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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03371212
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Rush University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Serum Metal Levels, Specifically Cobalt, Chromium, and Titanium Device: Dual mobility cohort Device: Conventional cohort Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to 1 of 2 treatment groups, which they will be in for the duration of the study. Because of the nature of the study, there will be no crossover.
Masking: Single (Participant)
Masking Description: The patient will not have information about the treatment group they've been assigned to until after surgery.
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Modular Dual Mobility Acetabular Components Versus Conventional Single Bearing Components in Primary Total Hip Arthroplasty
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2024

Arm Intervention/treatment
Active Comparator: 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.
Device: 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

Experimental: 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.
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.




Primary Outcome Measures :
  1. Serum chromium levels, measures chromium level in the serum in ug/L [ Time Frame: up to 5 years ]
    Assays for each subject for serum chromium in ug/L

  2. Serum cobalt levels, measures cobalt level in the serum in ug/L [ Time Frame: up to 5 years ]
    Assays for each subject for serum cobalt in ug/L

  3. Serum titanium levels, measures titanium level in the serum in ug/L [ Time Frame: up to 5 years ]
    Assays for each subject for serum titanium in ug/L


Secondary Outcome Measures :
  1. Patient reported outcome measures (survey) for SF-12 score. [ Time Frame: up to 5 years ]
    Subjects will complete the industry common SF-12 survey and total score will be used. Higher scores are better, score of 100 is maximum.

  2. Patient reported outcome measures (survey) for the Harris Hip Score [ Time Frame: up to 5 years ]
    Subjects will complete the industry common Harris Hip survey and total score will be used. Higher scores are better, score of 100 is maximum.

  3. Patient reported outcome measures (survey) for the Hoos Jr. score. [ Time Frame: up to 5 years ]
    Subjects will complete the industry common HOOS Jr. survey and total score will be used. Higher scores are better, score of 100 is maximum.

  4. Patient reported outcome measures (survey) for the SANE score. [ Time Frame: up to 5 years ]
    Subjects will complete the the industry common SANE survey and total score will be used. Higher scores are better, score of 100 is maximum.

  5. Patient reported outcome measures (survey) for the UCLA activity score. [ Time Frame: up to 5 years ]
    Subjects will complete the the industry common UCLA survey and total score will be used. Higher scores are better, score of 100 is maximum.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371212


Contacts
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Contact: Chris Culvern, MS 312-432-2470 chris.culvern@rushortho.com

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Chris Culvern, MS    312-432-2470    chris.culvern@rushortho.com   
Sponsors and Collaborators
Rush University Medical Center
Zimmer Biomet
Publications:

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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03371212    
Other Study ID Numbers: 17060804
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Rush University Medical Center:
Dual Mobility
Serum metal levels