The use of Dual Mobility cups in primary Total Hip Arthroplasty: a bicentric, retrospective study of 196 implants

doi:10.21203/rs.3.rs-2476540/v1

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The use of Dual Mobility cups in primary Total Hip Arthroplasty: a bicentric, retrospective study of 196 implants

https://doi.org/10.21203/rs.3.rs-2476540/v1

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Background

Dual Mobility is based on two concentric joints: a head within a retentive polyethylene liner, which moves freely inside the acetabular cup. This paper aims to present our experience with the use of dual mobility in primary hip replacement, evaluating the patient’s outcome after surgery.

Methods

We conducted a retrospective bi-centre study, including all patients operated with a dual mobility hip replacement at “Centro Medico de Caracas” (Caracas, Venezuela) and “Guglielmo da Saliceto Hospital” (Piacenza, Italy), between August 2014 and August 2020 (6 years). Dualis® dual mobility cementless cup was used in all surgeries, coupled with different stems. Outcome assessment after hip replacements was determined with the Harris Hip Score at 3 months post surgery., then we registered any complications in the first two postoperative years.

Results

The total cohort was composed of 196 THAs: 35.4% male, 64.6% female (64.6%), mean age 63.6 years. We used 3 different stems: Korus (Gruppo Bioimpianti S.r.l.) (78.1%), Fin (Gruppo Bioimpianti S.r.l.) (3.1%) and Corail (DePuy Synthes) (18.9%). The femoral head was composed of ceramic (93.9%) or metal (6.1%); the size was always 28 mm. The average Harris Hip Score was 34.3 ± 15.8 (min 4 - max 69) preoperative, and 91.2 ± 6.7 (min 61 - max 100) at 3 months follow-up. The HHS grading was “Poor” in 1.0% cases, “Fair” in 6.1% cases, “Good” in 27.0% cases and “Excellent” in 65.8% cases. The outcome was significantly better in young patients: mean HHS of the 98 younger patients is 95.9 ± 2.8, while that of the 98 older patients is 86.5 ± 6.2 (p value < 0.001). We registered an overall dislocation rate of 0%, while we reported 8 revisions (4.1%), due to periprosthetic fracture (4), aseptic loosening (1, infection (1), component breakage (1) and pain (1). The coupling Dualis-Korus reported a failure rate of 3.3% (5/153), Dualis-Fin 16.7% (1/6) while Dualis-Corail 5.4% (2/37).

Conclusion

The dual mobility system is an effective solution within primary hip replacement: it reduces wear and loosening forces, increasing joint range and prosthesis stability, with a very low incidence of dislocation. In younger patients, and arthritic ones, even the best results can be expected.

Dual mobility

Total hip arthroplasty

Outcomes

Total Hip Replacement (THR) is recognized as one of the greatest successes in orthopaedic surgery worldwide [1]. The objectives to be achieved in all hip replacements are: to provide total or at least partial pain relief, achieve good stability, and permit a wide range of motion (ROM) with minimal wear.

In the pursuit of these objectives, there are several elements involved in the historical evolution of said surgical procedure, such as the design of the implants, their component materials, friction pairings, wear and surgical implantation techniques [2–4]. Given both the improvement in life expectancy and the increase in functional demands of the elderly population, we are witnessing significant boosts in joint replacements and the figures are likely to continue to increase with time [5].

Post-surgical complications will always be feared by surgeons, despite the significant decrease in their incidence compared to the past. The main ones are infectious processes, dislocations, neurological sequelae, vascular lesions, leg length discrepancies, periprosthetic fractures, heterotopic ossification and periprosthetic osteolysis with loosening.

The prevalence of hip dislocation following primary arthroplasty varies between 0.2% and 10%, representing also the most common cause of revision hip surgery [6,7]. This complication generally occurs in the first months after surgery, and we could even divide dislocations according to their time of onset into early (less than 3 months) and late (more than 3 months). Most authors report that the incidence of early dislocation is more frequent [8–10]. Moreover, the direct lateral approach seems to be associated with a higher rate of revision for dislocation if compared with the anterior approach, while the posteriolateral approach is the one with the greatest risk [11].

