Dual Mobility in "High Risk" Patients

NCT ID: NCT04092634

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 412 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2035-02-01

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

Conditions

Dislocation, Hip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dual mobility

Patients in this group will receive a dual mobility hip implant

Group Type: EXPERIMENTAL

Dual mobility implant

Intervention Type: DEVICE

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

Single bearing, traditional hip implant

Patients in this group will receive a traditional, single-bearing hip implant.

Group Type: ACTIVE_COMPARATOR

Traditional, Single-bearing hip implant

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York University

OTHER

Sponsor Role: collaborator

Rothman Institute Orthopaedics

OTHER

Sponsor Role: collaborator

Keck School of Medicine of USC

OTHER

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Keck School of Medicine of USC

Los Angeles, California, United States

Rush University Medical Center

Chicago, Illinois, United States

New York University Medical Center

New York, New York, United States

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

17030101

Identifier Type: -

Identifier Source: org_study_id