ACTIVE_NOT_RECRUITING

Dual Mobility in "High Risk" Patients

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Conditions

Dislocation, Hip

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-11-01
Study Completion:2035-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04092634

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  1. * Less than 18 years of age
  2. * Revision THA
  3. * spinopelvic fusion that is more recent than 6 months prior to THA
  4. * isolated cervical or thoracic fusion
  5. * intent to undergo a revision spinopelvic fusion within one year of their index THA
  6. * a history of prior infection in the affected hip
  7. * a history of prior open surgery on the affected hip (i.e. prior proximal femur fracture or osteotomy)
  8. * or a preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture

Contacts and Locations

Study Locations (Sites)

Keck School of Medicine of USC
Los Angeles, California, 90033
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
New York University Medical Center
New York, New York, 10003
United States
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Rush University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-11-01
Study Completion Date2035-02-01

Study Record Updates

Study Start Date2017-11-01
Study Completion Date2035-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Dislocation, Hip