Dataset Information

Comparison of two metaphyseal-fitting (short) femoral stems in primary total hip arthroplasty: study protocol for a prospective randomized clinical trial with additional biomechanical testing and finite element analysis.

ABSTRACT:

Background

Total hip replacement has recently followed a progressive evolution towards principles of bone- and soft-tissue-sparing surgery. Regarding femoral implants, different stem designs have been developed as an alternative to conventional stems, and there is a renewed interest towards short versions of uncemented femoral implants. Based on both experimental testing and finite element modeling, the proposed study has been designed to compare the biomechanical properties and clinical performance of the newly introduced short-stem Minima S, for which clinical data are lacking with an older generation stem, the Trilock Bone Preservation Stem with an established performance record in short to midterm follow-up.

Methods/design

In the experimental study, the transmission of forces as measured by cortical surface-strain distribution in the proximal femur will be evaluated using digital image correlation (DIC), first on the non-implanted femur and then on the implanted stems. Finite element parametric models of the bone, the stem and their interface will be also developed. Finite element predictions of surface strains in implanted composite femurs, after being validated against biomechanical testing measurements, will be used to assist the comparison of the stems by deriving important data on the developed stress and strain fields, which cannot be measured through biomechanical testing. Finally, a prospective randomized comparative clinical study between these two stems will be also conducted to determine (1) their clinical performance up to 2?years' follow-up using clinical scores and gait analysis (2) stem fixation and remodeling using a detailed radiographic analysis and (3) incidence and types of complications.

Discussion

Our study would be the first that compares not only the clinical and radiological outcome but also the biomechanical properties of two differently designed femoral implants that are theoretically classified in the same main category of cervico-metaphyseal-diaphyseal short stems. We can hypothesize that even these subtle variations in geometric design between these two stems may create different loading characteristics and thus dissimilar biomechanical behaviors, which in turn could have an influence to their clinical performance.

Trial registration

International Standard Randomized Controlled Trial Number, ID: ISRCTN10096716 . Retrospectively registered on May 8 2018.

SUBMITTER: Tatani I

PROVIDER: S-EPMC6580512 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Publications

Comparison of two metaphyseal-fitting (short) femoral stems in primary total hip arthroplasty: study protocol for a prospective randomized clinical trial with additional biomechanical testing and finite element analysis.

Tatani I I Panagopoulos A A Diamantakos I I Sakellaropoulos G G Pantelakis Sp S Megas P P

Trials 20190617 1

<h4>Background</h4>Total hip replacement has recently followed a progressive evolution towards principles of bone- and soft-tissue-sparing surgery. Regarding femoral implants, different stem designs have been developed as an alternative to conventional stems, and there is a renewed interest towards short versions of uncemented femoral implants. Based on both experimental testing and finite element modeling, the proposed study has been designed to compare the biomechanical properties and clinical ...[more]

PMID: 31208433

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Project description:BACKGROUND:The progressive evolution in hip replacement research is directed to follow the principles of bone and soft tissue sparing surgery. Regarding hip implants, a renewed interest has been raised towards short uncemented femoral implants. A heterogeneous group of short stems have been designed with the aim to approximate initial, post-implantation bone strain to the preoperative levels in order to minimize the effects of stress shielding. This study aims to investigate the biomechanical properties of two distinctly designed femoral implants, the TRI-LOCK Bone Preservation Stem, a shortened conventional stem and the Minima S Femoral Stem, an even shorter and anatomically shaped stem, based on experiments and numerical simulations. Furthermore, finite element models of implant-bone constructs should be evaluated for their validity against mechanical tests wherever it is possible. In this work, the validation was performed via a direct comparison of the FE calculated strain fields with their experimental equivalents obtained using the digital image correlation technique. RESULTS:Design differences between Trilock BPS and Minima S femoral stems conditioned different strain pattern distributions. A distally shifting load distribution pattern as a result of implant insertion and also an obvious decrease of strain in the medial proximal aspect of the femur was noted for both stems. Strain changes induced after the implantation of the Trilock BPS stem at the lateral surface were greater compared to the non-implanted femur response, as opposed to those exhibited by the Minima S stem. Linear correlation analyses revealed a reasonable agreement between the numerical and experimental data in the majority of cases. CONCLUSION:The study findings support the use of DIC technique as a preclinical evaluation tool of the biomechanical behavior induced by different implants and also identify its potential for experimental FE model validation. Furthermore, a proximal stress-shielding effect was noted after the implantation of both short-stem designs. Design-specific variations in short stems were sufficient to produce dissimilar biomechanical behaviors, although their clinical implication must be investigated through comparative clinical studies.

Project description:BACKGROUND:Free vascularized fibula graft (FVFG) techniques have most consistently demonstrated beneficial effects in young patients diagnosed with nontraumatic osteonecrosis of the femoral head (NONFH), and the core track technique (CTT) in particular is the most commonly used technique. As an alternative to CTT, the modified light bulb technique (LBT) has been reported to have a higher success rate. However, its biomechanical outcomes are poorly understood. This study aimed to compare the biomechanical properties of modified LBT with those of CTT in treating NONFH. METHODS:Two types (C1 and C2) of NONFH finite element models were established on the basis of a healthy subject and the Japanese Investigation Committee (JIC) classification system, and the CTT and LBT procedures were simulated in each type of model. The average von Mises stresses and stiffness of the proximal femur were calculated by applying a load of 250% of the body weight on the femoral head to simulate walking conditions. In addition, two patient-specific models were built and simulated under the same boundary conditions to further validate the LBT. RESULTS:In the healthy subject-derived models, both the LBT and CTT resulted in reduced stresses in the weight-bearing area, central femoral head, femoral neck, and trochanteric and subtrochanteric regions and increased structural stiffness after surgery. In the weight-bearing area, the CTT reduced the stress more than the LBT did (36.19% vs 31.45%) for type C1 NONFH and less than the LBT did (23.63% vs 26.76%) for type C2 NONFH. In the patient-specific models, the stiffness and stresses also increased and decreased, respectively, from before to after surgery, which is consistent with the results of healthy subject-derived models. CONCLUSION:The biomechanical effects of the LBT and CTT differ by the JIC type of NONFH. In terms of preventing the collapse of the femoral head, the LBT may be more effective for JIC type C2 NONFH and may be a suitable alternative to the CTT, while for JIC type C1 NONFH, the CTT is still a better choice. Both techniques can improve the biomechanical properties of NONFH by reducing the proximal femoral stress and increasing the structural stiffness.

Project description:BackgroundThe introduction of new devices for total hip arthroplasty (THA) offers surgeons the ability to address deficits in the portfolio. However, once introduced, data regarding the performance of devices is not publicly available until their use is widespread.Purpose/questionsThe objective of this study was to compare the clinical and radiographic performance, including patient reported outcomes and radiographic evidence of osseointegration, subsidence, and stress shielding, of the newer Actis femoral component to the Corail stem (DePuy Synthes, Warsaw, IN, USA), which has an extensive clinical history.MethodsThis short-term, retrospective cohort study was a single surgeon series of 330 anterior approach THAs, consisting of 165 cases using the Actis stem and 165 cases using the Corail stem. Both devices were cementless, titanium, tapered, hydroxyapatite-coated stems. They differed in geometry, neck choices, broach philosophy, and collar availability. Data was obtained for 1 year following THA. Functional outcomes were measured with the Hip Dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.) survey. Complications were recorded from patient charts, and radiographic analysis was performed for signs of osseointegration, subsidence, and stress shielding.ResultsThe groups shared similar demographic characteristics except the Actis population was younger with fewer women. The complication rate did not significantly vary, and no patient required revision within the first year. Radiographically, one patient in each group demonstrated subsidence. No cases exhibited radiolucent lines, and the prevalence of stress shielding at 1 year was comparable. HOOS, JR. scores did not significantly vary at 8 weeks or 1 year.ConclusionThe Actis stem does not carry an increased risk of device-related complications compared with the Corail implant. Although aspects of bone remodeling differed between groups, Actis achieved radiographic signs of bone ingrowth at the 1-year mark and performed well clinically, with equivalent patient reported outcome scores to the Corail stem.

Dataset Information

Comparison of two metaphyseal-fitting (short) femoral stems in primary total hip arthroplasty: study protocol for a prospective randomized clinical trial with additional biomechanical testing and finite element analysis.

Background

Methods/design

Discussion

Trial registration

Publications

Comparison of two metaphyseal-fitting (short) femoral stems in primary total hip arthroplasty: study protocol for a prospective randomized clinical trial with additional biomechanical testing and finite element analysis.

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