Dual Mobility in High Risk Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Dual-mobility vs. Single-bearing Components in THA at High Risk for Prosthetic Dislocation

Conditions
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Dislocation, Hip

Intervention / Treatment
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* Device: Dual mobility implant
* Device: Traditional, Single-bearing hip implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with two groups: THA with dual mobility components vs THA with single-bearing designs.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual mobility<br>Patients in this group will receive a dual mobility hip implant | Device: Dual mobility implant<br>* 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<br>|
| Active Comparator: Single bearing, traditional hip implant<br>Patients in this group will receive a traditional, single-bearing hip implant. | Device: Traditional, Single-bearing hip implant<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip Dislocation | The rate of prosthetic dislocation between the two cohorts | 6 weeks following their index surgical procedure. | 
| Hip Dislocation | The rate of prosthetic dislocation between the two cohorts | 1 year following their index surgical procedure. | 
| Hip Dislocation | The rate of prosthetic dislocation between the two cohorts | 2 years following their index surgical procedure. | 
| Hip Dislocation | The rate of prosthetic dislocation between the two cohorts | 5 years following their index surgical procedure. | 
| Hip Dislocation | The rate of prosthetic dislocation between the two cohorts | 10 years following their index surgical procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Any peri- or postoperative complications will be recorded component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates | 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 | 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 | 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 | 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 | 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 | 10 years following their index surgical procedure. |