the effects of FFR of a cementless short-stem prosthesis clinically and radiologically.…”

Section: Discussionmentioning

confidence: 99%

“…This procedure was applied preoperatively, and at every follow- Fig. 1 Measuring level of FFR at the proximal level, the mid-stem and the distal level according to Issa [5]. FFR resulted from measurements of the proximal medial gap (P mg ), the lateral (M lg ) and medial (M mg ) mid-stem gaps and the lateral (D lg ) and medial (D mg ) distal gaps Arch Orthop Trauma Surg up to ensure the same neutral zero hip position of each patient.…”

Section: Clinical and Radiological Examinationmentioning

confidence: 99%

“…The distal level was set 10 mm above the stem tip and the mid-stem level was set halfway between stem shoulder and the height of the distal measurement level. FFR was measured and calculated using a modified method according to Issa [5] (Fig. 1).…”

Section: Clinical and Radiological Examinationmentioning

confidence: 99%

“…Geometry, design criteria, stem sizing and preparing of the medullary canal influence the load transfer into the bone and its remodeling processes [2] and may affect clinical outcome [3][4][5]. Additional factors contributing to longevity of cementless total hip arthroplasty (THA) are the bone stock quality and the material properties of the implant for physiologically optimizing proximal load initiation [4].…”

Section: Introductionmentioning

confidence: 99%

“…For non-cemented prostheses, primary stability relies on maximum implant fit and fill to decrease stress shielding and micromovement to ensure long-term fixation [7]. Numerous cementless standard and custom made stems have been developed to examine their biological migration depending on their initial fit and fill ratios (FFR) in order to find an optimized stem design [1,3,5,6,[9][10][11][12][13][14][15] but there is no ideal stem regarding longevity and implant fit and fill [5]. In a previously published study [16], we examined the concept of proximal load initiation of the Metha Ò (BBraun, Aesculap, Tuttlingen, Germany) short-stem prosthesis by means of bone mineral density [BMD (g/cm 2 )] changes and radiological measurements.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Influences of fit and fill following hip arthroplasty using a cementless short-stem prosthesis

Jahnke

Engl

Seeger

et al. 2015

Arch Orthop Trauma Surg

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Implanting the Metha prosthesis induces tight fit and fill ratio at the proximal and coated sections. Preoperative femur configuration should be considered to achieve best fit and fill situation and therefore excellent primary stability. In most cases "normal" and "stove-pipe" configurations provide good proximal fit and fill. Since "champagne-flute" configuration induces undesirable tight distal fit and fill ratio the size of the Metha (®) stem should be adequately increased to achieve a more proximal load transmission.

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Section: Discussionmentioning

confidence: 99%

Section: Clinical and Radiological Examinationmentioning

confidence: 99%

Section: Clinical and Radiological Examinationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Influences of fit and fill following hip arthroplasty using a cementless short-stem prosthesis

Jahnke

Engl

Seeger

et al. 2015

Arch Orthop Trauma Surg

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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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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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Radiographic Fit and Fill Analysis of a New Second-Generation Proximally Coated Cementless Stem Compared To Its Predicate Design

Cited by 57 publications

References 42 publications

Influences of fit and fill following hip arthroplasty using a cementless short-stem prosthesis

Influences of fit and fill following hip arthroplasty using a cementless short-stem prosthesis

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

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

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