A Prospective Randomized Controlled Trial of Dual-Mobility Components in Primary THA

Serum Metal Levels, Specifically Cobalt, Chromium, and Titanium Clinical Trial

Official title:

A Prospective Randomized Trial of Modular Dual Mobility Acetabular Components Versus Conventional Single Bearing Components in Primary Total Hip Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03371212
• Other study ID #: 17060804
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 15, 2017
• Est. completion date: December 1, 2026

Study information

• Verified date: June 2024
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine if the use of a modular dual mobility bearing is associated with clinically important increases in serum metal levels.

Description:

Prosthetic dislocation following total hip arthroplasty (THA) remains a significant concern with a reported incidence of 0.2%-7.0% after primary and 10%-25% after revision THA. The risk of dislocation following THA is multifactorial and includes both surgeon-related factors (i.e. component positioning, surgical approach) and patient-related factors (i.e. gender, age). Dual mobility articulations have been shown to reduce the incidence of hip instability following THA. Dual mobility implants have been used in Europe for over 30 years, but have recently received an increased interest in the United States.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: December 1, 2026
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 80 years

• 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:

• Clinically significant systemic chronic disease

• 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

Related Conditions & MeSH terms

• Serum Metal Levels, Specifically Cobalt, Chromium, and Titanium

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Zimmer Biomet

Country where clinical trial is conducted

United States, 

References & Publications (14)

Berry DJ. Unstable total hip arthroplasty: detailed overview. Instr Course Lect. 2001;50:265-74. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum chromium levels, measures chromium level in the serum in ug/L	Assays for each subject for serum chromium in ug/L	up to 5 years
Primary	Serum cobalt levels, measures cobalt level in the serum in ug/L	Assays for each subject for serum cobalt in ug/L	up to 5 years
Primary	Serum titanium levels, measures titanium level in the serum in ug/L	Assays for each subject for serum titanium in ug/L	up to 5 years
Secondary	Patient reported outcome measures (survey) for SF-12 score.	Subjects will complete the industry common SF-12 survey and total score will be used. Higher scores are better, score of 100 is maximum.	up to 5 years
Secondary	Patient reported outcome measures (survey) for the Harris Hip Score	Subjects will complete the industry common Harris Hip survey and total score will be used. Higher scores are better, score of 100 is maximum.	up to 5 years
Secondary	Patient reported outcome measures (survey) for the Hoos Jr. score.	Subjects will complete the industry common HOOS Jr. survey and total score will be used. Higher scores are better, score of 100 is maximum.	up to 5 years
Secondary	Patient reported outcome measures (survey) for the SANE score.	Subjects will complete the the industry common SANE survey and total score will be used. Higher scores are better, score of 100 is maximum.	up to 5 years
Secondary	Patient reported outcome measures (survey) for the UCLA activity score.	Subjects will complete the the industry common UCLA survey and total score will be used. Higher scores are better, score of 100 is maximum.	up to 5 years