Dual Mobility in "High Risk" Patients

Last updated: June 24, 2025
Sponsor: Rush University Medical Center
Overall Status: Active - Not Recruiting

Phase

4

Condition

Joint Injuries

Treatment

Dual mobility implant

Traditional, Single-bearing hip implant

Clinical Study ID

NCT04092634
17030101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary THA for a diagnosis of osteoarthritis or inflammatory arthritis in thesetting of a history of prior lumbar or lumbosacral fusion performed at least 6months prior to their THA. In addition, patients considered high-risk for potentialprosthetic dislocation will be included based on the presence of one or more of thefollowing: neuromuscular disorder (e.g. cerebral palsy, Parkinson's disease, historyof a stroke), dementia or cognitive impairment, substance or alcohol abuse (>10drinks per week), acute displaced femoral neck fracture, age > 75 years,inflammatory arthritis, and increased preoperative range of motion (calculated asdescribed by Krenzel et al.: combined flexion, adduction, internal rotation > 115degrees).

Exclusion

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 femurfracture or osteotomy)

  • or a preoperative diagnosis of post-traumatic arthritis, avascular necrosis, orfracture

Study Design

Total Participants: 412
Treatment Group(s): 2
Primary Treatment: Dual mobility implant
Phase: 4
Study Start date:
November 01, 2017
Estimated Completion Date:
February 01, 2035

Study 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

Connect with a study center

  • Keck School of Medicine of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • New York University Medical Center

    New York, New York 10003
    United States

    Site Not Available

  • Rothman Orthopaedic Institute

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

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