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Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 103 - 103
1 Apr 2019
Westrich GH Swanson K Cruz A Kelly C Levine A
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INTRODUCTION

Combining novel diverse population-based software with a clinically-demonstrated implant design is redefining total hip arthroplasty. This contemporary stem design utilized a large patient database of high-resolution CT bone scans in order to determine the appropriate femoral head centers and neck lengths to assist in the recreation of natural head offset, designed to restore biomechanics. There are limited studies evaluating how radiographic software utilizing reference template bone can reconstruct patient composition in a model. The purpose of this study was to examine whether the application of a modern analytics system utilizing 3D modeling technology in the development of a primary stem was successful in restoring patient biomechanics, specifically with regards to femoral offset (FO) and leg length discrepancy (LLD).

METHODS

Two hundred fifty six patients in a non-randomized, post-market multicenter study across 7 sites received a primary cementless fit and fill stem. Full anteroposterior pelvis and Lauenstein cross-table lateral x-rays were collected preoperatively and at 6-weeks postoperative. Radiographic parameters including contralateral and operative FO and LLD were measured. Preoperative and postoperative FO and LLD of the operative hip were compared to the normal, native hip. Clinical outcomes including the Harris Hip Score (HHS), Lower Extremity Activity Scale (LEAS), Short Form 12 (SF12), and EuroQol 5D Score (EQ-5D) were collected preoperatively, 6 weeks postoperatively, and at 1 year.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 131 - 131
1 Feb 2017
Garcia-Rey E Cimbrelo EG Cruz-Pardos A
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Background and aim

A significant reduction in wear using Durasul highly cross-linked polyethylene (PE) versus Sulene polyethylene (sterilized with nitrogen) at 5 and 10 years have been reported previously. We ask if the improvement observed at the earlier follow-up continues at 15 years.

Methods

Between 1999 and 2001, 90 hips underwent surgery using the same cementless cup and stem: 45 received Allofit cups with a Sulene-PE liner and 45 Allofit cups with a Durasul-PE liner, both associated with an Alloclassic stem (28 mm metallic femoral head). 66 hips of this prospective comparative study were available over a minimum follow-up of 15 years. Linear femoral head penetration was estimated digitally at 6 weeks, at 6 and 12 months and annually thereafter, using the Dorr method, given the nonspherical cup shape. All radiographs were evaluated by the same author, who was not involved in surgery.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 85 - 85
1 Feb 2017
Cruz A Perona P Cohen R Campbell D
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Background

Instability and dislocation are some of the most important postoperative complications and potential causes of failure that dual mobility total hip arthroplasty (THA) systems continue to address. Studies have shown that increasing the relative head size provides patients implanted with smaller and larger cups increased stability, greater ROM and a lesser incidence of impingement, without compromising clinical results. The purpose of the current study was to review clinical outcomes in three groups of primary THA patients receiving a dual mobility acetabular shell.

Methods

In two US based, post-market, multicenter studies, 450 patients received a primary cementless dual mobility THA. Patients were split into three groups based on cup size: ≤ 50mm, 52mm–56mm, and ≥ 58mm. Harris Hip Scores (HHS), Short Form 12 Physical Components (SF12 PCS), Lower Extremity Activity Scores (LEAS), and Euroqol 5D Score (EQ-5Ds) were collected preoperatively and through 2 years postoperative.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 249 - 249
1 Jul 2011
Hurtig M Fischer L Cruz A David F
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Purpose: To determine if an adenovirus vector expressing BMP-7 can alter the progression of post-traumatic osteoarthritis.

Method: Preliminary dose-response studies were done in ovine metacarpal-phalangeal joints using 10^9, 10^10, and 10^11 virus particles (VP). In-vitro transfection efficiency studies were done using ovine synovial cells, chondrocytes and HEK293 cells. In-vivo studies were conducted in 16 sheep that underwent surgery to create bilateral contusive impact injuries to the medial femoral condyle. One week later 10^9 VP were injected into one joint of each sheep, while four sheep remained untreated bilateral controls. Three months later the sheep were sacrificed for assessments including histological scoring, cartilage glycosaminoglycan assays, and immunostaining for Col2 3/4 short collagen fragments that are generated by metalloproteinases during OA progression.

Results: Transfection with 10^9 VP produced slightly longer expression than higher concentrations of VP. HEK293 cells expressed BMP-7 quickly but synoviocytes and chondrocytes expressed this protein at 48 and 96 hours. Knee joints that received Ad5-BMP-7 produced up to 2.5 ng of BMP-7 between day seven and 21. These joints had reduced cartilage degneration at the injury sites and less centrifugal progression of OA across the femoral condyle. Histological scores were reduced as was Col2 C3/4 short immunostaining.

Conclusion: BMP-7 has a homeostatic role in cartilage and can be used therapeutically1. Ad5-BMP-7 transfection of synovial tissue produced sufficient BMP-7 to stop the progression of degenerative changes after trauma that would usually lead to OA. Adenoviral vectors can create inflammation and neutralizing antibodies but these complications were minimized by using a low (10^9) dose. Human trials using similar vectors are ongoing and the outcome of these will determine whether gene therapy will become a useful tool when patients are at risk of post-traumatic OA.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 129 - 129
1 May 2011
García-Rey E Garcia-Cimbrelo E Cruz-Pardos A
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Acetabular bone structure is not the same in all patients and can be defined by the radiolucent triangle superior to the acetabulum. We ask if the acetabular anatomy determines the initial cup fixation and screws use.

We have assessed 205 hips in which a Cerafit cementless cup was implanted. According to Dorr et al., acetabulae were classified as type A, in which the radiolucent triangle had an isosceles shape (86 hips), type B, in which the triangle extended into the teardrop (90 hips), and type C which had a right-angle triangle (29 hips). The use of screws was decided at the time of surgery and according to cup stability, not acetabular anatomy.

Avascular necrosis and inflammatory arthritis were the most frequent diagnoses in type A hips, osteoarthritis in type B, and dysplasia in type C. Women were more frequent in types A and C (p< 0.001). The use of screws was more frequent in women (p< 0.001) and in type A (34.9%) and type C hips (62.1%) than in type B hips (20.0%) (p< 0.001). The multivariate logistic regression model showed the acetabular type (p=0.11) and gender (p=0.003) as independent factors. Acetabular types A (OR=1.98, 95% CI: 0.922–4.208, p=0.075) and C (OR=5.09, 95% CI: 1.74–14.9, p=0.003) increase the risk for screw use. Men have a lower risk for screw use (OR=0.329, 95% CI: 0.16–0.68, p=0.003).

Acetabular anatomy and gender determine the use of screws in cementless cups. Continued follow-up is necessary to determine if screws results in less loosening and osteolysis.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 515 - 515
1 Oct 2010
Garcia-Cimbrelo E Cruz-Pardos A Garcia-Rey E
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Introduction: Severe stress shielding and radiographic cortical changes in the proximal femur are frequent after extensively porous-coated stem in revision surgery. We have analyzed the evolution of the femoral cortex at different levels and related factors.

Material and Methods: We assessed 95 extensively porous-coated stems in revision surgery with a minimum 5-year follow-up (Mean 10.2 years). 77 hips were revised due to aseptic loosening and 18 due to periprosthetic fractures. Extended osteotomy was used in 29 hips. No cortical struts were used. Preoperative and postoperative osteoporosis was graded according to Moreland and bone defect according to Paprosky. Femoral cortex width was measured at different levels in the immediate postoperative radiograph, at 3, 6 and 12 months and at the last follow-up.

Results: There were 2 re-revisions for aseptic loosening. Radiographic ingrowth fixation was more frequent in minor intraoperative bone defects (p=0.011). Preoperative osteoporosis was related to the width of the medial and lateral cortex. Medial cortical thickness increased at different levels with a mean increase of 13.4% (p< 0.001) and the lateral cortical thickness showed a mean decrease of 2.7% at the proximal level. The femoral medial cortex tended to show a higher slope trend in periprosthetic fractures (p=0.015). The outside femoral diameter increased more rapidaly with an extended trochanteric osteotomy (p=0.007). The slope trend of the lateral and medial cortex was significantly higher at proximal levels in hips with a 10-inch stem (p=0.015).

