Comparing dual mobility and single-bearing hip implants for high-risk patients

Dual-mobility vs. Single-bearing Components in THA at "High Risk" for Prosthetic Dislocation

This study is testing whether a special type of hip implant can help high-risk patients, like older adults or those with certain health issues, avoid dislocations after hip surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 412 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rush University Medical Center (Academic / other)
• Locations: 4 sites (Los Angeles, California and 3 other locations)
• Trial ID: NCT04092634 on ClinicalTrials.gov

What this trial studies

This study compares the clinical outcomes of high-risk patients undergoing primary total hip arthroplasty (THA) using dual mobility bearings versus conventional single-bearing designs. It is a randomized controlled trial that aims to determine if dual mobility components can reduce the dislocation rate in the first year post-surgery. The study includes patients with specific risk factors such as neuromuscular disorders, cognitive impairment, and advanced age. The goal is to assess the effectiveness of dual mobility implants in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients over 75 years old or those with conditions like neuromuscular disorders or cognitive impairment who are undergoing primary THA.

Not a fit: Patients under 18 years old or those requiring revision THA will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to lower dislocation rates in high-risk patients undergoing hip replacement surgery.

How similar studies have performed: Other studies have shown promising results with dual mobility implants in reducing dislocation rates, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Primary THA for a diagnosis of osteoarthritis or inflammatory arthritis in the setting of a history of prior lumbar or lumbosacral fusion performed at least 6 months prior to their THA. In addition, patients considered high-risk for potential prosthetic dislocation will be included based on the presence of one or more of the following: neuromuscular disorder (e.g. cerebral palsy, Parkinson's disease, history of a stroke), dementia or cognitive impairment, substance or alcohol abuse (\>10 drinks per week), acute displaced femoral neck fracture, age \> 75 years, inflammatory arthritis, and increased preoperative range of motion (calculated as described by Krenzel et al.: combined flexion, adduction, internal rotation \> 115 degrees).

Exclusion Criteria:

* Less than 18 years of age
* Revision THA
* spinopelvic fusion that is more recent than 6 months prior to THA
* isolated cervical or thoracic fusion
* intent to undergo a revision spinopelvic fusion within one year of their index THA
* a history of prior infection in the affected hip
* a history of prior open surgery on the affected hip (i.e. prior proximal femur fracture or osteotomy)
* or a preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture

Where this trial is running

Los Angeles, California and 3 other locations

• Keck School of Medicine of USC — Los Angeles, California, United States (Recruiting)
• Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
• New York University Medical Center — New York, New York, United States (Not_yet_recruiting)
• Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Denis Nam, MD, MSc

Conditions Dislocation, Hip