Dual Mobility in "High Risk" Patients

Phase 4

Recruiting

• Conditions: Dislocation, Hip
• Interventions: Device: Dual mobility implant; Device: Traditional, Single-bearing hip implant

• Registration Number: NCT04092634
• Lead Sponsor: Rush University Medical Center

Brief Summary

The aim of this study is to compare clinical outcomes of patients considered to be high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single bearing design.

Detailed Description

This study aims to compare the clinical outcomes of patients considered to be at high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single-bearing design.

We hypothesize that in primary THA patients considered to be at high risk for prosthetic dislocation, the use of dual-mobility components will be associated with a lower dislocation rate in the first year following the index procedure. We do not anticipate a difference. In other clinical outcome measures or functional outcome scores between the two cohorts.

Study Design: Randomized controlled trial with two groups: THA with dual mobility.

44 components vs THA with single-bearing designs

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-06-01
• Study Completion: 2035-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 412

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual mobility	Dual mobility implant	Patients in this group will receive a dual mobility hip implant
Single bearing, traditional hip implant	Traditional, Single-bearing hip implant	Patients in this group will receive a traditional, single-bearing hip implant.

Primary Outcome Measures

Name	Time	Method
Hip Dislocation	10 years following their index surgical procedure.	The rate of prosthetic dislocation between the two cohorts

Secondary Outcome Measures

Name	Time	Method
Radiographic signs of loosening and proper component placement.	10 years following their index surgical procedure.	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. These radiographs will be assess for the presence of loosening in a yes/no format
Complications	Complications will be assess up to 10 years following their index surgical procedure	Any peri- or postoperative complications will be recorded component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates

Trial Locations

Locations (4)

Keck School of Medicine of USC; 🇺🇸 Los Angeles, California, United States

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

New York University Medical Center; 🇺🇸 New York, New York, United States