Clinical trial NCT04090359: Dual Mobility Acetabular Cups in Revision TJA
Official title: Dual Mobility Acetabular Cups in Revision TJA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dislocation, Hip
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Rothman Institute Orthopaedics
name: Keck School of Medicine of USC
name: NYU Langone Health
First posted: 2019-09-16
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Prosthetic Dislocation
timeFrame: 6 weeks
measure: Prosthetic Dislocation
timeFrame: 3 months
measure: Prosthetic Dislocation
timeFrame: 2 years
measure: Prosthetic Dislocation
timeFrame: 5 years
measure: Prosthetic Dislocation
timeFrame: 10 years
measure: Prosthetic Dislocation
timeFrame: 15 years
measure: Prosthetic Dislocation
timeFrame: 20 years
Secondary outcomes:
measure: Complications
timeFrame: up to 20 years after the patient is discharged from the hospital
measure: Routine radiographs assess for loosening and proper component placement
timeFrame: 6 weeks
measure: Routine radiographs assess for loosening and proper component placement
timeFrame: 3 months
measure: Routine radiographs assess for loosening and proper component placement
timeFrame: 2 years
measure: Routine radiographs assess for loosening and proper component placement
timeFrame: 5 years
measure: Routine radiographs assess for loosening and proper component placement
timeFrame: 10 years
measure: Routine radiographs assess for loosening and proper component placement
timeFrame: 15 years
measure: Routine radiographs assess for loosening and proper component placement
timeFrame: 20 years.
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References: