Dual Mobility in "High Risk" Patients

Dislocation, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04092634
• Other study ID #: 17030101
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2017
• Est. completion date: January 1, 2034

Study information

• Verified date: June 2024
• Source: Rush University Medical Center
• Contact: Denis Nam, MD, MSc
• Phone: (312)432-2468
• Email: denis.nam[@]rushortho.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 412
• Est. completion date: January 1, 2034
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dislocation, Hip
• Hip Dislocation

Intervention

Device:
• Dual 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
• Traditional, 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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Keck School of Medicine of USC	Los Angeles	California
United States	New York University Medical Center	New York	New York
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Rush University Medical Center	Keck School of Medicine of USC, New York University, Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip Dislocation	The rate of prosthetic dislocation between the two cohorts	6 weeks following their index surgical procedure.
Primary	Hip Dislocation	The rate of prosthetic dislocation between the two cohorts	1 year following their index surgical procedure.
Primary	Hip Dislocation	The rate of prosthetic dislocation between the two cohorts	2 years following their index surgical procedure.
Primary	Hip Dislocation	The rate of prosthetic dislocation between the two cohorts	5 years following their index surgical procedure.
Primary	Hip Dislocation	The rate of prosthetic dislocation between the two cohorts	10 years following their index surgical procedure.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.