Dual Mobility Acetabular Cups in Revision TJA

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04090359
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Rush University Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Dislocation, Hip

Additional Details

Arms & Interventions

Arms

Experimental: Dual Mobility

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.

Active Comparator: Conventional, Single-bearing hip implant

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.

Interventions

Device: - Dual Mobility Implant

Patients in this intervention will receive a dual mobility implant

Device: - Conventional, single-bearing implant

Patients in this intervention will receive a conventional, single-bearing implant

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York University Medical Center, New York, New York

Status

Not yet recruiting

Address

New York University Medical Center

New York, New York, 10003

Site Contact

Ran Schwarzkopf, MD

[email protected]

(312)432-2468

Rothman Institute, Philadelphia, Pennsylvania

Status

Recruiting

Address

Rothman Institute

Philadelphia, Pennsylvania, 19107

Site Contact

Max Courtney, MD

[email protected]

(312)432-2468

Clinical Trial Finder