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Dual Mobility Acetabular Cups in Revision TJA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 11, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date September 16, 2019
Actual Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • Prosthetic Dislocation [ Time Frame: 6 weeks ]
    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
  • Prosthetic Dislocation [ Time Frame: 3 months ]
    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
  • Prosthetic Dislocation [ Time Frame: 2 years ]
    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
  • Prosthetic Dislocation [ Time Frame: 5 years ]
    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
  • Prosthetic Dislocation [ Time Frame: 10 years ]
    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
  • Prosthetic Dislocation [ Time Frame: 15 years ]
    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
  • Prosthetic Dislocation [ Time Frame: 20 years ]
    The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dual Mobility Acetabular Cups in Revision TJA
Official Title  ICMJE Dual Mobility Acetabular Cups in Revision TJA
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Dislocation, Hip
Intervention  ICMJE
  • Device: Dual Mobility Implant
    Patients in this intervention will receive a dual mobility implant
  • Device: Conventional, single-bearing implant
    Patients in this intervention will receive a conventional, single-bearing implant
Study Arms  ICMJE
  • 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.
    Intervention: Device: 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.
    Intervention: Device: Conventional, single-bearing implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2019)
322
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2042
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Craig Della Valle, MD (312)432-2468 craig.dellavalle@rushortho.com
Contact: Anne DeBenedetti, BA (312)432-2468 anne.debenedetti@rushortho.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04090359
Other Study ID Numbers  ICMJE 17022801
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE
  • Rothman Orthopaedic Institute
  • NYU Langone Health
Investigators  ICMJE Not Provided
PRS Account Rush University Medical Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP