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Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 14 - 14
1 Jan 2016
Grosser D Mercer G Wilson C Nilsson K Krishnan J
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Background. Safety and efficacy of novel prostheses relies on the determination of early implant migration and subsequent risk of loosening. Radiostereometric Analysis (RSA) has been used to evaluate the clinical failure risks of femoral stems by reporting distal migration, a measure of stem subsidence, when examining early migration characteristics. The migratory patterns of femoral stems, 24 months postoperatively, have provided a surrogate outcome measure to determine implant stabilisation and predict long-term performance and survivorship. RSA assessed femoral stem migration and provided comparison of the early migration characteristics with published data of a clinically established counterpart. Methods. Twenty five patients undergoing primary total hip arthroplasty were implanted with a hydroxyapatite-coated femoral stem. The median age was 65 years (range, 43–75 years). During surgery tantalum markers were attached onto the distal tip and shoulder of the stem. Eight tantalum markers were inserted into the femur, four placed in each of the greater and lesser trochanter. RSA examinations were performed postoperatively at 4 to 5 days, 6, 12 and 24 months. Eleven patients who had complete RSA follow-up as well as the valid data from five patients were analysed to determine the movement of the femoral stem relative to the femur and were compared to the published data of a clinically established counterpart. Results. At 24 months the magnitude of migration of the femoral stem translations for the y axis of movement was 0.32 mm (range, 0.00 to 2.04 mm) (Figure 1). The data demonstrates that this migration of the femoral stem occurred primarily in the first 6 months postoperatively and that the migration characteristics exhibit a pattern of implant stabilisation between 6 and 24 months. At 24 months the magnitude of migration of the femoral stem rotations for the longitudinal y axis of movement was 0.60. o. (range, 0.08 to 2.08. o. ). The data demonstrates continuing migration of the femoral stem at 12 months postoperatively with early indications of implant stabilisation between 12 and 24 months. At 24 months the mean subsidence/distal migration of the femoral stem was 0.20 mm (range, −2.04 to 0.32 mm) (Figure 2). At 6 months, two patients (12.5%) exhibited subsidence greater than 0.50 mm with one demonstrating a mean subsidence of 2.00 mm. Between 6 and 24 months these two patients exhibited no more than 0.04 mm of subsidence (Figure 3). The mean retroversion rotation of the stem was 0.10. o. (range, −0.99 to 2.08. o. ). One patient rotated more than 2.00. o. into retroversion at 12 and 24 months postoperatively. Conclusions. In comparison the data demonstrates less stem subsidence and retroversion rotation than published data for a cementless hydroxyapatite-coated femoral stem when observing early migration characteristics. The magnitude and pattern of migration exhibited is indicative of good clinical outcomes and is comparable with a clinically established counterpart after short-term follow-up with RSA. These findings and comparisons highlight the early migration characteristics of a hydroxyapatite-coated femoral stem, however the analysis and comparison of the migratory pattern and characteristics over the mid-term follow-up will confirm implant stabilisation


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 10 - 10
1 Feb 2020
Haffner N Auersperg V Mercer S Koenigshofer M Rattinger H Ritschl P
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INTRODUCTION. Cementless femoral component designs supplemented with hydroxyapatite (HA) coating have been hypothesised to enhance osseointegration, thereby improving stability and clinical outcomes. We herein offer interim results at 5 years from a prospective, multi-centre study of a femoral stem (SL-PLUS™ Hip Stem Prosthesis), forged from titanium alloy (Ti6Al7Nb) and consisting of a titanium plasma sprayed coating (0.3mm) with an additional 0.05mm layer of HA. METHODS. Investigators at 2 centres enrolled patients between 18–75 years of age who underwent primary total hip arthroplasty (THA) with this HA-coated stem. The study's primary outcome was the clinical efficacy of the stem, as measured by the Harris Hip Score (HHS), Western Ontario & McMaster Universities Osteoarthritis (WOMAC) Score calculated out of Hip Disability and Osteoarthritis Outcome Score (HOOS), and the EuroQol EQ-5D-3L index score and visual analogue scale (VAS). Its secondary outcomes included a radiographic assessment of implant position and fixation, and overall safety, as measured by intraoperative/early postoperative complications and survivorship calculated using Kaplan-Meier estimates. RESULTS. Ninety-three patients (94 hips) were enrolled in the study. At the time of surgery, the study population had a mean age of 60.1 years (standard deviation [SD], 8.4), a mean body mass index of 27.9 kg/m. 2. (SD, 4.75), and 54.8% were female. Indications for surgery include primary osteoarthritis (74.5%), dysplasia (17.5%), femoral head necrosis (6.4%), and other (2.1%). Patients were followed up through 5 years in the ongoing safety and performance analysis. Between preoperative baseline and final follow up, there were notable improvements in the mean scores for all primary clinical outcomes: HHS (51.6 to 91.4, respectively), WOMAC from HOOS (42.6 to 91.0, respectively), mean EQ-5D-3L index score (0.7 to 0.9, respectively), and EQ-5D-3L VAS (54.7 to 80.2, respectively). The majority of patients rated their satisfaction as excellent (84.2% of treated hips), with an additional 14.5% of treated hips being mostly satisfied. Five years after surgery, radiographic findings showed an overall stability of the device, with 100% unchanged stem positions (no movement in varus/valgus or subsidence) and no stem was classified as loose. Intraoperative complications were observed in 3 patients (3.2%), consisting of 2 cases of trochanteric fracture and 1 case of leg lengthening. There were no general early postoperative complications reported in any patient. Two revision surgeries of the study device were reported, both due to infection, resulting in a survivorship of 97.5% (95% confidence interval: 90.3% – 99.4%) at 5 years. CONCLUSION. These results confirm the safety and efficacy of this HA-coated femoral stem at 5 years. All clinical outcomes showed significant improvement between baseline and midterm follow up, with mean HHS in particular meeting the 90-point range considered “excellent.” Additionally, revision rates met the accepted benchmarks for a successful THA device. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IV | Pages 77 - 77
1 Mar 2012
Vidalain J
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Introduction. Bio-active fixation has increasingly gained acceptance over the last two decades. However extent of the coating is still a subject of debate. We introduced in 1986, the concept of total osteointegration of a tapered stem with the hope that we could achieve durable biological fixation while preserving normal periprosthetic bone trophicity. Material and methods. Patients from our first clinical series using this stem are now eligible for 18-year follow up. Between July 1986 and December 1990, we performed 615 THA using the Corail stem (DePuy). Corail is a straight tapered stem totally coated with a 150 μ thick layer of HA following an atmospheric plasma-spray process. The mean age at surgery was 64.5 (range 16 to 95). 242 patients are now deceased (39%), 62 patients (10%) are lost to follow-up. The mean follow-up for 243 living patients on file is 17.7 years. Results. 89 THAs required component revisions: 72 cups, 9 stems, 8 “cups and stems”. 8 cups and 4 stems have been revised for aseptic loosening. Owing to the high incidence of wear-related revision, Kaplan-Meïer survivorship at 18-year follow-up, using component revision for any reason as an endpoint, was 80.7 ± 3.3 (95% confidence intervals). In contrast, Corail stem survivorship, using stem removal for any reason as an endpoint, was 95.0% ± 3.0 at 18-year follow-up, and considering aseptic loosening only, the survival probability of the stem is 98.9% ± 1.1 at 18 years. Discussion and conclusions. Therefore, despite wear and proximal osteolysis, the fixation achieved with this totally HA-coated stem remained durable through 18-year follow-up. Regarding the periprosthetic remodelling during this period, modifications of the bone pattern have been strictly limited: slight resorption at the calcar level, absence of cortical hypertrophy, anecdotic significant stress-shielding. The radiological silence is one of the paramount facts demonstrated by this prospective study


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 8 - 8
1 Apr 2019
Wilson C Critchely O Callary S Campbell D
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Introduction & aims

The magnitude and pattern of acceptable migration in clinically successful cementless stems is not well understood. Radiostereometric analysis (RSA) is a well-recognised method of assessing implant migration.

