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Dual Mobility Acetabular Cups in Revision TJA

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ClinicalTrials.gov Identifier: NCT04090359
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Collaborators:
Rothman Orthopaedic Institute
NYU Langone Health
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dislocation, Hip Device: Dual Mobility Implant Device: Conventional, single-bearing implant Phase 4

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial with two groups: revision THA with dual mobility components vs revision THA with large head, single bearing designs (36mm and 40mm).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Dual Mobility Acetabular Cups in Revision TJA
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2042

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations

Arm Intervention/treatment
Experimental: Dual Mobility
If patients are randomized to the dual mobility cohort, they will receive a dual mobility prosthesis at the surgeon's discretion. All surgeries will be performed via the posterior approach, per the participating surgeon's usual standard. Patients will be on postoperative hip precautions for 6 weeks, per departmental protocol. No braces will be utilized.
Device: Dual Mobility Implant
Patients in this intervention will receive a dual mobility implant

Active Comparator: Conventional, Single-bearing hip implant
If patients are randomized to the conventional, single bearing cohort, surgeons will use their preferred implant design at their discretion using a 36 or 40mm head, depending on the diameter of the cup and manufacturer specifications. All surgeries will be performed via the posterior approach, per the participating surgeon's usual standard. Patients will be on postoperative hip precautions for 6 weeks, per departmental protocol. No braces will be utilized.
Device: Conventional, single-bearing implant
Patients in this intervention will receive a conventional, single-bearing implant




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090359


Contacts
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Contact: Craig Della Valle, MD (312)432-2468 craig.dellavalle@rushortho.com
Contact: Anne DeBenedetti, BA (312)432-2468 anne.debenedetti@rushortho.com

Locations
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United States, New York
New York University Medical Center Not yet recruiting
New York, New York, United States, 10003
Contact: Ran Schwarzkopf, MD       Ran.Schwarzkopf@nyumc.org   
Contact: Daniel Warren       daniel.warren@nyumc.org   
United States, Pennsylvania
Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Max Courtney, MD       p.maxwell.courtney@rothmanortho.com   
Contact: William Li, BA       william.li@rothmanortho.com   
Principal Investigator: Javad Parvizi, MD         
Sponsors and Collaborators
Rush University Medical Center
Rothman Orthopaedic Institute
NYU Langone Health

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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04090359     History of Changes
Other Study ID Numbers: 17022801
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hip Dislocation
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Hip Injuries