Study protocol: The DUALITY trial—a register-based, randomized controlled trial to investigate dual mobility cups in hip fracture patients

Wolf, Olof; Mukka, Sebastian; Notini, Maja; Möller, Michael; Hailer, Nils P

doi:10.1080/17453674.2020.1780059

Cited by 24 publications

(24 citation statements)

References 39 publications

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“…We believe there is a need for further prospective trials to investigate potentially reduced dislocation rates after the use of DMC, but neither of two ongoing RCTs on the topic of DMC-THA were specifically designed to address the subgroup of patients with neurological disease. 52,53 We believe a radiological review of the HAs with dislocation might also be necessary to identify any predisposing anatomical factors for the dislocation to add to the surgical factors.…”

Section: Discussionmentioning

confidence: 99%

Total, hemi, or dual-mobility arthroplasty for the treatment of femoral neck fractures in patients with neurological disease

Cnudde

Nåtman

Hailer

et al. 2022

The Bone & Joint Journal

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Aims The aim of this study was to investigate the potentially increased risk of dislocation in patients with neurological disease who sustain a femoral neck fracture, as it is unclear whether they should undergo total hip arthroplasty (THA) or hemiarthroplasty (HA). A secondary aim was to investgate whether dual-mobility components confer a reduced risk of dislocation in these patients. Methods We undertook a longitudinal cohort study linking the Swedish Hip Arthroplasty Register with the National Patient Register, including patients with a neurological disease presenting with a femoral neck fracture and treated with HA, a conventional THA (cTHA) with femoral head size of ≤ 32 mm, or a dual-mobility component THA (DMC-THA) between 2005 and 2014. The dislocation rate at one- and three-year revision, reoperation, and mortality rates were recorded. Cox multivariate regression models were fitted to calculate adjusted hazard ratios (HRs). Results A total of 9,638 patients with a neurological disease who also underwent unilateral arthroplasty for a femoral neck fracture were included in the study. The one-year dislocation rate was 3.7% after HA, 8.8% after cTHA < 32 mm), 5.9% after cTHA (= 32 mm), and 2.7% after DMC-THA. A higher risk of dislocation was associated with cTHA (< 32 mm) compared with HA (HR 1.90 (95% confidence interval (CI) 1.26 to 2.86); p = 0.002). There was no difference in the risk of dislocation with DMC-THA (HR 0.68 (95% CI 0.26 to 1.84); p = 0.451) or cTHA (= 32 mm) (HR 1.54 (95% CI 0.94 to 2.51); p = 0.083). There were no differences in the rate of reoperation and revision-free survival between the different types of prosthesis and sizes of femoral head. Conclusion Patients with a neurological disease who sustain a femoral neck fracture have similar rates of dislocation after undergoing HA or DMC-THA. Most patients with a neurological disease are not eligible for THA and should thus undergo HA, whereas those eligible for THA could benefit from a DMC-THA. Cite this article: Bone Joint J 2022;104-B(1):134–141.

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Section: Discussionmentioning

confidence: 99%

Total, hemi, or dual-mobility arthroplasty for the treatment of femoral neck fractures in patients with neurological disease

Cnudde

Nåtman

Hailer

et al. 2022

The Bone & Joint Journal

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“…As the implant can be technically demanding [2] , and its cost-effectiveness has not been determined yet, some restraint or at least reflection is suggested. An ongoing register-based RCT on DMC versus conventional THA will provide more clinical relevant data, including patient-reported outcome [23] . Still, any further palpable improvements in the outcome after a hip fracture will most likely be done elsewhere in the care pathway, and not in design variations of contemporary orthopaedic implants [24] .…”

Section: Discussionmentioning

confidence: 99%

Dual mobility cups do not reduce the revision risk for patients with acute femoral neck fracture: A matched cohort study from the Swedish Arthroplasty Register

