Dual Mobility Implant
DevicePatients 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
NCT Number: NCT04092634
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 is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 4
Keck School of Medicine of USC, Los Angeles, California, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 6 weeks following their index surgical procedure.
The rate of prosthetic dislocation between the two cohorts
Time frame: 1 year following their index surgical procedure.
The rate of prosthetic dislocation between the two cohorts
Time frame: 2 years following their index surgical procedure.
The rate of prosthetic dislocation between the two cohorts
Time frame: 5 years following their index surgical procedure.
The rate of prosthetic dislocation between the two cohorts
Time frame: 10 years following their index surgical procedure.
The rate of prosthetic dislocation between the two cohorts
Time frame: Complications will be assess up to 10 years following their index surgical procedure
Any peri- or postoperative complications will be recorded component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates
Time frame: 6 weeks following their index surgical procedure.
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.
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.
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.
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.
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
Rush University Medical Center
Other
Dual-mobility vs. Single-bearing Components in THA at "High Risk" for Prosthetic Dislocation
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