Dual Mobility Acetabular Cups in Revision TJA

Dislocation, Hip Clinical Trial

Official title:

Dual Mobility Acetabular Cups in Revision TJA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04090359
• Other study ID #: 17022801
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2017
• Est. completion date: October 1, 2034

Study information

• Verified date: June 2024
• Source: Rush University Medical Center
• Contact: Craig Della Valle, MD
• Phone: (312)432-2468
• Email: craig.dellavalle[@]rushortho.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 322
• Est. completion date: October 1, 2034
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dislocation, Hip
• Hip Dislocation

Intervention

Device:
• Dual Mobility Implant
Patients in this intervention will receive a dual mobility implant
• Conventional, single-bearing implant
Patients in this intervention will receive a conventional, single-bearing implant

Locations

Country	Name	City	State
United States	New York University Medical Center	New York	New York
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Rush University Medical Center	NYU Langone Health, Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prosthetic Dislocation	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits	6 weeks
Primary	Prosthetic Dislocation	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits	3 months
Primary	Prosthetic Dislocation	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits	2 years
Primary	Prosthetic Dislocation	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits	5 years
Primary	Prosthetic Dislocation	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits	10 years
Primary	Prosthetic Dislocation	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits	15 years
Primary	Prosthetic Dislocation	The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits	20 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.