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.

Study Overview

• Status: Recruiting
• Conditions: Dislocation, Hip
• Intervention / Treatment: Device: Dual Mobility Implant; Device: Conventional, single-bearing implant

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: Interventional
• Enrollment (Estimated): 322
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anne DeBenedetti, BA; Phone Number: (312)432-2468; Email: anne.debenedetti@rushortho.com
• Study Contact Backup: Name: Craig Della Valle, MD; Phone Number: (312)432-2468; Email: craig.dellavalle@rushortho.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Not yet recruiting
      • New York University Medical Center
      • Contact: Ran Schwarzkopf, MD; Email: Ran.Schwarzkopf@nyumc.org
      • Contact: Daniel Warren; Email: daniel.warren@nyumc.org
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Rothman Institute
      • Contact: Max Courtney, MD; Email: p.maxwell.courtney@rothmanortho.com
      • Contact: William Li, BA; Email: william.li@rothmanortho.com
      • Principal Investigator: Javad Parvizi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosthetic Dislocation	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits	6 weeks
Prosthetic Dislocation	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits	3 months
Prosthetic Dislocation	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits	2 years
Prosthetic Dislocation	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits	5 years
Prosthetic Dislocation	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits	10 years
Prosthetic Dislocation	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits	15 years
Prosthetic Dislocation	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits	20 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Any peri- or postoperative complications will be recorded, including component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates	up to 20 years after the patient is discharged from the hospital
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.	6 weeks
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.	3 months
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.	2 years
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.	5 years
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.	10 years
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.	15 years
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.	20 years.

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: NYU Langone Health; Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): September 1, 2034

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Joint Dislocations; Hip Dislocation
• Other Study ID Numbers: 17022801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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