Dislocation, Hip
Conditions
Brief 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.
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
Interventions
DEVICEDual 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
DEVICETraditional, 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
Sponsors
New York University
Rothman Institute Orthopaedics
Keck School of Medicine of USC
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized controlled trial with two groups: THA with dual mobility components vs THA with single-bearing designs.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hip Dislocation | 6 weeks following their index surgical procedure. | The rate of prosthetic dislocation between the two cohorts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 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 |
| Radiographic signs of loosening and proper component placement. | 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 |
Countries
United States
Outcome results
None listed