Dislocation, Hip
Conditions
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.
Interventions
DEVICEDual Mobility Implant
Patients in this intervention will receive a dual mobility implant
DEVICEConventional, single-bearing implant
Patients in this intervention will receive a conventional, single-bearing implant
Sponsors
Rush University Medical Center
Rothman Institute Orthopaedics
Keck School of Medicine of USC
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prosthetic Dislocation | 6 weeks | The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | up to 20 years after the patient is discharged from the hospital | Any peri- or postoperative complications will be recorded, including component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates |
| Routine radiographs assess for loosening and proper component placement | 6 weeks | 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. |
Countries
United States
Contacts
CONTACTCraig Della Valle, MD
CONTACTAnne DeBenedetti, BA
Outcome results
None listed