Previous studies have reported long term RSA results for cemented stems. The aim of this study was to assess the long-term migration characteristics of the Corail hydroxyapatite-coated cementless stem at 10 years using RSA.

Method

A prospective cohort of 30 patients undergoing primary total hip arthroplasty for primary hip osteoarthritis were enrolled into a study to characterise the migration behaviour of a cementless stem. Tantalum markers were attached to the stem and placed in the bone intraoperatively, allowing for RSA measurements to be taken in vivo. Previous 5-year results have been presented.

A total of 14 patients (total 15 hips, one bilateral) with mean age 82 years (range, 69–92 years) underwent repeat long-term RSA radiographs at minimum 10 years post op. The mean time to follow up was 13.9 years (range, 13.3–14.4 years). The RSA radiographs were analysed to assess for implant rotation and translation.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 25 - 25
1 Mar 2017
Mitsui H Sugimoto K Sakamoto M
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Introduction

Achieving primary and long-term stability of femoral implant is critical for THA. This can be influenced by the shape and location of surface preparation as well as geometry. The Corail® stem has developed in 1986 in France, which is a straight quadrangular, and full HA coated standard titanium alloy stem featuring a metaphyseal tulip flare in combination with horizontal and vertical grooves. We have performed 75 THAs using it since May 2013. The purpose of this study was to evaluate radiographic changes of femur over time in Japanese patients after THA using this HA coated stem.

Materials and Methods

Between May 2013 and September 2015, we implanted 75 THAs using a Corail® stem (DePuy-Synthes) in 66 patients. Their ages at operation were 47 to 93 years (avg. 66.5 years). Durations of follow up were 6 to 34 months after implantation (avg. 13.7 months). Acetabular components were standard titanium alloy, either 37 Pinnacle Porocoat®, 19 Pinnacle Gription® (DePuy-Synthes), 8 Ranawat®, 5 Regenerex®, or 6 G7® (Zimmer-Biomet) uncemented cups. Heads were either 73 BIOLOX delta® ceramic (CeramTec) or 2 CoCr. Liners were either 56 Marathon® (DePuy-Synthes) or 19 E1® HXLPE (Zimmer-Biomet). We studied 74 hips except one hip which was revised due to infection at the time of 3 weeks after surgery. Postoperative radiographic evaluations were done at the time of 2, 4, 6, 9, 12 months and then every 6 months thereafter. We examined cancellous condensation, radiolucent line, osteolysis, cortical hypertrophy and stress shielding using both of plain X-ray and Tomosynthesis (Shimadzu, Japan).


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_5 | Pages 55 - 55
1 Apr 2018
Pierrepont J Miller A Bruce W Bare J McMahon S Shimmin A
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Introduction. Appropriate prosthetic alignment is an important factor in maintaining stability and maximising the performance of the bearing after total hip replacement (THR). With a cementless component, the anteversion of the native femur has been shown to influence the anteversion of the prosthetic stem. However, the extent to which anteversion of a cementless stem can be adjusted from the native anteversion has seldom been reported. The aim of this study was to investigate the difference between native and stem anteversion with two different cementless stem designs. Method. 116 patients had 3-dimensional templating as part of their routine planning for THR (Optimized Ortho, Sydney). 96 patients from 3 surgeons (AS, JB, SM) received a blade stem (TriFit TS, Corin, UK) through a posterior approach. 18 patients received a fully HA-coated stem (MetaFix, Corin, UK) through a posterior approach by a single surgeon (WB). The anteversion of the native femoral neck was measured from a 3D reconstruction of the proximal femur. All patients received a post-operative CT scan which was superimposed onto the pre-op CT scan. The difference between native and achieved stem anteversion was then measured. As surgeons had differing philosophies around target stem anteversion, the differences amongst surgeons were also investigated. Results. On average, stems were implanted in less anteversion than native. The mean deviation between native and stem anteversion of the blade stems was −3.5° (−34.8° to 13.8°). The mean deviations of the three surgeons using the blade stem were −7.9° (−34.8° to 10.4°), −3.1° (−18.1° to 12.0°) and 2.7° (−8.9° to 13.8°). These were statistically significant, and represented a difference in philosophy around target anteversion amongst surgeons. The mean deviation between native and stem anteversion of the fully HA-coated stems was −6.5° (−24.6° to 9.2°). Conclusions. Cementless stem anteversion is not dictated by the native femoral anteversion. There were differences in target anteversion philosophies amongst surgeons and this was seen in the results. Surgical approach, proximal entry point, osteotomy angle, stem design and patient anatomy will all influence the ability to dictate cementless stem anteversion. The effect of these variables are the subject of on-going work


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 107 - 107
1 Sep 2012
Boldt J
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Femoral stress shielding in cementless THA is a potential complication commonly observed in cementless distally loading press-fit stems. Long-term metaphyseal fixation and proximal load transfer is desired. Is routine autologous metaphyseal bone impaction and proximal primary stability an answer to this goal?. This prospective study describes long-term femoral bone remodeling and load transfer in cementless THA at a mean of 17 years (range: 15 to 20 years) in 208 consecutive fully HA-coated stems (Corail). All primary THA were performed by one group of surgeons between 1986 and 1991. The concept of surgical technique included impaction of autologous metaphyseal bone using bland femoral broaches until primary stability was achieved without distal press-fit. Radiographic evaluation revealed a total of five (2.4%) stems with periprosthetic osteolysis, which were associated with eccentric polyethylene wear. They were either revised or awaiting revision. The remaining 97.6% stems revealed desired proximal load transfer in the metaphysis (52%) or in both metaphysis and diaphysis (48%). Distal stress shielding was not observed and was considered to be related to: impaction of metaphyseal bone, bland broaches, HA coating, and prosthetic design. Biological autologous bone impaction of the metaphysis provides both primary stem stability and successful longterm osteointegration with the Corail stem after 20 years. The surgical technique of proximal autologous bone impaction rather than extraction of cancellous bone material and the use of a fully HA coated stem without distal press-fit show encouraging longterm results in THA


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 126 - 126
1 Sep 2012
Moroni A Hoque M Micera G Orsini R Nocco E
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Introduction. Metal-on-polycarbonate urethane (MPU) is a cutting-edge new bearing technology for hip arthroplasty. The acetabular component consists of a 2.7mm-thick polycarbonate-urethane liner inserted into a specially manufactured uncemented titanium shell coated with hydroxyapatite [(HA) Fig. 1]. The liner is pliable and biomechanically mimics human cartilage. In vitro studies have shown minimal wear, fluid film lubrication, physiological load transmission and shock absorption capacity equal to the normal hip. This system includes prosthetic heads of a diameter 12mm less than the socket diameter. The aim of this study was to clinically assess patients treated with this novel technology in a retrospective single centre study. Methods. Twenty-seven patients with osteoarthritis treated with MPU bearing arthroplasty were included. Mean patient age was 67.9±10.35 years (44–84). Sixteen patients were female and 11 were male. Twenty-four of these had an uncemented HA-coated stem while 3 had a hip resurfacing metal femoral component. All patients were operated on by a single surgeon using a postero-lateral approach. Results. No patients were lost to follow-up. Mean follow-up time was 29 months (minimum 24 months). There were no major complications. At follow-up, the mean Harris hip score was 98 points (80–99). X-rays showed good bone-implant contact without any osteolysis or bone rarefaction. Discussion and conclusion. Our promising short-term results confirm the in vitro findings. Advantages of this new bearing technology include the possibility to use large diameter metal heads without exposing the patients to elevated levels of metal ions as is the case with metal-on-metal bearings, the minimal wear and the superior biomechanical characteristics