Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis Clinical Trial
Official title:
Prospective Study Measuring Clinical Outcomes of Knee Arthroplasty Using the VERASENSE™ Knee System
| Verified date | January 2017 |
| Source | Orthosensor, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 285 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory Healthcare - St. Joseph's Research Institute | Atlanta | Georgia |
| United States | Holy Cross Orthopedic Institute | Fort Lauderdale | Florida |
| United States | Spectrum Health/Orthopaedic Associates of Michigan | Grand Rapids | Michigan |
| United States | University of Wisconsin | Madison | Wisconsin |
| United States | Naples Community Hospital | Naples | Florida |
| United States | Trinity Health/Bone and Joint Institute | Port Huron | Michigan |
| United States | St. Helena Hospital | St. Helena | California |
| United States | Tampa General/FORE | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Orthosensor, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Joint Balance | At time of Total Knee Surgery | No | |
| Secondary | Patient Reported Outcome Measures | Changes from Baseline at 3-years | No |