Dislocation, HipPhase 4NCT04092634
Dual Mobility in "High Risk" Patients
A Phase 4 study testing Dual mobility implant and Traditional, Single-bearing hip implant in people with Dislocation, Hip, run by Rush University Medical Center at 4 sites in United States.
Trial summary
The aim of this study is to compare clinical outcomes of patients considered to be high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single bearing design. 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 Traditional, Single-bearing hip implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Nov 2017to 1 Feb 2035
- 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
- Primary THA for a diagnosis of osteoarthritis or inflammatory arthritis in the setting of a history of prior lumbar or lumbosacral fusion performed at least 6 months prior to their THA. In addition, patients considered high-risk for potential prosthetic dislocation will be included based on the presence of one or more of the following: neuromuscular disorder (e.g. cerebral palsy, Parkinson's disease, history of a stroke), dementia or cognitive impairment, substance or alcohol abuse (>10 drinks per week), acute displaced femoral neck fracture, age > 75 years, inflammatory arthritis, and increased preoperative range of motion (calculated as described by Krenzel et al.: combined flexion, adduction, internal rotation > 115 degrees).
Who cannot join
- Less than 18 years of age
- Revision THA
- spinopelvic fusion that is more recent than 6 months prior to THA
- isolated cervical or thoracic fusion
- intent to undergo a revision spinopelvic fusion within one year of their index THA
- a history of prior infection in the affected hip
- a history of prior open surgery on the affected hip (i.e. prior proximal femur fracture or osteotomy)
- or a preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rush University Medical Center
Chicago, Illinois, 60612
Keck School of Medicine of USC
Los Angeles, California, 90033
New York University Medical Center
New York, New York, 10003
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Dual-mobility vs. Single-bearing Components in THA at "High Risk" for Prosthetic Dislocation
The aim of this study is to compare clinical outcomes of patients considered to be high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single bearing design.
Read the detailed description
This study aims to compare the clinical outcomes of patients considered to be at high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single-bearing design.
We hypothesize that in primary THA patients considered to be at high risk for prosthetic dislocation, the use of dual-mobility components will be associated with a lower dislocation rate in the first year following the index procedure. We do not anticipate a difference. In other clinical outcome measures or functional outcome scores between the two cohorts.
Study Design: Randomized controlled trial with two groups: THA with dual mobility.
44 components vs THA with single-bearing designs
- Conditions
- Dislocation, Hip
- Being tested
- Dual mobility implant, Traditional, Single-bearing hip 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 that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant
Traditional, Single-bearing hip implantDevice
Patients that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant
| Study group | Role | What they receive |
|---|---|---|
| Dual mobility | Experimental | Patients in this group will receive a dual mobility hip implant Receives: Device: Dual mobility implant |
| Single bearing, traditional hip implant | Active comparator | Patients in this group will receive a traditional, single-bearing hip implant. Receives: Device: Traditional, Single-bearing hip implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Measured: 6 weeks following their index surgical procedure.
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Measured: 1 year following their index surgical procedure.
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Measured: 2 years following their index surgical procedure.
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Measured: 5 years following their index surgical procedure.
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Measured: 10 years following their index surgical procedure.
Secondary outcomes (6)
Complications
Any peri- or postoperative complications will be recorded component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates
Measured: Complications will be assess up to 10 years following their index surgical procedure
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format
Measured: 6 weeks following their index surgical procedure.
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format
Measured: 1 year following their index surgical procedure.
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format
Measured: 2 years following their index surgical procedure.
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format
Measured: 5 years following their index surgical procedure.
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format
Measured: 10 years following their index surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start1 Nov 2017
- Primary completion1 Jun 2025
- Study completion1 Feb 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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: THA with dual mobility components vs THA with single-bearing designs.
- Masking
- None (open label)
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- New York University, Rothman Institute Orthopaedics, Keck School of Medicine of USC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092634
- Sponsor's protocol ID
- 17030101
- Status last verified
- Jun 2025
- First submitted
- 11 Sep 2019
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-mobility vs. Single-bearing Components in THA at "High Risk" for Prosthetic Dislocation
- ClinicalTrials.gov ID
- NCT04092634
- Acronym / sponsor ID
- 17030101
- Conditions
- Dislocation, Hip
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- New York University, Rothman Institute Orthopaedics, Keck School of Medicine of USC
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Feb 2035 (estimated)
- First posted
- 17 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 compare clinical outcomes of patients considered to be high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single bearing design.
