Dislocation, HipPhase 4NCT04090359
Dual Mobility Acetabular Cups in Revision TJA
A Phase 4 study testing Dual Mobility Implant and Conventional, single-bearing implant in people with Dislocation, Hip, run by Rush University Medical Center at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dislocation, Hip
- What is being tested?
- Dual Mobility Implant and Conventional, single-bearing implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2017to 1 Nov 2036
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
New York University Medical Center
New York, New York, 10003
Ran Schwarzkopf, MD, Ran.Schwarzkopf@nyumc.org
Daniel Warren, daniel.warren@nyumc.org
- Recruiting
Rothman Institute
Philadelphia, Pennsylvania, 19107
Max Courtney, MD, p.maxwell.courtney@rothmanortho.com
William Li, BA, william.li@rothmanortho.com
About this study
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.
- Conditions
- Dislocation, Hip
- Being tested
- Dual Mobility Implant, Conventional, single-bearing implant
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Mobility ImplantDevice
Patients in this intervention will receive a dual mobility implant
Conventional, single-bearing implantDevice
Patients in this intervention will receive a conventional, single-bearing implant
| Study group | Role | What they receive |
|---|---|---|
| Dual Mobility | Experimental | 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. Receives: Device: Dual Mobility Implant |
| Conventional, Single-bearing hip implant | Active comparator | 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. Receives: Device: Conventional, single-bearing implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic Dislocation
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Measured: 6 weeks
Prosthetic Dislocation
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Measured: 3 months
Prosthetic Dislocation
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Measured: 2 years
Prosthetic Dislocation
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Measured: 5 years
Prosthetic Dislocation
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Measured: 10 years
Prosthetic Dislocation
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Measured: 15 years
Prosthetic Dislocation
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Measured: 20 years
Secondary outcomes (8)
Complications
Any peri- or postoperative complications will be recorded, including component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates
Measured: up to 20 years after the patient is discharged from the hospital
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.
Measured: 6 weeks
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.
Measured: 3 months
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.
Measured: 2 years
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.
Measured: 5 years
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.
Measured: 10 years
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.
Measured: 15 years
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.
Measured: 20 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start1 Sep 2017
- Primary completionNov 2026 (estimated)
- Study completion1 Nov 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dislocation, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two groups: revision THA with dual mobility components vs revision THA with large head, single bearing designs (36mm and 40mm).
- Masking
- None (open label)
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rothman Institute Orthopaedics, Keck School of Medicine of USC, NYU Langone Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090359
- Sponsor's protocol ID
- 17022801
- Status last verified
- Apr 2026
- First submitted
- 11 Sep 2019
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Mobility Acetabular Cups in Revision TJA
- ClinicalTrials.gov ID
- NCT04090359
- Acronym / sponsor ID
- 17022801
- Conditions
- Dislocation, Hip
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Rothman Institute Orthopaedics, Keck School of Medicine of USC, NYU Langone Health
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- 1 Nov 2036 (estimated)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two groups: revision THA with dual mobility components vs revision THA with large head, single bearing designs (36mm and 40mm).
| Arm | Type | Receives |
|---|---|---|
| Dual Mobility | Experimental | Device: Dual Mobility ImplantIf 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. |
| Conventional, Single-bearing hip implant | Active comparator | Device: Conventional, single-bearing implantIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual Mobility ImplantPatients in this intervention will receive a dual mobility implant | Device | Dual Mobility |
| Conventional, single-bearing implantPatients in this intervention will receive a conventional, single-bearing implant | Device | Conventional, Single-bearing hip implant |
Primary outcome
Prosthetic Dislocation
Time frame: 6 weeks
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Prosthetic Dislocation
Time frame: 3 months
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Prosthetic Dislocation
Time frame: 2 years
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Prosthetic Dislocation
Time frame: 5 years
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Prosthetic Dislocation
Time frame: 10 years
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Prosthetic Dislocation
Time frame: 15 years
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Prosthetic Dislocation
Time frame: 20 years
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
8 secondary outcomes
Complications
Time frame: up to 20 years after the patient is discharged from the hospital
Routine radiographs assess for loosening and proper component placement
Time frame: 6 weeks
Routine radiographs assess for loosening and proper component placement
Time frame: 3 months
Routine radiographs assess for loosening and proper component placement
Time frame: 2 years
Routine radiographs assess for loosening and proper component placement
Time frame: 5 years
Routine radiographs assess for loosening and proper component placement
Time frame: 10 years
Routine radiographs assess for loosening and proper component placement
Time frame: 15 years
Routine radiographs assess for loosening and proper component placement
Time frame: 20 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 37019309Weintraub 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dual Mobility Implant and Conventional, single-bearing implant in people with Dislocation, Hip, run by Rush University Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Craig Della Valle, MD ((312)432-2468, craig.dellavalle@rushortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic Dislocation (time frame: 6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04090359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.