A Phase 4 interventional study of Dual mobility implant and Traditional, Single-bearing hip implant in Dislocation, Hip, sponsored by Rush University Medical Center. Active, not recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Rush University Medical Center · Phase 4, Interventional, and Prevention
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.
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
107 studies on the registry are indexed under Hip Dislocation; 36 are open to participants now.
This study's planned enrollment of 412 is above the median of 86 across 64 interventional studies indexed under Hip Dislocation.
Browse Hip Dislocation studies →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.
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Exclusion Criteria:
Patients in this group will receive a dual mobility hip implant
Device: Dual mobility implant
Patients in this group will receive a traditional, single-bearing hip implant.
Device: Traditional, Single-bearing hip implant
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
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
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Time frame: 6 weeks following their index surgical procedure.
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Time frame: 1 year following their index surgical procedure.
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Time frame: 2 years following their index surgical procedure.
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Time frame: 5 years following their index surgical procedure.
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Time frame: 10 years following their index surgical procedure.
Complications
Any peri- or postoperative complications will be recorded component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 years following their index surgical procedure.
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Jun 2025, 91 months.
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