The list of risk factors for hip replacement dislocation is extensive and principally includes patient-related factors (such as gender, age, diagnosis, previous surgeries, neuromuscular dysfunction, non-compliance with prophylactic anti-dislocation guidelines, cognitive dysfunction, alcohol and drug abuse), surgery-related factors (such as approach, component orientation, soft tissue tension, surgeon’s experience and perioperative infection) and implant-related factors (such as femoral head size, head-to-acetabulum size ratio and acetabular component design) [12,13].

In France, Gilles Bousquet and Andrè Rambert developed the concept of Dual Mobility (DM), creating the so-called Dual Mobility Cup [14]. This component consists of two concentric joints: a prosthetic head (22 or 28 mm) within a retentive polyethylene liner, which moves freely inside a highly polished metal acetabular cup [15]. The diameter of the large head is usually 6 to 8 mm smaller than the size of the outer shell of the cup. Most of the movement occurs at the head-liner interface. A third joint is described, which is made up of the neck and polyethylene head [16].

This paper aims to present our experience with the use of the dual mobility system in primary THR (pTHR). The primary endpoint is to evaluate the patient’s outcome after DM THA, assessed during the first 3 months post-surgery by both a clinical visit and the calculation of the Harris Hip Score (HHS) [17]. The pre-operative HHS was registered and assessed in all the medical records reviewed.

We conducted a retrospective bi-centre study, including all patients operated with a DM THA at “Centro Medico de Caracas” (Caracas, Venezuela) and “Guglielmo da Saliceto Hospital” (Piacenza, Italy). We considered the period between August 2014 and August 2020 (6 years). Obviously, the spread of the Covid-19 pandemic throughout the world has influenced the data of the last few years, in which we have recorded a decrease in the procedures performed in both Centres [18,19].

The inclusion criteria were patients with symptoms, clinical evaluation and radiological imaging compatible with severe hip osteoarthritis (Fig. 1,2); aged between 40 and 99 years; causes of arthritis attributable to primary osteoarthritis, Developmental Dysplasia of the Hip (DDH), AVascular Necrosis of the femoral head (AVN), outcomes of femoral neck’s fracture; preoperative evaluation of the patient through the HHS.

All surgeries in both Centres were performed using the direct lateral approach according to Hardinge, implanting a THA with a Dualis® DM cup (Dualis System® Gruppo Bioimpianti S.r.l., Milano, Italy) (Fig. 3,4). All cups included in the cohort were cementless. DM cups were coupled with several stems from different Companies: Korus (Gruppo Bioimpianti S.r.l., Milano, Italy), Fin (Gruppo Bioimpianti S.r.l., Milano, Italy), and Corail (DePuy Synthes, Warsaw, IN, USA).

During the immediate postoperative period, a control pelvis X-ray was requested where the position of the prosthetic components was evaluated. The patients received pain management therapy, which allowed the immediate start of physiotherapy exercises the day after surgery to restore the entire ROM [20]. Using a walker or crutches, they started walking on the first or, at the latest, second postoperative day, with partial and progressive weight bearing according to patient tolerance, except for those who had intraoperative complications.

We analysed the medical records of the selected patients, looking for information related to surgery (type of implant, fixation method, surgical approach, intraoperative complications), hospitalisation (length of stay, blood transfusion), and postoperative course (thrombosis, pulmonary embolism, haematomas, nerve injury, anaemia, and complications inherent to the operative wound).

Outcome assessment after hip replacements was determined with the HHS (administered 3 months after surgery), and the occurrence of any complications in the first two postoperative years.

After being discharged from the ward, patients were evaluated weekly during the first month to check the operative wound and patients’ advances in ROM and pain control. Subsequently, a follow-up (FU) evaluation was carried out postoperatively at 1–3–6–12 and 24 months after surgery. The patients who did not comply with the last consultation were contacted by telephone and then searched for any major complications. Patients who did not complete this FU evaluation or died before the end of the FU were excluded from the study.

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Statistical analysis

Continuous variables were expressed by the mean and standard deviation (SD) and were evaluated by Student T-test or Mann-Whitney U test. The categorical data were expressed as number and percentage (%) and were evaluated by chi-square or Fisher’s exact test. The statistical test level was set as p < 0.05. SPSS, version 23.0, was used to perform all the tests (IBM, Armonk, NY, USA).

