Back to resultsDual Mobility in "High Risk" Patients
Primary Purpose
Dislocation, Hip
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dual mobility implant
Traditional, Single-bearing hip implant
Sponsored by
About this trial
This is an interventional prevention trial for Dislocation, Hip
Eligibility Criteria
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
Sites / Locations
- Keck School of Medicine of USCRecruiting
- Rush University Medical CenterRecruiting
- New York University Medical Center
- Rothman Orthopaedic InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dual mobility
Single bearing, traditional hip implant
Arm Description
Patients in this group will receive a dual mobility hip implant
Patients in this group will receive a traditional, single-bearing hip implant.
Outcomes
Primary Outcome Measures
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Hip Dislocation
The rate of prosthetic dislocation between the two cohorts
Secondary Outcome Measures
Complications
Any peri- or postoperative complications will be recorded component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates
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
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
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
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
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
Full Information
NCT ID
NCT04092634
First Posted
September 11, 2019
Last Updated
October 27, 2022
Sponsor
Rush University Medical Center
Collaborators
New York University, Rothman Institute Orthopaedics, Keck School of Medicine of USC
1. Study Identification
Unique Protocol Identification Number
NCT04092634
Brief Title
Dual Mobility in "High Risk" Patients
Official Title
Dual-mobility vs. Single-bearing Components in THA at "High Risk" for Prosthetic Dislocation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2033 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
New York University, Rothman Institute Orthopaedics, Keck School of Medicine of USC
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 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.
Detailed Description
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.
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: THA with dual mobility components vs THA with single-bearing designs.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
412 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dual mobility
Arm Type
Experimental
Arm Description
Patients in this group will receive a dual mobility hip implant
Arm Title
Single bearing, traditional hip implant
Arm Type
Active Comparator
Arm Description
Patients in this group will receive a traditional, single-bearing hip implant.
Intervention Type
Device
Intervention Name(s)
Dual mobility implant
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Traditional, Single-bearing hip implant
Intervention Description
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
Primary Outcome Measure Information:
Title
Hip Dislocation
Description
The rate of prosthetic dislocation between the two cohorts
Time Frame
6 weeks following their index surgical procedure.
Title
Hip Dislocation
Description
The rate of prosthetic dislocation between the two cohorts
Time Frame
1 year following their index surgical procedure.
Title
Hip Dislocation
Description
The rate of prosthetic dislocation between the two cohorts
Time Frame
2 years following their index surgical procedure.
Title
Hip Dislocation
Description
The rate of prosthetic dislocation between the two cohorts
Time Frame
5 years following their index surgical procedure.
Title
Hip Dislocation
Description
The rate of prosthetic dislocation between the two cohorts
Time Frame
10 years following their index surgical procedure.
Secondary Outcome Measure Information:
Title
Complications
Description
Any peri- or postoperative complications will be recorded component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates
Time Frame
Complications will be assess up to 10 years following their index surgical procedure
Title
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format
Time Frame
6 weeks following their index surgical procedure.
Title
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format
Time Frame
1 year following their index surgical procedure.
Title
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format
Time Frame
2 years following their index surgical procedure.
Title
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format
Time Frame
5 years following their index surgical procedure.
Title
Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format
Time Frame
10 years following their index surgical procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denis Nam, MD, MSc
Phone
(312)432-2468
Email
denis.nam@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
Keck School of Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathan Heckmann, MD
First Name & Middle Initial & Last Name & Degree
Brian Chung
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne DeBenedetti, BA
Phone
312-432-2468
Email
anne.debenedetti@rushortho.com
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
Phone
646-501-7300
Email
ran.schwarzkopf@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Daniel Warren, BA
Phone
212-598-6245
Email
daniel.waren@nyulangone.org
Facility Name
Rothman Orthopaedic 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
Paul M Courtney, MD
Phone
267-339-7879
Email
paul.courtney@rothmaninstitute.com
First Name & Middle Initial & Last Name & Degree
Emanuele Chisari, MD
Phone
267-339-3728
Email
Emanuele.Chisari@rothmanortho.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Dual Mobility in "High Risk" Patients
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