Dual Mobility in "High Risk" Patients

Dual-mobility vs. Single-bearing Components in THA at "High Risk" for Prosthetic Dislocation

The aim of this study is to compare clinical outcomes of patients considered to be high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single bearing design.

Study Overview

• Status: Recruiting
• Conditions: Dislocation, Hip
• Intervention / Treatment: Device: Dual mobility implant; Device: Traditional, Single-bearing hip implant

Detailed Description

This study aims to compare the clinical outcomes of patients considered to be at high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single-bearing design.

We hypothesize that in primary THA patients considered to be at high risk for prosthetic dislocation, the use of dual-mobility components will be associated with a lower dislocation rate in the first year following the index procedure. We do not anticipate a difference. In other clinical outcome measures or functional outcome scores between the two cohorts.

Study Design: Randomized controlled trial with two groups: THA with dual mobility.

44 components vs THA with single-bearing designs

• Study Type: Interventional
• Enrollment (Estimated): 412
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Denis Nam, MD, MSc; Phone Number: (312)432-2468; Email: denis.nam@rushortho.com
• Study Contact Backup: Name: Anne DeBenedetti, BA; Phone Number: (312)432-2468; Email: anne.debenedetti@rushortho.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Keck School of Medicine of USC
      • Contact: Nathan Heckmann, MD
      • Contact: Brian Chung
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Anne DeBenedetti, BA; Phone Number: 312-432-2468; Email: anne.debenedetti@rushortho.com
  • New York
    • New York, New York, United States, 10003
      • Not yet recruiting
      • New York University Medical Center
      • Contact: Ran Schwarzkopf, MD; Phone Number: 646-501-7300; Email: ran.schwarzkopf@nyulangone.org
      • Contact: Daniel Warren, BA; Phone Number: 212-598-6245; Email: daniel.waren@nyulangone.org
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Rothman Orthopaedic Institute
      • Contact: Paul M Courtney, MD; Phone Number: 267-339-7879; Email: paul.courtney@rothmaninstitute.com
      • Contact: Emanuele Chisari, MD; Phone Number: 267-339-3728; Email: Emanuele.Chisari@rothmanortho.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary THA for a diagnosis of osteoarthritis or inflammatory arthritis in the setting of a history of prior lumbar or lumbosacral fusion performed at least 6 months prior to their THA. In addition, patients considered high-risk for potential prosthetic dislocation will be included based on the presence of one or more of the following: neuromuscular disorder (e.g. cerebral palsy, Parkinson's disease, history of a stroke), dementia or cognitive impairment, substance or alcohol abuse (>10 drinks per week), acute displaced femoral neck fracture, age > 75 years, inflammatory arthritis, and increased preoperative range of motion (calculated as described by Krenzel et al.: combined flexion, adduction, internal rotation > 115 degrees).

Exclusion Criteria:

• Less than 18 years of age
• Revision THA
• spinopelvic fusion that is more recent than 6 months prior to THA
• isolated cervical or thoracic fusion
• intent to undergo a revision spinopelvic fusion within one year of their index THA
• a history of prior infection in the affected hip
• a history of prior open surgery on the affected hip (i.e. prior proximal femur fracture or osteotomy)
• or a preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture

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; Patients in this group will receive a dual mobility hip implant	Device: Dual mobility implant; Patients that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant
Active Comparator: Single bearing, traditional hip implant; Patients in this group will receive a traditional, single-bearing hip implant.	Device: Traditional, Single-bearing hip implant; Patients that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip Dislocation	The rate of prosthetic dislocation between the two cohorts	6 weeks following their index surgical procedure.
Hip Dislocation	The rate of prosthetic dislocation between the two cohorts	1 year following their index surgical procedure.
Hip Dislocation	The rate of prosthetic dislocation between the two cohorts	2 years following their index surgical procedure.
Hip Dislocation	The rate of prosthetic dislocation between the two cohorts	5 years following their index surgical procedure.
Hip Dislocation	The rate of prosthetic dislocation between the two cohorts	10 years following their index surgical procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Any peri- or postoperative complications will be recorded component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates	Complications will be assess up to 10 years following their index surgical procedure
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format	6 weeks following their index surgical procedure.
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format	1 year following their index surgical procedure.
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format	2 years following their index surgical procedure.
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format	5 years following their index surgical procedure.
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format	10 years following their index surgical procedure.

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: New York University; Rothman Institute Orthopaedics; Keck School of Medicine of USC

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Hip Dislocation; Joint Dislocations
• Other Study ID Numbers: 17030101

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