| Literature DB >> 34150328 |
Jonathan M R French1, Paul Bramley2, Sean Scattergood1, Nemandra A Sandiford3.
Abstract
Modular dual-mobility (MDM) constructs can be used to reduce dislocation rates after total hip replacement (THR). However, there are concerns about adverse reaction to metal debris (ARMD) as a result of fretting corrosion between the metal liner and shell. This systematic review reports outcomes following THR using MDM components. It was registered with PROSPERO and conducted in line with Cochrane and PRISMA recommendations.Sixteen articles were included overall, with meta-analysis performed on relevant subsets using a random intercept logistic regression model. Estimated median incidence of ARMD requiring revision surgery within study follow-up period was 0.3% (95% CI 0.1 - 1.8%, from 11 cohort studies containing 1312 cases).Serum metal ion levels were mildly raised in 7.9% of cases, and significantly raised in 1.8%, but there was no correlation with worse clinical hip function scores within studies. Dislocation rate was 0.8%. Revision rate was 3.3%.There are mixed reports of wear on the backside of the metal liner from the acetabular shell and screw heads. Both implant design and component malseating are implicated, but currently it is unclear to what extent each factor is responsible.Studies were poor quality with high risk of confounding, especially from trunnion corrosion. We have made recommendations for further work. In the meantime, surgeons should be aware of the potential risk of ARMD when considering using an MDM prosthesis, and, if selecting one, must ensure proper seating of the liner and screws intraoperatively. Cite this article: EFORT Open Rev 2021;6:343-353. DOI: 10.1302/2058-5241.6.200146.Entities:
Keywords: ALTR; ARMD; arthroplasty; hip replacement; metal; modular dual-mobility
Year: 2021 PMID: 34150328 PMCID: PMC8183148 DOI: 10.1302/2058-5241.6.200146
Source DB: PubMed Journal: EFORT Open Rev ISSN: 2058-5241
Healthcare Databases Advanced Search (HDAS) strategy
Fig. 1Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram outlining the systematic review process.[32]
Summary of all study characteristics, grouped by study type. A dash (–) denotes data that were unreported. An asterisk (*) denotes data excluded from meta-analysis, e.g. case series are unable to contribute data on incidence
| Study | Study design (single centre unless specified) | Primary or revision THR | Number of cases | Average follow-up (years) | Implant (company) | Mean age (years) | Mean BMI (kg/m^2) | Dislocations, | Revisions, | ARMD, | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| With serum metal ion measurements | Civinini et al, 2020[ | Cross-sectional study | Revision | 37 | 5.1 | Delta TT System (Lima) | 63.7 | 26.5 | – | – | 0 |
| Markel et al, 2019[ | Prospective cohort, non-comparative | Primary | 39 | 2 | MDM (Stryker) | 61.7 | 28.4 | – | – | 0 | |
| Chalmers et al, 2019[ | Prospective cohort, non-comparative | Both | 24 | 4 | MDM (Stryker) | 63.0 | 31.0 | – | Excluded | 0 | |
| Nam et al, 2019[ | Prospective cohort, non-comparative | Primary | 43 | 2 | MDM (Stryker) | 52.6 | 27.9 | – | 0 | 0 | |
| Diamond et al, 2018[ | Retrospective cohort, non-comparative | Revision | 60 | 3.21 | MDM (Stryker) | 65.5 | 30.9 | – | 6 (10%) | 2 (3.3%) | |
| Barlow et al, 2017[ | Prospective case-series of various well functioning primary THRs | Primary | 20 | 1.3 | MDM (Stryker) | 66.8 | – | Excluded | Excluded | Excluded | |
| Matsen Ko et al, 2016[ | Retrospective cohort, non-comparative | Primary | 100 | 2.3 | MDM (Stryker) | – | – | 1 | 0 | 2 | |
| Without serum metal ion measurements | Dubin et al, 2019[ | Retrospective cohort: MDM vs. ADM | Primary | 287 | 2.86 | MDM (Stryker) | 67.9 | 29.3 | 0 | 5 (1.7%) | 0 |
| Li et al, 2019[ | Retrospective cohort: MDM vs. conventional | Revision | 94 | 3.15 | MDM (Stryker) | 63.6 | 29.6 | 2 (2.13%) | 9 (9.57%) | 1 (1%) | |
| Huang et al, 2019[ | Retrospective cohort, multi-centre, non-comparative | Revision | 315 | 3.3 | MDM (Stryker) | 65.8 | 31.4 | 9 (3.8%) | 30 (9.5%) | 0 | |
| Sutter et al, 2017[ | Retrospective cohort, non-comparative | Revision | 64 | 3.17 | MDM (Stryker) | 59.0 | 29.4 | 2 (3.1%) | 18.80% | 1 (1.6%) | |
| Harwin et al, 2017[ | Retrospective cohort, multi-centre, non-comparative | Primary | 249 | 3.3 | MDM (Stryker) | 66.0 | 34.0 | 0 | 2 (0.8%) | 0 | |
| Implant retrieval analyses | Kolz et al, 2020[ | Implant retrieval case series: MDM | Both | 12 | 2.16 | MDM (Stryker) | – | 26.0 | N/A | N/A | * |
| Lombardo et al, 2019[ | Implant retrieval analysis: ADM vs. MDM | – | 18 | 1.12 | MDM (Stryker) | 70.5 | 30.0 | N/A | N/A | * | |
| Tarity et al, 2017[ | Implant retrieval analysis: MDM vs. MoM | Both | 18 | 1.25 | MDM (Stryker) | 64.0 | 27.0 | N/A | N/A | * | |
| Radiological | Romero et al, 2020[ | Retrospective cohort: MDM | Primary | 551 | – | MDM (Stryker) | 67.9 | 28.3 | – | – | – |
Notes. THR, total hip replacement; BMI, body mass index; ARMD, adverse reaction to metal debris; MDM, modular dual-mobility; ADM, ‘anatomical’ dual-mobility; MoM, metal-on-metal.
