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Active, Not Recruiting

NCT Number: NCT04092634

Dual Mobility in "High Risk" Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Keck School of Medicine of USC, Los Angeles, California, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Hip Dislocation

    Time frame: 6 weeks following their index surgical procedure.

    The rate of prosthetic dislocation between the two cohorts

  2. Hip Dislocation

    Time frame: 1 year following their index surgical procedure.

    The rate of prosthetic dislocation between the two cohorts

  3. Hip Dislocation

    Time frame: 2 years following their index surgical procedure.

    The rate of prosthetic dislocation between the two cohorts

  4. Hip Dislocation

    Time frame: 5 years following their index surgical procedure.

    The rate of prosthetic dislocation between the two cohorts

  5. Hip Dislocation

    Time frame: 10 years following their index surgical procedure.

    The rate of prosthetic dislocation between the two cohorts

Secondary outcomes

  1. Complications

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

    Any peri- or postoperative complications will be recorded component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates

  2. Radiographic signs of loosening and proper component placement.

    Time frame: 6 weeks following their index surgical procedure.

    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

  3. Radiographic signs of loosening and proper component placement.

    Time frame: 1 year following their index surgical procedure.

    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

  4. Radiographic signs of loosening and proper component placement.

    Time frame: 2 years following their index surgical procedure.

    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. Radiographic signs of loosening and proper component placement.

    Time frame: 5 years following their index surgical procedure.

    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. Radiographic signs of loosening and proper component placement.

    Time frame: 10 years following their index surgical procedure.

    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

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Keck School of Medicine of USC
  • New York University
  • Rothman Institute Orthopaedics

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2025
Study completion
2035
First posted
Sep 17, 2019
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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