Detailed description
This study aims to compare the clinical outcomes of patients considered to be at high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single-bearing design.
We hypothesize that in primary THA patients considered to be at high risk for prosthetic dislocation, the use of dual-mobility components will be associated with a lower dislocation rate in the first year following the index procedure. We do not anticipate a difference. In other clinical outcome measures or functional outcome scores between the two cohorts.
Study Design: Randomized controlled trial with two groups: THA with dual mobility.
44 components vs THA with single-bearing designs
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: THA with dual mobility components vs THA with single-bearing designs.
| Arm | Type | Receives |
|---|---|---|
| Dual mobility | Experimental | Device: Dual mobility implantPatients in this group will receive a dual mobility hip implant |
| Single bearing, traditional hip implant | Active comparator | Device: Traditional, Single-bearing hip implantPatients in this group will receive a traditional, single-bearing hip implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary THA for a diagnosis of osteoarthritis or inflammatory arthritis in the setting of a history of prior lumbar or lumbosacral fusion performed at least 6 months prior to their THA. In addition, patients considered high-risk for potential prosthetic dislocation will be included based on the presence of one or more of the following: neuromuscular disorder (e.g. cerebral palsy, Parkinson's disease, history of a stroke), dementia or cognitive impairment, substance or alcohol abuse (>10 drinks per week), acute displaced femoral neck fracture, age > 75 years, inflammatory arthritis, and increased preoperative range of motion (calculated as described by Krenzel et al.: combined flexion, adduction, internal rotation > 115 degrees).
Key exclusion criteria (8 listed)
- Less than 18 years of age
- Revision THA
- spinopelvic fusion that is more recent than 6 months prior to THA
- isolated cervical or thoracic fusion
- intent to undergo a revision spinopelvic fusion within one year of their index THA
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 that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant | Device | Dual mobility |
| Traditional, Single-bearing hip implantPatients that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant | Device | Single bearing, traditional hip implant |
Primary outcome
Hip Dislocation
Time frame: 6 weeks following their index surgical procedure.
The rate of prosthetic dislocation between the two cohorts
Hip Dislocation
Time frame: 1 year following their index surgical procedure.
The rate of prosthetic dislocation between the two cohorts
Hip Dislocation
Time frame: 2 years following their index surgical procedure.
The rate of prosthetic dislocation between the two cohorts
Hip Dislocation
Time frame: 5 years following their index surgical procedure.
The rate of prosthetic dislocation between the two cohorts
Hip Dislocation
Time frame: 10 years following their index surgical procedure.
The rate of prosthetic dislocation between the two cohorts
6 secondary outcomes
Complications
Time frame: Complications will be assess up to 10 years following their index surgical procedure
Radiographic signs of loosening and proper component placement.
Time frame: 6 weeks following their index surgical procedure.
Radiographic signs of loosening and proper component placement.
Time frame: 1 year following their index surgical procedure.
Radiographic signs of loosening and proper component placement.
Time frame: 2 years following their index surgical procedure.
Radiographic signs of loosening and proper component placement.
Time frame: 5 years following their index surgical procedure.
Radiographic signs of loosening and proper component placement.
Time frame: 10 years following their index surgical procedure.
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 26 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Dislocation, Hip
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
RecruitingObservational study
The Medacta International SMS Post-Marketing Surveillance Study
Arthrosis, Traumatic Arthritis
Active, not recruitingObservational study
The Medacta Quadra-P Anteverted Study
Arthrosis, Traumatic Arthritis
RecruitingPhase 4
E-Type - Early Wear of Polyethylene Liners Used in DMC
Osteoarthritis, Osteonecrosis
Active, not recruitingObservational study
Prospective Study for the Evaluation of the Cementless Anatomic Femoral Stem Minimax -Launay
Primary Osteoarthritis, Secondary Osteoarthritis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 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 Traditional, Single-bearing hip implant in people with Dislocation, Hip, run by Rush University Medical Center at 4 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 8 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip Dislocation (time frame: 6 weeks following their index surgical procedure.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2025.