Fig. 2Forest plot showing adverse reaction to metal debris (ARMD) incidence.
Appendix 2.All other forest and funnel plots from meta-analysis
Serum metal ion levels by study, with relevant characteristics such as femoral head material and use of acetabular screws. An asterisk (*) is used to indicate where individual data were not specified, necessitating a conservative estimate (see Methods)
| Study | Primary or revision THR | Number | Implant | Femoral head material | Acetabular screw fixation | ARMD, | Average serum metal ion levels (μg/L), mean unless specified | Number of cases with Co or Cr ≥ 1 μg/L | Number of cases with Co or Cr ≥ 7 μg/L |
|---|---|---|---|---|---|---|---|---|---|
| Civinini et al, 2020[ | Revision | 37 | Delta TT System (Lima) | CoCr | All pts (mean 4.2 screws, range 2–7) | 0 | Co 1.99 (95% CI 0.81–3.17, range 0.07–16.05), Cr 2.08 (95% CI 0.9–3.2, range 0.02–11.8) | 11 (29.7%) | 2* |
| Markel et al, 2019[ | Primary | 39 | MDM (Stryker) | Ceramic | – | 0 | Co 0.63 ( | 4 (10.3%) | 0 |
| Chalmers et al, 2019[ | Both | 24 | MDM (Stryker) | Ceramic | All patients | 0 | Co 0.3 (range 0.2–0.6), Cr 0.76 (0.1–12.0) | 1 (4.2%) | 1 (4.2%) |
| Nam et al, 2019[ | Primary | 43 | MDM (Stryker) | 14 CoCr, 29 ceramic | – | 0 | Co 0.16 ( | 0 | 0 |
| Diamond et al, 2018[ | Revision | 60 | MDM (Stryker) | 59 CoCr, 1 ceramic | ‘Most commonly, 2 or 3’ | 2 (3.3%), both recurrent | Median Co 0.42 (range 0.21–9.42), Cr 0.4 (range 0.1–6.1) | 2* (3.3%) | 1 (1.7%) |
| Barlow et al, 2017[ | Primary | 20 | MDM (Stryker) | 10 CoCr, 10 ceramic | – | 0 | Co 0.85 ( | 1* (5%) | 0 |
| Matsen Ko et al, 2016[ | Primary | 100 | MDM (Stryker) | 99 CoCr, 1 ceramic | – | 2 | ‘Average’ Co 0.7 (range 0.0–7.0), Cr 0.6 (range 0.1–2.7) | 9 (9%) | 1 (1.0%) |
Notes. THR, total hip replacement; ARMD, adverse reaction to metal debris; Co, cobalt; Cr, chromium; MDM, modular dual-mobility.
Table showing individual risk of bias (MINORS) scores
| MINORS 1 | MINORS 2 | MINORS 3 | MINORS 4 | MINORS 5 | MINORS 6 | MINORS 7 | MINORS 8 | MINORS 9 | MINORS 10 | MINORS 11 | MINORS 12 | Total | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Kolz et al, 2020 | 2 | 1 | 2 | 2 | 0 | 1 | 0 | 0 | 8 | ||||
| Romero, 2020 | 2 | 2 | 2 | 2 | 0 | 2 | 0 | 0 | 10 | ||||
| Civinini et al, 2020 | 2 | 2 | 1 | 2 | 0 | 2 | 1 | 0 | 10 | ||||
| Dubin et al, 2019 | 2 | 1 | 2 | 2 | 0 | 1 | 1 | 0 | 2 | 2 | 2 | 2 | 17 |
| Li et al, 2019 | 2 | 2 | 2 | 2 | 0 | 1 | 0 | 1 | 2 | 2 | 1 | 2 | 17 |
| Markel et al, 2019 | 2 | 0 | 2 | 2 | 0 | 1 | 0 | 0 | 7 | ||||
| Chalmers et al, 2019 | 1 | 2 | 2 | 2 | 0 | 1 | 1 | 0 | 9 | ||||
| Huang et al, 2019 | 2 | 0 | 2 | 2 | 0 | 1 | 0 | 0 | 7 | ||||
| Nam et al, 2019 | 2 | 0 | 2 | 2 | 0 | 1 | 0 | 2 | 9 | ||||
| Lombardo et al, 2019 | 1 | 0 | 2 | 2 | 0 | 1 | 0 | 0 | 2 | 0 | 1 | 2 | 11 |
| Diamond et al, 2018 | 1 | 2 | 0 | 1 | 0 | 1 | 0 | 0 | 5 | ||||
| Sutter et al, 2017 | 1 | 2 | 0 | 2 | 0 | 1 | 0 | 0 | 6 | ||||
| Harwin et al, 2017 | 2 | 0 | 1 | 2 | 0 | 1 | 1 | 0 | 7 | ||||
| Tarity et al, 2017 | 2 | 1 | 2 | 2 | 0 | 1 | 0 | 0 | 1 | 2 | 1 | 2 | 14 |
| Barlow et al, 2017 | 2 | 1 | 1 | 2 | 0 | 1 | 0 | 0 | 1 | 2 | 1 | 2 | 13 |
| Matsen Ko et al, 2016 | 1 | 2 | 1 | 1 | 0 | 1 | 2 | 0 | 8 |
Fig. 3Photograph showing fretting on the backside of the modular metal liner from acetabular screw heads.
Source: Reproduced with the authors’ permission, courtesy of Lombardo et al.[29]