Triathlon Total Stabilizer (TS) Outcomes Study



Status:Active, not recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:8/10/2018
Start Date:July 2009
End Date:April 2019

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A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Total Stabilizer (TS) Total Knee System

This study will be a prospective, non-randomized evaluation of the change between
preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee
System for a revision knee operation. The mean total Knee Society Score (for pain, motion and
function) change is not 10% worse than, or is superior to, the expected change according to
published revision total knee replacement data, for cases implanted with the Triathlon® TS
Total Knee System as compared from preoperative to 2 years postoperative.


Inclusion Criteria:

- Patient has signed an IRB approved, study specific Informed Patient Consent Form.

- Patient is a male or non-pregnant female age 18 years or older at time of study device
implantation.

- Patient is a candidate for revision of all femoral and tibial components of a total
knee replacement.

- Patient is willing and able to comply with postoperative scheduled clinical and
radiographic evaluations and rehabilitation.

Exclusion Criteria:

- Patient has a Body Mass Index (BMI) > 40.

- Patient has an active or suspected latent infection in or about the affected knee
joint at time of study device implantation.

- Patient has a neuromuscular or neurosensory deficiency, which limits the ability to
evaluate the safety and efficacy of the device.

- Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic
disorder (e.g. Paget's Disease) leading to progressive bone deterioration.

- Patient is immunologically suppressed or receiving steroids in excess of normal
physiological requirements (e.g. > 30 days).

- Patient has a failed unicondylar knee prosthesis.

- Patient has a known sensitivity to device materials.

- Patient is a prisoner.
We found this trial at
12
sites
Egg Harbor Township, New Jersey 08234
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Egg Harbor Township, NJ
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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Jacksonville, FL
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Chicago, Illinois 60612
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Chicago, IL
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Cincinnati, OH
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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East Syracuse, New York 13057
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East Syracuse, NY
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Phoenix, Arizona 85023
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Phoenix, AZ
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Ridgewood, New Jersey 07450
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Ridgewood, NJ
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Temple, Texas 76508
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Temple, TX
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Tulsa, Oklahoma 74120
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Tulsa, OK
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