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 |
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.
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
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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