Rogmark

Nauclér

2022

Injury

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Introduction: Dual mobility cups (DMC) are gaining in popularity, as a method to reduce the risk of dislocation after fracture-related hip arthroplasty. Our aim was to compare revision rate in general, as well as due to dislocation and infection, after DMC and conventional THA due to femoral neck fracture, for each of the two groups of lateral and posterior approach. Materials and Methods: This observational cohort study based on the Swedish Arthroplasty Register (SAR) compared 2242 patients with dual mobility cups (DMC) and 6726 with conventional total hip arthroplasty (cTHA), all due to acute fracture 2005-2019. This was after propensity score matching of 1:3 (age, gender, ASA). Kaplan-Meier survival analysis was used to investigate the 5-year revision rate after DMC and cTHA in the posterior and lateral approach groups. Results: The rates of revision in general, and due to dislocation or infection, were similar for DMC and cTHA in the different approach groups during the follow-up. The cumulative revision rate after posterior approach was 4.7% (95% CI 3.1-6.2) for DMC and 4.8% (3.8-5.7) for cTHA at 5 years. For lateral approach, the result was 2.3% (CI 1.3-3.3) for DMC and 3.7% (CI 3.0-4.4) for cTHA.The 5-year results for cumulative revision rate due to dislocation after posterior approach were 1.3% (0.4-2.2) for DMC and 2.2% (1.5-2.8) for cTHA. Corresponding results for lateral approach was 0.4% (0-0.8) for DMC and 0.7% (0.4-1) for cTHA. Discussion: With implant revision surgery as outcome, we could not detect any differences between DMC and cTHA. Further studies with high external validity are needed regarding total dislocation rate, patientreported outcome, cost-effectiveness and learning curve, to make a definitive recommendation on the use of DMC for fracture cases. Conclusions: As treatment of acute femoral neck fractures, total hip arthroplasty with a dual mobility cup have similar outcome in terms of revisions in general, and due to dislocation or infections specifically, as one with conventional bearing. The similar outcome is regardless of surgical approach.

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“…48,49 Well-designed prospective randomized studies pertaining to DM-THA use in patients with femoral neck fractures are underway to address these questions. 50,51…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness of dual-mobility components in patients with displaced femoral neck fractures

Montgomery

Bourget-Murray

You

et al. 2021

The Bone & Joint Journal

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Aims Total hip arthroplasty (THA) with dual-mobility components (DM-THA) has been shown to decrease the risk of dislocation in the setting of a displaced neck of femur fracture compared to conventional single-bearing THA (SB-THA). This study assesses if the clinical benefit of a reduced dislocation rate can justify the incremental cost increase of DM-THA compared to SB-THA. Methods Costs and benefits were established for patients aged 75 to 79 years over a five-year time period in the base case from the Canadian Health Payer’s perspective. One-way and probabilistic sensitivity analysis assessed the robustness of the base case model conclusions. Results DM-THA was found to be cost-effective, with an estimated incremental cost-effectiveness ratio (ICER) of CAD $46,556 (£27,074) per quality-adjusted life year (QALY). Sensitivity analysis revealed DM-THA was not cost-effective across all age groups in the first two years. DM-THA becomes cost-effective for those aged under 80 years at time periods from five to 15 years, but was not cost-effective for those aged 80 years and over at any timepoint. To be cost-effective at ten years in the base case, DM-THA must reduce the risk of dislocation compared to SB-THA by at least 62%. Probabilistic sensitivity analysis showed DM-THA was 58% likely to be cost-effective in the base case. Conclusion Treating patients with a displaced femoral neck fracture using DM-THA components may be cost-effective compared to SB-THA in patients aged under 80 years. However, future research will help determine if the modelled rates of adverse events hold true. Surgeons should continue to use clinical judgement and consider individual patients’ physiological age and risk factors for dislocation. Cite this article: Bone Joint J 2021;103-B(12):1783–1790.

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Study protocol: The DUALITY trial—a register-based, randomized controlled trial to investigate dual mobility cups in hip fracture patients

Abstract: Nils P Hailer & the DUALITY GROUP (2020): Study protocol: The DUALITY trial-a register-based, randomized controlled trial to investigate dual mobility cups in hip fracture patients, Acta Orthopaedica,

Cited by 24 publications

References 39 publications

Total, hemi, or dual-mobility arthroplasty for the treatment of femoral neck fractures in patients with neurological disease

Total, hemi, or dual-mobility arthroplasty for the treatment of femoral neck fractures in patients with neurological disease

Dual mobility cups do not reduce the revision risk for patients with acute femoral neck fracture: A matched cohort study from the Swedish Arthroplasty Register

Cost-effectiveness of dual-mobility components in patients with displaced femoral neck fractures

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