During the examined period, 213 patients were operated with a DM THA. According to the inclusion/exclusion criteria, the total cohort was composed of 196 THAs and 189 patients (7 of the patients had a bilateral hip replacement); 67 were male (35.4%), while 122 were female (64.6%). The mean age at the time of surgery was 63.6 years ± 7.3, the median was 66 years. About components, we used only Dualis cementless cups (Gruppo Bioimpianti S.r.l., Milano, Italy) (Fig. 3,4), while the femoral stem was cemented in 7 cases (3.6%) and cementless in the other 189 (96.4%). Analyzing the femoral components, we used Korus stem (Gruppo Bioimpianti S.r.l., Milano, Italy) in 153 cases (78.1%), Fin stem (Gruppo Bioimpianti S.r.l., Milano, Italy) in 6 cases (3.1%) and Corail stem (DePuy Synthes, Warsaw, IN, USA) in 37 cases (18.9%). On the other hand, the femoral head was composed of ceramic in 184 cases (93.9%) and metal in 12 cases (6.1%); the size of all the implanted heads was 28 mm.

The HHS applied to each patient before surgery yielded an initial value that in all cases was “Poor”, with an average score of 34.3 ± 15.8 (min 4 - max 69).

In 3 of the patients (1.5% of all procedures), an incomplete fracture of the medial cortex of the femoral shaft was reported during the surgery, but resolved without major complications. Weight-bearing support was deferred for 3 weeks with the subsequent incorporation of progressive weight bearing until full recovery and incorporation of walking without support. The other cases did not report intraoperative complications and it was possible to start physiotherapy on the first postoperative day.

The average hospital stay was 5.9 ± 2.4 days (min 2 - max 9). During the immediate postoperative period, 63 patients (32.1%) required a red blood cell transfusion due to a decrease in the haemoglobin level. Any neurological or vascular complication was not registered. 5 patients (2.6%) showed an organised haematoma, that did not require surgical drainage; 3 (1.5%) wound dehiscences and 2 (1.0%) pulmonary embolisms were recorded; 1 patient (0.5%) underwent second surgery one week post-operatively due to dehiscence of the fascia lata suture, resulting in no complications; finally, a superficial infection of the wound was ruled out, but conservative treatment with targeted antibiotic therapies was sufficient to treat it and in any cases no surgery was necessary.

When the HHS test was applied during the late postoperative period, at the 3 months outpatient visit, the score always rose to a value higher than the starting one, with a mean growth of 56.9 points (min 35 - max 82). The average HHS was 91.2 ± 6.7 (min 61 - max 100). The HHS grading was “Poor” for 2 patients (1.0%), “Fair” for 12 patients (6.1%), “Good” for 53 patients (27.0%) and “Excellent” for 129 patients (65.8%).

If we focus only on the 164 patients operated for osteoarthritis (86.2% of the total cohort), the average HHS values increase to an average of 93.2 ± 4.6 (min. 77 - max 100) (Fig. 2). Within this subgroup, the HHS grading was “Fair” for 3 (1.8%), “Good” for 31 (18.9%) and “Excellent” for 130 (79.3%). “Poor” for none patient.

Using the median age of the cohort, we divided our patients into two equal halves to evaluate the difference outcome based on age. We stated that it was significantly better in young patients (p value < 0.001). In fact, the mean HHS of the 98 younger patients is 95.9 ± 2.8, while that of the 98 older patients is 86.5 ± 6.2.

Radiographic analysis revealed a mean acetabular tilt of 49° (range 31–65°). There were no osteolysis or radiolucent lines around the acetabular component of the whole cohort during the 2 years FU period. Moreover, at the end of the FU no complications or revisions due to dislocation or instability were recorded, with an overall dislocation rate of 0%. On the other hand we reported 8 revisions (4.1%): the main cause was periprosthetic fracture (4 cases, 2.0% of total THAs, 50.0% of revision surgeries), followed by aseptic loosening (1 case, 0.5% of total THAs, 12.5% of revision surgeries), infection (1 case), component breakage (1 case) and pain (1 case). In 3 cases (37.5%) the failure of the prosthesis occurred in the first 3 months, in 2 cases (25.0%) it occurred between 4 and 12 months, while in the remaining 3 cases (37.5%) it occurred after the first year. Failure of a Dualis-Korus fit prosthesis occurred 5 times (62.5%), 1 time (12.5%) for Dualis-Fin and 2 times (25.0%) for Dualis-Corail fit. Consequently, the coupling Dualis-Korus reported a failure rate of 3.3% (5/153), Dualis-Fin of 16.7% (1/6) while Dualis-Corail of 5.4% (2/37).

The DM design embraces the following concepts: low friction and minimal Charnley wear, a large head to restore anatomy and increase stability proposed by McKee and Farrar, meaning that this design includes a joint that minimises wear issues and a large joint to prevent instability [21]. In fact, with the increase in the "head to neck ratio" the "jump distance" will also rise, thus reducing the risk of dislocation.

The objectives of this design are to reduce wear and loosening forces, to use a physiological system and to increase joint range without compromising intra-prosthetic stability [21,22].

A review of comparative results, where the main parameter to be evaluated is stability, showed that dual mobility cups have excellent short and medium term results compared to standard implants in pTHR [22]. In a prospective cohort study of 143 dual mobility versus 130 standard implants at 4-year FU, Epinette established a statistically significant difference in the dislocation rate in favour of dual mobility (0% vs. 5.4%) [23]; in all cases, the same stem and a cementless cup were fitted with a 28 mm head; there were no cases of mechanical cup loosening in any of the cohorts. Similarly, in a case-control study comparing 105 dual mobility and 215 standard prostheses with a 22 mm head in pTHR, Caton et al. observed a statistically significant difference in both the dislocation rate (0.9% versus 12.9% respectively) and the revision rate (2.1% versus 12.9% respectively) at 10-year [24]. Prudhon et al. found no significant differences in aseptic loosening, infection, or periprosthetic fracture between the two cohorts. The main significant difference was the higher revision rate due to dislocation on the standard bearing cups (17.7%) when compared to dual mobility (4.7%) [25].

Most of the literature on DM is based in France, where its use is more common. In fact, from January 1st 2006 to December 31st 2019, for a total of 45397 primary THAs, in 39.3% of cases, a DM cup was implanted [26]. Data on DM from other global national registers is more limited, even if we are witnessing a progressive increase in its use, as recently stated by the American Joint Replacement Registry (AJRR). Actually, the 2021 AJRR Annual Report reported a statistically significant increase in the use of DM cups for elective pTHR when comparing 2012 to 2020, especially in young patients (< 50 years) [27]. In addition, encouraging early results have emerged from some European national joint registries: comparing 620 dual mobility prostheses with 2,170 standard cemented cups with a 28 mm head in the “Lithuanian Arthroplasty Register”, the 5-year cumulative revision rate was 3.9% in the dual mobility group and 5.2% in the cemented standard prosthesis group [28]. In addition, in the “Dutch Arthroplasty Register”, analysis of 3,038 dual mobility and 212,915 standard hip replacements showed that 0.2% of hip replacements with dual mobility prostheses underwent a revision for dislocation at 5-year FU compared to 0.5% in the standard primary prostheses group [29]. Our cohort, even if limited in number, seems to confirm the very low dislocation rate of dual mobility THA, since after 2 years follow-up we did not recorded even one.

The results of contemporary DM THA have been even more interesting in high-risk patient populations, such as obese patients (defined as a BMI greater than 30 kg/m2). Hernigou et al. reported a statistically significant difference between obese patients who underwent a pTHR: at 7-year FU the dislocation rate of THAs with DM (or constrained liners) was 2%, whereas that of THAs with standard cups was 9% [30]. Furthermore, the use of DM was more effective than preoperative bariatric surgery in reducing the risk of dislocation (dislocation rate of 14% at 7-year FU) [30]. Patients with cerebral palsy or other neurological diseases are also at high risk of instability after THR. This is likely to be secondary to persistent coxa valga, increased femoral anteversion, and associated unbalanced forces generated by the adductor, internal rotator and hip flexor muscles. The review published by Raphael et al. about the use of THR with standard support in patients with cerebral palsy showed a dislocation rate of 14% with a mean FU of 9.7 years [31]. Subsequently, DM was used with promising short-term results: Sanders et al. reported no dislocations in dual mobility hip joint replacements for patients with cerebral palsy at a mean FU of 39 months [32]. Similarly, Morin et al. report that there were no aseptic loosening or dislocations in dual mobility THR performed in 40 patients with cerebral palsy at a mean FU of 5 years [33].

Dislocation represents one of the most insidious and feared complications for neurological patients [34]. Within our cohort, there were 4 patients with neurological disease; 3 of them suffered from Parkinson’s disease, while 1 had a diagnosis of multiple sclerosis. Despite this issue, we have not reported cases of dislocation within our cohort. Moreover, these patients score lower both on preoperative and postoperative HHS, however reporting a substantial improvement in the score.

