Prospective Study Measuring Clinical Outcomes of Knee Arthroplasty Using the VERASENSE™ Knee System
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA), Orthopedic |
| Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2011 |
| End Date: | August 2016 |
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 improved clinical outcomes versus patient with residual imbalance, as
measured by the VERASENSE™ Knee System
Secondary objectives:
- Determine whether a difference in inter-compartment loads and soft tissue tension
exists between the physicians intra-operative feel compared to the quantifiable data
measured by the VERASENSE™ Knee System
- Determine which ligament releases are performed by the surgeon to improve soft tissue
balance while utilizing the information from the VERASENSE™ Knee System
- Evaluate range of motion, pain, physical function, activity level, and patient
satisfaction between baseline (pre-operative) and post-operative follow-up as well as
radiographic success and survivorship of the knee implants
understanding of "balance" 2) To determine if patients with quantifiably balanced knee
joints exhibit improved clinical outcomes versus patient with residual imbalance, as
measured by the VERASENSE™ Knee System
Secondary objectives:
- Determine whether a difference in inter-compartment loads and soft tissue tension
exists between the physicians intra-operative feel compared to the quantifiable data
measured by the VERASENSE™ Knee System
- Determine which ligament releases are performed by the surgeon to improve soft tissue
balance while utilizing the information from the VERASENSE™ Knee System
- Evaluate range of motion, pain, physical function, activity level, and patient
satisfaction between baseline (pre-operative) and post-operative follow-up as well as
radiographic success and survivorship of the knee implants
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
8
sites
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials