Status:
COMPLETED
Prospective Study Measuring Clinical Outcomes of Knee Arthroplasty Using the VERASENSE™ Knee System
Lead Sponsor:
Orthosensor, Inc.
Conditions:
Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis
Eligibility:
All Genders
50+ years
Brief Summary
The primary objectives of this evaluation are: 1) To attempt to refine the current clinical understanding of "balance" 2) To determine if patients with quantifiably balanced knee joints exhibit improv...
Eligibility Criteria
Inclusion
- Subject must be a candidate for a primary total knee replacement
- Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis post-traumatic arthritis
- Subject's joint must be anatomically and functionally suited to receive the selected implant
- Subject is 50 years of age or older (≥ 50 yrs) at the time of consent
- Subject is likely to be available for all study visits
- Subject is able and willing to sign the informed consent and follow study procedures
- Subject is not pregnant
Exclusion
- Prior total knee arthroplasty
- Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- Subject is pregnant
- Subject has an active infection or joint sepsis
- Subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Multiple Sclerosis, and Charcot joints)
- Ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
- Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT01469299
Start Date
October 1 2011
End Date
December 1 2016
Last Update
January 11 2017
Active Locations (8)
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1
St. Helena Hospital
St. Helena, California, United States, 94574
2
Holy Cross Orthopedic Institute
Fort Lauderdale, Florida, United States, 33334
3
Naples Community Hospital
Naples, Florida, United States, 34102
4
Tampa General/FORE
Tampa, Florida, United States, 33637