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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
322
Patients in this intervention will receive a dual mobility implant
Patients in this intervention will receive a conventional, single-bearing implant
New York University Medical Center
New York, New York, United States
NOT_YET_RECRUITINGRothman Institute
Philadelphia, Pennsylvania, United States
RECRUITINGProsthetic Dislocation
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Time frame: 6 weeks
Prosthetic Dislocation
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Time frame: 3 months
Prosthetic Dislocation
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Time frame: 2 years
Prosthetic Dislocation
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Time frame: 5 years
Prosthetic Dislocation
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Time frame: 10 years
Prosthetic Dislocation
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Time frame: 15 years
Prosthetic Dislocation
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Time frame: 20 years
Complications
Any peri- or postoperative complications will be recorded, including component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 20 years.