Status:
ACTIVE_NOT_RECRUITING
Dual Mobility in "High Risk" Patients
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
New York University
Rothman Institute Orthopaedics
Conditions:
Dislocation, Hip
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 be...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2035
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT04092634
Start Date
November 1 2017
End Date
February 1 2035
Last Update
June 26 2025
Active Locations (4)
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1
Keck School of Medicine of USC
Los Angeles, California, United States, 90033
2
Rush University Medical Center
Chicago, Illinois, United States, 60612
3
New York University Medical Center
New York, New York, United States, 10003
4
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107