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RecruitingNCT04090359Updated May 5, 2026

Dual Mobility Acetabular Cups in Revision TJA

A Phase 4 interventional study of Dual Mobility Implant and Conventional, single-bearing implant in Dislocation, Hip, sponsored by Rush University Medical Center. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Rush University Medical Center · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Sep 2017, registered Sep 2019).
  • Started Sep 2017; still recruiting 9 years 2 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
322
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.

Read the detailed description

The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.

02

Conditions studied

  • Dislocation, Hip

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03

In context

Hip Dislocation

107 studies on the registry are indexed under Hip Dislocation; 36 are open to participants now.

This study's planned enrollment of 322 is above the median of 86 across 64 interventional studies indexed under Hip Dislocation.

Browse Hip Dislocation studies →

Lead sponsor

Rush University Medical Center is the lead sponsor of 397 studies on the registry; 61 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Any patient older than 18 years of age scheduled for a revision THA, including revision of both components, conversion of a hip resurfacing to THA, conversion of a hemiarthroplasty to THA, and revision of single components which allow implantation of dual-mobility bearings. In addition, patients undergoing reimplantation of a total hip arthroplasty following a two-stage revision for periprosthetic infection will also be included. Only patients with an acetabular shell diameter capable of accommodating at least a 36mm femoral head will be included.

Exclusion criteria

Exclusion Criteria:

  • Less than 18 years of age, primary THA,
  • conversion of non-arthroplasty femoral neck fracture fixation to THA,
  • patients unwilling to participate.
  • patients where the surgeon makes the intraoperative decision to use a constrained liner will be excluded.
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
322 participants (estimated)

Study arms

  • Experimental
    Dual Mobility

    If patients are randomized to the dual mobility cohort, they will receive a dual mobility prosthesis at the surgeon's discretion. All surgeries will be performed via the posterior approach, per the participating surgeon's usual standard. Patients will be on postoperative hip precautions for 6 weeks, per departmental protocol. No braces will be utilized.

    Device: Dual Mobility Implant

  • Active comparator
    Conventional, Single-bearing hip implant

    If patients are randomized to the conventional, single bearing cohort, surgeons will use their preferred implant design at their discretion using a 36 or 40mm head, depending on the diameter of the cup and manufacturer specifications. All surgeries will be performed via the posterior approach, per the participating surgeon's usual standard. Patients will be on postoperative hip precautions for 6 weeks, per departmental protocol. No braces will be utilized.

    Device: Conventional, single-bearing implant

Interventions

  • DeviceDual Mobility Implant

    Patients in this intervention will receive a dual mobility implant

  • DeviceConventional, single-bearing implant

    Patients in this intervention will receive a conventional, single-bearing implant

06

What researchers measure

Primary outcomes

  1. Prosthetic Dislocation

    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

    Time frame: 6 weeks

  2. Prosthetic Dislocation

    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

    Time frame: 3 months

  3. Prosthetic Dislocation

    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

    Time frame: 2 years

  4. Prosthetic Dislocation

    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

    Time frame: 5 years

  5. Prosthetic Dislocation

    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

    Time frame: 10 years

  6. Prosthetic Dislocation

    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

    Time frame: 15 years

  7. Prosthetic Dislocation

    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

    Time frame: 20 years

Secondary outcomes

  1. Complications

    Any peri- or postoperative complications will be recorded, including component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates

    Time frame: up to 20 years after the patient is discharged from the hospital

  2. Routine radiographs assess for loosening and proper component placement

    Routine radiographs (AP Pelvis, frogleg lateral, and cross-table lateral radiographs) will be obtained at follow-up visits and assessed for cup placement, anteversion, radiographic signs of loosening, and component migration. Radiographics will be assessed for loosening in a yes/no way.

    Time frame: 6 weeks

  3. Routine radiographs assess for loosening and proper component placement

    Routine radiographs (AP Pelvis, frogleg lateral, and cross-table lateral radiographs) will be obtained at follow-up visits and assessed for cup placement, anteversion, radiographic signs of loosening, and component migration. Radiographics will be assessed for loosening in a yes/no way.

    Time frame: 3 months

  4. Routine radiographs assess for loosening and proper component placement

    Routine radiographs (AP Pelvis, frogleg lateral, and cross-table lateral radiographs) will be obtained at follow-up visits and assessed for cup placement, anteversion, radiographic signs of loosening, and component migration. Radiographics will be assessed for loosening in a yes/no way.

    Time frame: 2 years

  5. Routine radiographs assess for loosening and proper component placement

    Routine radiographs (AP Pelvis, frogleg lateral, and cross-table lateral radiographs) will be obtained at follow-up visits and assessed for cup placement, anteversion, radiographic signs of loosening, and component migration. Radiographics will be assessed for loosening in a yes/no way.

    Time frame: 5 years

  6. Routine radiographs assess for loosening and proper component placement

    Routine radiographs (AP Pelvis, frogleg lateral, and cross-table lateral radiographs) will be obtained at follow-up visits and assessed for cup placement, anteversion, radiographic signs of loosening, and component migration. Radiographics will be assessed for loosening in a yes/no way.

    Time frame: 10 years

  7. Routine radiographs assess for loosening and proper component placement

    Routine radiographs (AP Pelvis, frogleg lateral, and cross-table lateral radiographs) will be obtained at follow-up visits and assessed for cup placement, anteversion, radiographic signs of loosening, and component migration. Radiographics will be assessed for loosening in a yes/no way.

    Time frame: 15 years

  8. Routine radiographs assess for loosening and proper component placement

    Routine radiographs (AP Pelvis, frogleg lateral, and cross-table lateral radiographs) will be obtained at follow-up visits and assessed for cup placement, anteversion, radiographic signs of loosening, and component migration. Radiographics will be assessed for loosening in a yes/no way.

    Time frame: 20 years.

07

Study locations

1 of 2 sites recruiting
08

References and documents

Publications

  • Weintraub MT, DeBenedetti A, Nam D, Darrith B, Baker CM, Waren D, Schwarzkopf R, Courtney PM, Della Valle CJ. Dual-Mobility versus Large Femoral Heads in Revision Total Hip Arthroplasty: Interim Analysis of a Randomized Controlled Trial. J Arthroplasty. 2023 Jul;38(7S):S206-S210. doi: 10.1016/j.arth.2023.03.089. Epub 2023 Apr 3. PubMed 37019309 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2017 (actual). Primary completion is estimated for Nov 2026, 110 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2019
First posted
Sep 16, 2019
StartActual
Sep 1, 2017
Primary completionEst.
Nov 2026
CompletionEst.
Nov 1, 2036
Last update
May 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04090359
Collaborators
Rothman Institute Orthopaedics, Keck School of Medicine of USC, NYU Langone Health
Responsible party
Sponsor
First posted
Sep 16, 2019
Start date
Sep 1, 2017
Primary completion
Nov 2026 (estimated)
Completion
Nov 1, 2036 (estimated)
Last update
May 5, 2026

Study contacts

Craig Della Valle, MD
Contact
craig.dellavalle@rushortho.com
(312)432-2468
Anne DeBenedetti, BA
Contact
anne.debenedetti@rushortho.com
(312)432-2468

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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