Dual Mobility Acetabular Cups in Revision TJA

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Primary Purpose

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dual Mobility Implant

Conventional, single-bearing implant

About this trial

This is an interventional prevention trial for Dislocation, Hip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

New York University Medical Center
Rothman InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dual Mobility

Conventional, Single-bearing hip implant

Arm Description

If patients are randomized to the dual mobility cohort, they will receive a dual mobility prosthesis at the surgeon's discretion. All surgeries will be performed via the posterior approach, per the participating surgeon's usual standard. Patients will be on postoperative hip precautions for 6 weeks, per departmental protocol. No braces will be utilized.

If patients are randomized to the conventional, single bearing cohort, surgeons will use their preferred implant design at their discretion using a 36 or 40mm head, depending on the diameter of the cup and manufacturer specifications. All surgeries will be performed via the posterior approach, per the participating surgeon's usual standard. Patients will be on postoperative hip precautions for 6 weeks, per departmental protocol. No braces will be utilized.

Outcomes

Primary Outcome Measures

Prosthetic Dislocation

The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

Prosthetic Dislocation

The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

Prosthetic Dislocation

The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

Prosthetic Dislocation

The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

Prosthetic Dislocation

The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

Prosthetic Dislocation

The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

Prosthetic Dislocation

The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits

Secondary Outcome Measures

Complications

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

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.