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NCT Number: NCT04090359

Dual Mobility Acetabular Cups in Revision TJA

The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.

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Key information

Conditions

Dislocation, Hip Hip Dislocation Hip Injuries Joint Diseases Joint Dislocations Musculoskeletal Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University Medical Center, New York, United States

Loading trial locations.

About this study

The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any patient older than 18 years of age scheduled for a revision THA, including revision of both components, conversion of a hip resurfacing to THA, conversion of a hemiarthroplasty to THA, and revision of single components which allow implantation of dual-mobility bearings. In addition, patients undergoing reimplantation of a total hip arthroplasty following a two-stage revision for periprosthetic infection will also be included. Only patients with an acetabular shell diameter capable of accommodating at least a 36mm femoral head will be included.

Exclusion criteria

  • Less than 18 years of age, primary THA,
  • conversion of non-arthroplasty femoral neck fracture fixation to THA,
  • patients unwilling to participate.
  • patients where the surgeon makes the intraoperative decision to use a constrained liner will be excluded.

Treatment and study plan

Dual Mobility Implant

Device

Patients in this intervention will receive a dual mobility implant

Conventional, single-bearing implant

Device

Patients in this intervention will receive a conventional, single-bearing implant

Primary outcomes

  1. Prosthetic Dislocation

    Time frame: 6 weeks

    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

  2. Prosthetic Dislocation

    Time frame: 3 months

    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

  3. Prosthetic Dislocation

    Time frame: 2 years

    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

  4. Prosthetic Dislocation

    Time frame: 5 years

    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

  5. Prosthetic Dislocation

    Time frame: 10 years

    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

  6. Prosthetic Dislocation

    Time frame: 15 years

    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

  7. Prosthetic Dislocation

    Time frame: 20 years

    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

Secondary outcomes

  1. Complications

    Time frame: up to 20 years after the patient is discharged from the hospital

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

  2. Routine radiographs assess for loosening and proper component placement

    Time frame: 6 weeks

    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. Radiographics will be assessed for loosening in a yes/no way.

  3. Routine radiographs assess for loosening and proper component placement

    Time frame: 3 months

    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. Radiographics will be assessed for loosening in a yes/no way.

  4. Routine radiographs assess for loosening and proper component placement

    Time frame: 2 years

    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. Radiographics will be assessed for loosening in a yes/no way.

  5. Routine radiographs assess for loosening and proper component placement

    Time frame: 5 years

    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. Radiographics will be assessed for loosening in a yes/no way.

  6. Routine radiographs assess for loosening and proper component placement

    Time frame: 10 years

    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. Radiographics will be assessed for loosening in a yes/no way.

  7. Routine radiographs assess for loosening and proper component placement

    Time frame: 15 years

    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. Radiographics will be assessed for loosening in a yes/no way.

  8. Routine radiographs assess for loosening and proper component placement

    Time frame: 20 years.

    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. Radiographics will be assessed for loosening in a yes/no way.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne DeBenedetti, BA

CONTACT

[email protected]

(312)432-2468

Craig Della Valle, MD

CONTACT

[email protected]

(312)432-2468

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Keck School of Medicine of USC
  • NYU Langone Health
  • Rothman Institute Orthopaedics

Registry information

Important dates

Study start
2017
Primary completion
2026
Study completion
2036
First posted
Sep 16, 2019
Registry last updated
May 5, 2026

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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