Several studies testified to the greater risk of postoperative instability among THRs for femoral fracture compared to those implanted for other causes [36–38]. This could be secondary to a combination of muscle failure and a propensity for recurrent falls, representing a life-threatening complication [38]. Consequently, several centres started to employ DM system THAs for femoral neck fractures, with promising initial results. In a population of 105 patients, Tarasevicius et al. reported a statistically significant reduction in the dislocation rate of dual mobility THAs (0/42) compared to standard cups (8/56) during the first postoperative year [39]. Similarly, in a prospective multicentre study of 214 femoral neck fractures treated with DM THAs, Adam et al. reported a dislocation rate of only 1.4% at 9-month FU with 70% of patients returning home without increased dependency [40].

Dual mobility hip replacements have also performed favourably compared to hemiarthroplasty (HA). Bensen et al. retrospectively compared 171 bipolar HAs with 175 dual mobility arthroplasties performed in patients with displaced femoral neck fractures [41]. There was a statistically significant difference in the rate of dislocation, with an incidence of 14.6% among bipolar HAs and of 4.6% for DM arthroplasties [41]. Patient outcome studies are also promising: in the cross-sectional study by Tabori-Jensen et al. 89% of the 124 patients with dual mobility arthroplasties after a femoral neck fracture were satisfied with their surgical outcome, using health-related quality of life questionnaires comparable to the population norm with a mean FU of 2.8 years [42].

In a few cases, we have not achieved a clear improvement in the HHS score, or in any case, an improvement not comparable to the other subjects of the cohort. This was especially due to other osteoarticular pathologies that several patients were suffering from, such as severe osteoarthritis of the contralateral hip or knee osteoarthritis. Whereby, despite having a hip replacement and greatly improving their quality of life, hip replacement alone did not lead to complete resolution of the patients' pain and disability, and they remain with an assisted gait or were unable to walk for a prolonged time, or perform other activities such as walking up and down the stairs unassisted. Therefore we are expecting to achieve lower postoperative HHS in these patients when compared to patients who prior to surgery only suffer from osteoarthritis.

We found that younger patients achieve better results in their postoperative outcome. This issue is not surprising and indeed goes to support what previous studies had already underlined [43,44].

In the study there are two important limitation: the small number of patient and the surgical approach. All the prostheses included in the cohort were implanted with the direct lateral approach of Hardinge. Previous studies have shown that this surgical approach is less prone to postoperative dislocations than others: the posterolateral approach, with or without re-attachment of the short external rotators and/or the posterior joint capsule, is characterized by a higher dislocation rate [11,45].

The results of this study allow us to conclude that the DM design implant is an effective solution within primary THA. The objectives sought with the dual mobility system are based on reducing wear and loosening forces, increasing joint range of movement and prosthesis stability. Consequently, this prosthetic design succeeds in providing provides excellent results, with a very low incidence of dislocation. In younger patients, and arthritic ones, even the best results can be expected.

Total Hip Replacement (THR)

range of motion (ROM)

Dual Mobility (DM)

Primary Total Hip Replacement (pTHR)

Harris Hip Score (HHS)

Developmental Dysplasia of the Hip (DDH)

AVascular Necrosis (AVN)

Follow-up (FU)

Standard Deviation (SD)

American Joint Replacement Registry (AJRR)

Hemiarthroplasty (HA)

Ethics approval and consent to participate: Ethical approval was waived since this was an anonymized observational retrospective study. However, the informed consent to participate in the study was obtained from the patient, associated to the agreement to publish all the necessary information.

Consent for publication: not applicable

Availability of data and materials: not applicable

Competing interests: not applicable

Funding: Support for the publication of this study has been given from Gruppo Bioimpianti S.r.l.

Authors' contributions: conceptualization, C.C. and F.Q.; methodology, C.C. F.Q. and G.C.; writing-original draft preparation, C.C. and F.Q:; review and editing, C.C., F.Q. and G.C.; visualization, C.C. and F.Q.; supervision, P.M.. All authors have read and agreed to the published version of the manuscript.

Acknowledgements: not applicable

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No competing interests reported.

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The use of Dual Mobility cups in primary Total Hip Arthroplasty: a bicentric, retrospective study of 196 implants

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