Clinical trial NCT03371212: A Prospective Randomized Controlled Trial of Dual-Mobility Components in Primary THA
Official title: A Prospective Randomized Trial of Modular Dual Mobility Acetabular Components Versus Conventional Single Bearing Components in Primary Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Serum Metal Levels, Specifically Cobalt, Chromium, and Titanium
Keywords: Dual Mobility
Serum metal levels
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2017-12-13
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Serum chromium levels, measures chromium level in the serum in ug/L
timeFrame: up to 5 years
measure: Serum cobalt levels, measures cobalt level in the serum in ug/L
timeFrame: up to 5 years
measure: Serum titanium levels, measures titanium level in the serum in ug/L
timeFrame: up to 5 years
Secondary outcomes:
measure: Patient reported outcome measures (survey) for SF-12 score.
timeFrame: up to 5 years
measure: Patient reported outcome measures (survey) for the Harris Hip Score
timeFrame: up to 5 years
measure: Patient reported outcome measures (survey) for the Hoos Jr. score.
timeFrame: up to 5 years
measure: Patient reported outcome measures (survey) for the SANE score.
timeFrame: up to 5 years
measure: Patient reported outcome measures (survey) for the UCLA activity score.
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
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