A Prospective Randomized Controlled Trial of Dual-Mobility Components in Primary THA
NCT ID: NCT03371212
Last Updated: 2026-01-08
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
52 participants
INTERVENTIONAL
2017-12-15
2036-12-01
Brief Summary
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Detailed Description
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Initial dual mobility designs consisted of a cementless, monoblock acetabular component with a highly-polished metal inner bearing surface. Modular dual mobility prostheses have been introduced in which a modular cobalt-alloy liner is inserted into a hemispherical titanium acetabular component. Advantages of this construct include familiarity of use of a standard titanium acetabular component and the ability to use supplemental screw fixation. However, the potential for fretting corrosion between the cobalt-alloy liner and the titanium acetabular component remains a concern.
In a retrospective review of 100 consecutive patients undergoing primary THA using a modular dual mobility prosthesis, the authors found 21% of patients to have a serum cobalt level above the normal range, with 9% significantly above normal (\> 1.6 ug/L), at a mean of 27.6 months postoperatively. In addition, a recent prospective cohort study of 26 patients receiving the same prosthesis showed elevated whole blood mean cobalt levels in patients receiving a modular dual mobility prosthesis versus patients receiving a conventional bearing (0.23 + 0.39 vs. 0.15 + 0.07ug/L, p\<0.001) at 1 year postoperatively. Four patients in the dual mobility cohort had a whole blood cobalt level outside the reference range (maximum 1.81 ug/L).
To the investigators knowledge no prospective, randomized controlled trial has been performed comparing dual mobility bearings to a conventional single-bearing design. Therefore, the purpose of this study is to compare the use of a conventional single-bearing ceramic-on-polyethylene surface to use of a modular dual mobility bearing in a prospective, randomized controlled setting.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Conventional Cohort
Patients in this group will receive a Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components \> 52mm), polyethylene bearing, and G7 acetabular shell.
Conventional cohort
Patients will receive a Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components \> 52mm), polyethylene bearing, and G7 acetabular shell
Modular Dual Mobility Cohort
Patients in this group will receive a Taperloc femoral stem, inner ceramic femoral head (28mm), mobile polyethylene bearing, cobalt alloy liner, and G7 acetabular shell.
Dual mobility cohort
Patients will receive the Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components \> 52mm), polyethylene bearing, and G7 acetabular shell.
Interventions
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Dual mobility cohort
Patients will receive the Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components \> 52mm), polyethylene bearing, and G7 acetabular shell.
Conventional cohort
Patients will receive a Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components \> 52mm), polyethylene bearing, and G7 acetabular shell
Eligibility Criteria
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Inclusion Criteria
* Willingness to undergo serial postoperative venipuncture for serum meal analysis
* BMI \< 40
* Patients that are eligible for the requisite implants as deemed by their surgeon
Exclusion Criteria
* Diminished renal function
* Presence of any metal-containing implant outside of the oral cavity
* History of prior hip surgery involving an internal fixation device
* History of hip infection
* Preoperative diagnosis other than osteoarthritis
* Anticipated need for another joint replacement surgery within one year
* Patients taking chromium supplements
18 Years
80 Years
ALL
No
Sponsors
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Rush University Medical Center
OTHER
Zimmer Biomet
INDUSTRY
Responsible Party
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Locations
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Rush University Medical Center
Chicago, Illinois, United States
Countries
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References
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Patel PD, Potts A, Froimson MI. The dislocating hip arthroplasty: prevention and treatment. J Arthroplasty. 2007 Jun;22(4 Suppl 1):86-90. doi: 10.1016/j.arth.2006.12.111.
Berry DJ. Unstable total hip arthroplasty: detailed overview. Instr Course Lect. 2001;50:265-74.
Nam D, Salih R, Brown KM, Nunley RM, Barrack RL. Metal Ion Levels in Young, Active Patients Receiving a Modular, Dual Mobility Total Hip Arthroplasty. J Arthroplasty. 2017 May;32(5):1581-1585. doi: 10.1016/j.arth.2016.12.012. Epub 2016 Dec 21.
Haughom BD, Plummer DR, Moric M, Della Valle CJ. Is There a Benefit to Head Size Greater Than 36 mm in Total Hip Arthroplasty? J Arthroplasty. 2016 Jan;31(1):152-5. doi: 10.1016/j.arth.2015.08.011. Epub 2015 Aug 14.
Matsen Ko LJ, Pollag KE, Yoo JY, Sharkey PF. Serum Metal Ion Levels Following Total Hip Arthroplasty With Modular Dual Mobility Components. J Arthroplasty. 2016 Jan;31(1):186-9. doi: 10.1016/j.arth.2015.07.035. Epub 2015 Jul 23.
Heffernan C, Banerjee S, Nevelos J, Macintyre J, Issa K, Markel DC, Mont MA. Does dual-mobility cup geometry affect posterior horizontal dislocation distance? Clin Orthop Relat Res. 2014 May;472(5):1535-44. doi: 10.1007/s11999-014-3469-1. Epub 2014 Jan 24.
Langlais FL, Ropars M, Gaucher F, Musset T, Chaix O. Dual mobility cemented cups have low dislocation rates in THA revisions. Clin Orthop Relat Res. 2008 Feb;466(2):389-95. doi: 10.1007/s11999-007-0047-9. Epub 2008 Jan 10.
Loving L, Lee RK, Herrera L, Essner AP, Nevelos JE. Wear performance evaluation of a contemporary dual mobility hip bearing using multiple hip simulator testing conditions. J Arthroplasty. 2013 Jun;28(6):1041-6. doi: 10.1016/j.arth.2012.09.011. Epub 2013 Feb 22.
Civinini R, Carulli C, Matassi F, Nistri L, Innocenti M. A dual-mobility cup reduces risk of dislocation in isolated acetabular revisions. Clin Orthop Relat Res. 2012 Dec;470(12):3542-8. doi: 10.1007/s11999-012-2428-y. Epub 2012 Jun 15.
Hamadouche M, Arnould H, Bouxin B. Is a cementless dual mobility socket in primary THA a reasonable option? Clin Orthop Relat Res. 2012 Nov;470(11):3048-53. doi: 10.1007/s11999-012-2395-3.
Epinette JA, Beracassat R, Tracol P, Pagazani G, Vandenbussche E. Are modern dual mobility cups a valuable option in reducing instability after primary hip arthroplasty, even in younger patients? J Arthroplasty. 2014 Jun;29(6):1323-8. doi: 10.1016/j.arth.2013.12.011. Epub 2013 Dec 16.
Plummer DR, Christy JM, Sporer SM, Paprosky WG, Della Valle CJ. Dual-Mobility Articulations for Patients at High Risk for Dislocation. J Arthroplasty. 2016 Sep;31(9 Suppl):131-5. doi: 10.1016/j.arth.2016.03.021. Epub 2016 Mar 17.
McArthur BA, Nam D, Cross MB, Westrich GH, Sculco TP. Dual-mobility acetabular components in total hip arthroplasty. Am J Orthop (Belle Mead NJ). 2013 Oct;42(10):473-8.
Farizon F, de Lavison R, Azoulai JJ, Bousquet G. Results with a cementless alumina-coated cup with dual mobility. A twelve-year follow-up study. Int Orthop. 1998;22(4):219-24. doi: 10.1007/s002640050246.
Other Identifiers
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17060804
Identifier Type: -
Identifier Source: org_study_id
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