Dual Mobility in "High Risk" Patients

NCT04092634 | Active Not Recruiting Phase 4 FDA Device

• 1 other identifier: 17030101
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 4

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.

Conditions

Dislocation, Hip

Outcome Measures

Primary Outcomes (5)

• Hip Dislocation

  The rate of prosthetic dislocation between the two cohorts

  6 weeks following their index surgical procedure.

• Hip Dislocation

  The rate of prosthetic dislocation between the two cohorts

  1 year following their index surgical procedure.

• Hip Dislocation

  The rate of prosthetic dislocation between the two cohorts

  2 years following their index surgical procedure.

• Hip Dislocation

  The rate of prosthetic dislocation between the two cohorts

  5 years following their index surgical procedure.

• Hip Dislocation

  The rate of prosthetic dislocation between the two cohorts

  10 years following their index surgical procedure.

Secondary Outcomes (6)

• Complications

  Complications will be assess up to 10 years following their index surgical procedure

• Radiographic signs of loosening and proper component placement.

  6 weeks following their index surgical procedure.

• Radiographic signs of loosening and proper component placement.

  1 year following their index surgical procedure.

• Radiographic signs of loosening and proper component placement.

  2 years following their index surgical procedure.

• Radiographic signs of loosening and proper component placement.

  5 years following their index surgical procedure.

Study Arms (2)

Dual mobility

EXPERIMENTAL

Patients in this group will receive a dual mobility hip implant

Device: Dual mobility implant

Single bearing, traditional hip implant

ACTIVE COMPARATOR

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

Device: Traditional, Single-bearing hip implant

Interventions

Dual mobility implant 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

Dual mobility

Traditional, Single-bearing hip implant 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• New York University: collaborator
• Rothman Institute Orthopaedics: collaborator
• Keck School of Medicine of USC: collaborator

Study Sites (4)

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

New York University Medical Center

New York, New York, 10003, United States

Location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with two groups: THA with dual mobility components vs THA with single-bearing designs.

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 17, 2019
• Study Start: November 1, 2017
• Primary Completion: June 1, 2025
• Study Completion (Estimated): February 1, 2035
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)