Post Approval Study of the Commercially Available U-Motion II+ Acetabular System and UTF Reduced Stem



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 75
Updated:5/4/2018
Start Date:January 2016
End Date:January 2025
Contact:Mindy Carlson
Email:mindy.carlson@uocusa.com
Phone:612-562-0060

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Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U-Motion II+ Acetabular System and UTF Reduced Stem

This is a prospective, single arm, multi-center, post-approval study designed to evaluate the
short and long term clinical performance and safety in subjects receiving primary total hip
arthroplasty (THA) with the U-Motion II+ Acetabular System and UTF Reduced Stem.

This is a prospective, single arm, multi-center, post-approval study designed to evaluate the
short and long term clinical performance and safety in subjects receiving primary total hip
arthroplasty (THA) with the U-Motion II+ Acetabular System and UTF Reduced Stem. The
acetabular and femoral components will be uncemented. Study outcomes will be analyzed and
published when 1.) all enrolled and implanted subjects complete their 6-week follow up, 2.)
all implanted subjects complete their 2-year follow up, 3.) at the conclusion of the study.

It is anticipated that up to 200 subjects will be enrolled at up to 5 sites. The subjects
will be evaluated at predetermined intervals: baseline, procedure/ discharge and 6 weeks, 3
months, 6 months, 12 months, and 24 months post treatment for primary analysis and annually
up to 5 years for device survivorship. The estimated study duration from first enrollment
through completion of the final report is expected to be approximately 7 years.

This study will be conducted at up to 5 investigational sites in the United States with
previous clinical research experience and with adequate population of orthopedic patients
requiring primary total hip arthroplasty.

Inclusion Criteria:

Subjects must meet all of the following criteria to be considered for inclusion in the
study.

1. Subject is between 18 and 75 years of age

2. Subject is indicated for a unilateral or bilateral total hip arthroplasty (THA) based
on the approved labeling of the device

3. Subject has no history of previous prosthetic replacement device or orthopedic
surgeries on the operative hip

4. Subject is willing and able to provide informed consent to participate in the study;

5. Subject is willing and able to understand the purpose of the study, his/her role, and
is available to return to the clinic/hospital for all required follow-up visits;

Exclusion Criteria:

- Subjects will be excluded if, in the opinion of the Investigator, the subject does not
qualify based on approved labeling requirements or Subject Inclusion criteria.
We found this trial at
6
sites
2 Shircliff Way
Jacksonville, Florida 32204
Principal Investigator: Stanton Longenecker, MD
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Dayton, Ohio 45415
Principal Investigator: Thomas Cook, DO
Phone: 937-280-4988
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Dayton, OH
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Kenosha, Wisconsin 53143
Principal Investigator: James Shapiro, MD
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Kenosha, WI
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Naples, Florida 34108
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Naples, FL
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535 E 70th St
New York, New York 10021
(212) 606-1000
Principal Investigator: Edwin Su, MD
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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Philadelphia, Pennsylvania 19104
Principal Investigator: Gwo-Chin Lee
Phone: 215-294-9172
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Philadelphia, PA
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