Phase
Condition
Hip Replacement
Orthopedic Surgery
Treatment
REDAPT
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects must meet all of the inclusion criteria to enroll in the study:
Subject was considered skeletally mature at the time of surgery and was at least 18years of age.
Subject has undergone hip arthroplasty with the REDAPT Fully Porous Acetabular Shellwith XLPE liner or REDAPT Modular Cup Components (with or without Staple, Slice andBlade Augments), and/or Monolithic Sleeveless Stem, and/or Monolithic Sleeved Stemand are at least 3 months post-implantation at this site.
Subject required surgery with REDAPT device chosen for one of the followingindications:
Advanced degeneration of the hip joint as result of osteoarthritis, avascularnecrosis, posttraumatic arthritis, rheumatoid arthritis, or dysplasia (or anyof the composites of these conditions).
Fracture-dislocation of the hip, femoral neck fracture or trochantericfractures of the proximal femur with head involvement that are unmanageableusing other techniques.
Revision THA
Subject is willing to consent to and to follow the study visit schedule (as definedin the study protocol and ICF), by signing the IRB/IEC approved ICF.
Subject is willing and able to participate in required follow-up visits at theinvestigational site and to complete study procedures.
Exclusion
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria will be excluded from study participation:
Subject had an active infection - systemic or at the site of surgery.
Subject, in the opinion of the PI, has an emotional or neurological condition thatwould pre-empt their ability or willingness to participate in the study includingmental illness, mental retardation, drug or alcohol abuse.
Subject is known to be at risk for loss to follow-up or failure to return forscheduled visits.
Subject is incarcerated or is pending incarceration.
Subject is enrolled in another clinical study that would affect the endpoints of thestudy.
Study Design
Study Description
Connect with a study center
Eisenhower Medical Center-Hospital
Rancho Mirage, California 92270
United StatesSite Not Available
Scripps Mercy
San Diego, California 92103
United StatesSite Not Available
Reno Orthopaedic Clinic
Reno, Nevada 89503
United StatesSite Not Available
Hospital for Surgery- New York
New York, New York 10021
United StatesSite Not Available
NYU Langone Health Orthopedic Hospital
New York, New York 10003
United StatesSite Not Available
Houston Methodist Hospital Department of Orthopedic Surgery
Houston, Texas 77030
United StatesSite Not Available
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