Conclusions: Although without clinical relevance at the end of follow-up, femoral medial cortical thickness increased while frequently lateral cortical thickness decreased over time after an extensively porous -coated stem in revision hip surgery.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 318 - 318
1 May 2009
Garcia-Rey E García-Cimbrelo E Cruz A Ortega-Chamarro J
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Introduction and purpose: Highly cross-linked polyethylenes (HXLPE) sterilized in an air-free environment have been used to prevent osteolysis and loosening of implants. This prospective randomized study analyzes the results of a series in which one single type of prosthesis but made with one of two different kinds of polyethylene (PE) has been used.

Materials and methods: We assessed 45 Allofit cups with a Sulene-PE liner (sterilized in nitrogen) and 45 with Durasul-PE liner (highly cross-linked) associated with an Alloclassic stem (femoral head: 28 mm) with a minimum follow-up of 5 years (mean 66.3 months). Femoral head penetration was analyzed by means of a digital program at 6 weeks, and at 6 and 12 months and once a year, using the Dorr method given the non-spherical shape of the cups.

Results: All assessed hips had good outcomes determined clinically and by x-rays. There was no loosening of any component. There were no radiolucent lines or osteolysis. Femoral head penetration at 6 weeks was 47.4% less in the Durasul group (0.19+0.06 mm for the Sulene-PE and 0.09+0.03 for the Durasul-PE [p< 0.0001]). Mean annual penetration was 20% less in the Durasul group (0.04+0.02 and 0.008+0.008 [p< 0.0001] respectively. The differences increased by the third year. Mean penetration at 5 years was 39.1% less in the Durasul group (p< 0.0001).

Conclusions: There was significant femoral reduction in the Durasul-PE group. Long term results are necessary to confirm that these prostheses lead to a lower rate of osteolysis.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 65 - 65
1 Mar 2009
Garcia-Rey E Garcia-Cimbrelo E Ortega-Chamarro J Cruz-Pardos A Sanchez J
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Introdution. Gamma sterilisation in air produces free radicals in the polyethylene (PE) with the result of degrading its mechanical properties, increasing wear and debris, and producing osteolysis and loosening. PE sterilized in the absence of air and high cross-linked polyethylene (HXLPE) have been used to avoid osteolysis and loosening. This prospective randomized study has assessed results in a series using two different poly-ethylenes associated with the same prosthetic design.

Methods: We assessed 45 Allofit cups with Sulene-PE liner (sterilized with nitrogen) and 45 Allofit cups with Durasul-PE liner (HXLPE), both associated with an Alloclassic stem (28-mm femoral head) (Zimmer). The minimum follow-up is 5 years and the mean follow-up 66.3 months. The linear femoral head penetration was estimated at 6 weeks, at 6 and 12 months and annually thereafter, using a software package employing the Dorr method, given the nonspherical cup shape.

Results All assessed hips had good clinical and radiographic results. There was no loosening of any prosthetic component. There were no radiolucent lines or osteolysis. Femoral head penetration in the early postoperative radiographs was 47.4% less in the Durasul group (0.09+0.03 mm) than the Selene-PE group (0.19+0.06 mm)(p< 0.0001). The mean yearly linear femoral head penetration was 20% lower in the Durasul group (0.008+0.008) than the Sulene-PE group (0.04+0.02)(p< 0.0001). Differences increase after the third year. Mean linear femoral head penetration at 5 years was 39.1% less in the Durasul group (p< 0.0001).

Conclusions: Although the digitized method used is not totally accurate and is used only for a general estimate, there is a significant reduction in yearly linear femoral head penetration with Durasul-PE. Longer-term results are needed to confirm that this polyethylene generates less osteolysis.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 44 - 44
1 Mar 2006
García-Rey E Garcia-Cimbrelo E Cruz-Pardos A De La Cerda J
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Aim: We assessed prospectively clinical and radiographic results of two different polyethylenes (PE) associated with the same prosthetic design (Zimmer-Centerpulse).

Material and Methods: We assessed 56 Allofit cups with Sulene-PE liner (sterilized in nitrogen) and 45 with Durasul-PE liner (highly cross-linked) associated with an Alloclassic stem (28-mm femoral head) implanted between 1999–2002. The mean follow-up was 29.4 months for the Sulene-PE and 25.3 for Durasul-PE. The radiologic study according to Johnston et al. and the PE wear estimated according to a software package (AutoCAD R14), were analysed at 6 weeks (zero position), at 6 and 12 months and annually thereafter.

Results: There were 3 dislocations which were excluded from the follow-up study. There were no infections. All assessed hips had good clinical and radiographic results. There was no loosening of any prosthetic component. There were no radiolucent lines, osteolysis, cortical hypertrophy, or femoral osteopenia. The distances between the acetabular shell and the femoral head centres taken in the early postoperative radiographs (zero position or bedding-in) were 0.30+0.094 mm for the Sulene-PE group and 0.20+0.074 for the Durasul-PE (p=0.029). The mean wear related with the zero position was 0.1035+0.0686 and 0.0819+0.078 (p=0.108) respectively.

Conclusions: Despite the measurement error of PE wear being higher in the Allofit cup, a higher zero position (bedding-in) was found in the Sulene-PE group than in the Durasul-PE. Although the mean wear was higher in the Sulene-PE than in the Durasul-PE, with the number of hips available, differences were not significant after 3 years


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_I | Pages 85 - 85
1 Mar 2005
García-Cimbrelo E Cruz-Pardos A Ortega-Chamarro J Castro-García F
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Introduction and purpose: This is a prospective analysis of the clinical and radiographical results of two different types of PE, both associated to the same kind of prosthesis (Zimmer-Centerpulse).

Materials and methods: A total of 101 Allofit shells were analyzed; 56 had Sulene-PE (nitrogen sterilized) and 45 had Durasul highly cross-linked PE, associated to an Alloclassic stem (femoral head: 28 mm). They were all implanted between 1999 and 2002. Mean follow-up was 29.4 months for Sulene-PE and 25.3 for Durasul-PE. PE wear was assessed by means of image digitalization with special software (AutoCAD 14R) after six weeks (initial settling or position zero), after 6 and 12 months and on a yearly basis.

Results: Three cases dislocated and were thus excluded from the study. There were no infections. All cases assessed had good clinical and radiological results. There were no instances of implant loosening. There were no radiolucent lines, osteolysis, cortical hyperthrophy or proximal osteopenia. On the initial radiograph (position zero), the distance between the axes of the femoral head and those of the shell was 0.30+0.094 mm for the Sulene-PE group and 0.20+0.074 for the Durasul-PE one (p=0.029). Mean wear, taking position zero as a reference point, was 0.1035+0.0686 and 0.0819+0.078 (p=0.108) respectively.

Conclusions: In spite of the higher error rates found in the wear measurements of the Allofit cup, a greater position zero was found in Sulene-PE than in Durasul-PE. Although mean wear was higher in Sulene-PE than in Duarsul-PE, the differences found were not significant 3 years postop.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 378 - 378
1 Mar 2004
Garc’a-Cimbrelo E Cruz-Pardos A Cordero J Munuera L
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Aim: To assess the long-term results of a series of porous-coated anatomic cementless total hip prostheses. Material and Methods: A total of 91 PCA (How-medica) total hip arthroplasties performed between 1984–1988 were analyzed with a mean follow-up of 13.5 years. Clinical results were assessed according to Merle DñAubignŽ-Postel score. Radiographic þxation was assessed according to Engh et al. Results:Thigh pain (17 hips) was correlated with unstable þxation (p=0.0096). Thirty-one cups and six stems were revised. Radiographic loosening ocurred in 21 cups and 12 stems. Mean polyethylene wear was 0.16 mm/year. Cup loosening was related with an acetabular wear equal to or more than 2 mm (p=0.0018) and an small cup size (p=0.015). Stem loosening was related with poor femoral canal þlling (p=0.046). Fifty (54.9%) hips had femoral osteolysis and were related with polyethylene wear of more than 2 mm (p=0.0015) and with hips with poor femoral þlling (p=0.0285) and unstable þxation (p=0.00005). Conclusions:The PCA cup has had worse results than the stem. Cup loosening is related with the acetabular wear and cup size. The frequent proximal femoral osteolysis is associated with unstable þxation and poor femoral þlling