Post-Market Clinical Follow-up Study of the REDAPT Monolithic Sleeveless Stem and Acetabular Components Devices Used for Hip Replacement Surgery.



Status:Enrolling by invitation
Healthy:No
Age Range:18 - Any
Updated:3/9/2019
Start Date:May 7, 2018
End Date:December 1, 2028

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A Multicenter, Post-Market Clinical Follow-up Study of Subjects With REDAPT Revision Monolithic Sleeveless Stem and/or Acetabular Components Previously Implanted

The primary purpose of this study is to demonstrate cumulative revision rate of the REDAPT
Revision Femoral System Monolithic Sleeveless Stem and Acetabular Components at 10 years

Retrospective-prospective, single arm, multi-center study of subjects previously implanted
with the REDAPT Revision Femoral System Monolithic Sleeveless Stems and/or Acetabular
Components

Inclusion Criteria:

- Subject has undergone hip arthroplasty with the REDAPT Revision Femoral System
Monolithic stem and/or cup Acetabular Components with implantation prior to date of
Site Initiation Visit to active study.

- Subject required surgery with REDAPT device chosen for the following indications:

i. Complex Primary THA ii. Conversion THA iii. Periprosthetic fracture iv. Revision
THA

- Subject is willing to consent to and to follow the study visit schedule (as defined in
the study protocol and informed consent form), by signing the IRB/EC approved informed
consent form.

- Subject is willing and able to participate in required follow-up visits at the
investigational site and to complete study procedures.

Exclusion Criteria:

- Subject surgery with REDAPT device chosen due to S/P spacer placement infection.

- Subject, in the opinion of the principal investigator (PI), has an emotional or
neurological condition that would pre-empt their ability or willingness to participate
in the study including mental illness, mental retardation, drug or alcohol abuse.

- Subject is known to be at risk for loss to follow-up or failure to return for
scheduled visits.

- Subject is incarcerated or is pending incarceration.

- Subject enrolled in another clinical study that would affect the endpoints of the
study.
We found this trial at
6
sites
New York, New York 10016
Principal Investigator: Ran Schwarzkopf, MD
Phone: 212-460-0176
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Houston, Texas 77030
Principal Investigator: Terry Clyburn, MD
Phone: 713-441-3958
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Houston, TX
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New York, New York 10021
Principal Investigator: David Mayman, MD
Phone: 646-714-6084
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New York, NY
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Rancho Mirage, California 92270
Principal Investigator: Erik Schnaser, MD
Phone: 760-766-2540
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Rancho Mirage, CA
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Reno, Nevada 89503
Principal Investigator: Jackson Jones, MD
Phone: 775-788-5190
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Reno, NV
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435 H Street
San Diego, California 91910
Principal Investigator: David Fabi, MD
Phone: 619-565-9040
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San Diego, CA
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