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

August 29, 2023 updated by: Rush University Medical Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 5 years
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
up to 5 years
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
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 5 years
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.
up to 5 years
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.
up to 5 years
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.
up to 5 years
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.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

Zimmer Biomet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2017

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 13, 2017

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17060804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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