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Dual Mobility Acetabular Cups in Revision TJA

Primary Purpose

Dislocation, Hip

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dual Mobility Implant
Conventional, single-bearing implant
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dislocation, Hip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University Medical Center
  • Rothman InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dual Mobility

Conventional, Single-bearing hip implant

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complications
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
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
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
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
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
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
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
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.

Full Information

First Posted
September 11, 2019
Last Updated
October 19, 2023
Sponsor
Rush University Medical Center
Collaborators
Rothman Institute Orthopaedics, NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04090359
Brief Title
Dual Mobility Acetabular Cups in Revision TJA
Official Title
Dual Mobility Acetabular Cups in Revision TJA
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
September 1, 2034 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
Rothman Institute Orthopaedics, NYU Langone Health

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dislocation, Hip

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
322 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual Mobility
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional, Single-bearing hip implant
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Dual Mobility Implant
Intervention Description
Patients in this intervention will receive a dual mobility implant
Intervention Type
Device
Intervention Name(s)
Conventional, single-bearing implant
Intervention Description
Patients in this intervention will receive a conventional, single-bearing implant
Primary Outcome Measure Information:
Title
Prosthetic Dislocation
Description
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Time Frame
6 weeks
Title
Prosthetic Dislocation
Description
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Time Frame
3 months
Title
Prosthetic Dislocation
Description
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Time Frame
2 years
Title
Prosthetic Dislocation
Description
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Time Frame
5 years
Title
Prosthetic Dislocation
Description
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Time Frame
10 years
Title
Prosthetic Dislocation
Description
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Time Frame
15 years
Title
Prosthetic Dislocation
Description
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Time Frame
20 years
Secondary Outcome Measure Information:
Title
Complications
Description
Any peri- or postoperative complications will be recorded, including component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates
Time Frame
up to 20 years after the patient is discharged from the hospital
Title
Routine radiographs assess for loosening and proper component placement
Description
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.
Time Frame
6 weeks
Title
Routine radiographs assess for loosening and proper component placement
Description
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.
Time Frame
3 months
Title
Routine radiographs assess for loosening and proper component placement
Description
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.
Time Frame
2 years
Title
Routine radiographs assess for loosening and proper component placement
Description
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.
Time Frame
5 years
Title
Routine radiographs assess for loosening and proper component placement
Description
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.
Time Frame
10 years
Title
Routine radiographs assess for loosening and proper component placement
Description
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.
Time Frame
15 years
Title
Routine radiographs assess for loosening and proper component placement
Description
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.
Time Frame
20 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Craig Della Valle, MD
Phone
(312)432-2468
Email
craig.dellavalle@rushortho.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anne DeBenedetti, BA
Phone
(312)432-2468
Email
anne.debenedetti@rushortho.com
Facility Information:
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Schwarzkopf, MD
Email
Ran.Schwarzkopf@nyumc.org
First Name & Middle Initial & Last Name & Degree
Daniel Warren
Email
daniel.warren@nyumc.org
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Max Courtney, MD
Email
p.maxwell.courtney@rothmanortho.com
First Name & Middle Initial & Last Name & Degree
William Li, BA
Email
william.li@rothmanortho.com
First Name & Middle Initial & Last Name & Degree
Javad Parvizi, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dual Mobility Acetabular Cups in Revision TJA

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