Clinical trial NCT04092634: Dual Mobility in "High Risk" Patients
Official title: Dual-mobility vs. Single-bearing Components in THA at "High Risk" for Prosthetic Dislocation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dislocation, Hip
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: New York University
name: Rothman Institute Orthopaedics
name: Keck School of Medicine of USC
First posted: 2019-09-17
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two groups: THA with dual mobility components vs THA with single-bearing designs.
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Hip Dislocation
timeFrame: 6 weeks following their index surgical procedure.
measure: Hip Dislocation
timeFrame: 1 year following their index surgical procedure.
measure: Hip Dislocation
timeFrame: 2 years following their index surgical procedure.
measure: Hip Dislocation
timeFrame: 5 years following their index surgical procedure.
measure: Hip Dislocation
timeFrame: 10 years following their index surgical procedure.
Secondary outcomes:
measure: Complications
timeFrame: Complications will be assess up to 10 years following their index surgical procedure
measure: Radiographic signs of loosening and proper component placement.
timeFrame: 6 weeks following their index surgical procedure.
measure: Radiographic signs of loosening and proper component placement.
timeFrame: 1 year following their index surgical procedure.
measure: Radiographic signs of loosening and proper component placement.
timeFrame: 2 years following their index surgical procedure.
measure: Radiographic signs of loosening and proper component placement.
timeFrame: 5 years following their index surgical procedure.
measure: Radiographic signs of loosening and proper component placement.
timeFrame: 10 years following their index surgical procedure.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References: