About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

322 Participants

are divided into 2 treatment groups

Group A: Dual MobilityExperimental treatment 1 intervention

Group B: Conventional, Single-bearing hip implantActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Prosthetic Dislocation

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

Time frame

6 weeks

2

Prosthetic Dislocation

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

Time frame

3 months

3

Prosthetic Dislocation

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

Time frame

2 years

4

Prosthetic Dislocation

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

Time frame

5 years

Secondary outcomes

1

Complications

Any peri- or postoperative complications will be recorded, including component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates

Time frame

up to 20 years after the patient is discharged from the hospital

2

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.

Time frame

6 weeks

3

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.

Time frame

3 months

4

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.

Time frame

2 years

Dual Mobility Acetabular Cups in Revision TJA

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts